CLIN TRIALS GOV REGISTERED CLINICAL STUDIES FOR CELL THERAPY IN CRITICAL LIMB ISCHEMIA 31.8.2015
Study 1: NCT Number: NCT00721006 Title: Phase II Combination Stem Cell Therapy for the Treatment of Severe Leg Ischemia Recruitment: Completed Sponsor/Collaborators: TCA Cellular Therapy Phases: Phase 2 Completion Date: September 2010 Acronym: MESENDO Results First Received: No Study Results Posted Primary Completion Date: August 2010 Outcome Measures: Enhancement of vessel formation accessed by Nuclear Perfusion Scan in critical limb ischemia.|Changes in resting leg pain identified by a Visual Analog Scale and patient safety
Study 2: NCT Number: NCT00956332 Title: Safety Study of MultiGeneAngio in Patients With Chronic Critical Limb Ischemia Recruitment: Active, not recruiting Sponsor/Collaborators: MultiGene Vascular Systems Ltd. Phases: Phase 1|Phase 2 Start Date: February 2010 Outcome Measures: The safety of MultiGeneAngio will be assessed by monitoring adverse events|Improvement in critical limb ischemia symptoms
Study 3: NCT Number: NCT01595776 Title: Autologous Endothelial Progenitor Cells (EPCs) From Peripheral Blood in the Treatment of Critical Limb Ischemia Recruitment: Completed Interventions: Other: Endothelial progenitor cells intramuscular implant Sponsor/Collaborators: IRCCS Policlinico S. Matteo Phases: Phase 1|Phase 2 Completion Date: December 2011 Outcome Measures: Contrast enhanced ultrasound (CEUS)|Pain relief|ulcer healing
Study 4: NCT Number: NCT01408381 Title: Intra-arterial Infusion of Autologous Bone Marrow Mononuclear Cells in Non-diabetic Patients With Critical Limb Ischemia (CLI). Recruitment: Completed Study Results: No Results Available Conditions: Critical Limb Ischemia (CLI) Interventions: Other: Intraarterial Infusion of Autologous Bone Marrow Mononuclear Cells Sponsor/Collaborators: Andalusian Initiative for Advanced Therapies - Fundaci_存n P__blica Andaluza Progreso y Salud|Iniciativa Andaluza en Terapias Avanzadas Gender: Both Age Groups: Adult|Senior Phases: Phase 2 Enrollment: 38 Funded Bys: Other Study Types: Interventional Study Designs: Allocation: Randomized|Endpoint Classification: Safety/Efficacy Study|Intervention Model: Parallel Assignment|Primary Purpose: Treatment|Masking: Open Label Other IDs: CMMo/ICC/2009|2009-013636-20 First Received: August 1, 2011 Start Date: January 2011 Completion Date: June 2015 Last Updated: August 4, 2015 Last Verified: November 2014 Acronym: null Results First Received: No Study Results Posted Primary Completion Date: June 2015 Outcome Measures: Adverse events|Ankle-brachial index|Transcutaneous oxygen pressure (TcO2)|Greater ulcer size|Degree of Rutherford-Becker|Perimeter calf muscle|Presence of faster opacity in infrapopliteal vessels at 6 months compared with the basal situation of the patient. URL: https://ClinicalTrials.gov/show/NCT01408381
Study 5: NCT Number: NCT00371371 Title: Intra-arterial Stem Cell Therapy for Patients With Chronic Limb Ischemia (CLI) Recruitment: Completed Study Results: No Results Available Conditions: Peripheral Vascular Diseases|Arterial Occlusive Diseases|Leg Ulcer|Gangrene|Ischemia Interventions: Procedure: Bone marrow punction|Procedure: BM-MNC infusion|Procedure: Placebo infusion Sponsor/Collaborators: UMC Utrecht|Catharijne Foundation Gender: Both Age Groups: Adult|Senior Phases: Phase 1|Phase 2 Enrollment: 160 Funded Bys: Other Study Types: Interventional Study Designs: Allocation: Randomized|Endpoint Classification: Safety/Efficacy Study|Intervention Model: Parallel Assignment|Primary Purpose: Treatment|Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Other IDs: JUVENTAS|06/030|CS 06.007 First Received: September 1, 2006 Start Date: September 2006 Completion Date: December 2012 Last Updated: December 12, 2012 Last Verified: December 2012 Acronym: JUVENTAS Results First Received: No Study Results Posted Primary Completion Date: December 2012 Outcome Measures: major amputation|minor amputation|number and extent of leg ulcers|resolvement of rest pain|improvement of ankle-brachial index (ABI) |improvement transcutaneous oxygen pressure (TcpO2)|changes in quality of life|changes in clinical status (Rutherford classification) URL: https://ClinicalTrials.gov/show/NCT00371371
Study 6: NCT Number: NCT00533104 Title: Cell Therapy in Chronic Limb Ischemia Recruitment: Completed Study Results: No Results Available Conditions: Peripheral Vascular Diseases Interventions: Procedure: BM-MNC preparation|Procedure: PB-MNC preparation Sponsor/Collaborators: CHU de Reims Gender: Both Age Groups: Adult|Senior Phases: Phase 1|Phase 2 Enrollment: 40 Funded Bys: Other Study Types: Interventional Study Designs: Allocation: Non-Randomized|Endpoint Classification: Safety/Efficacy Study|Intervention Model: Single Group Assignment|Primary Purpose: Treatment|Masking: Open Label
Other IDs: PHRC R_©gion 2003 / R11-05 / 95 First Received: September 19, 2007 Start Date: October 2004 Completion Date: February 2009 Last Updated: February 5, 2009 Last Verified: February 2009 Acronym: null Results First Received: No Study Results Posted Primary Completion Date: February 2009 Outcome Measures: Survival without major amputation|clinical symptoms and haemodynamic parameters URL: https://ClinicalTrials.gov/show/NCT00533104
Study 7: NCT Number: NCT00872326 Title: Autologous Bone Marrow Derived Mononuclear Cells in Treating Diabetic Patients With Critical Limb Ischemia Recruitment: Completed Study Results: No Results Available Conditions: Peripheral Vascular Diseases|Diabetic Foot Interventions: Procedure: Autologous Bone Marrow Mononuclear Cells Sponsor/Collaborators: Andalusian Initiative for Advanced Therapies - Fundaci_¸n P__blica Andaluza Progreso y Salud|Carlos III Health Institute Gender: Both Age Groups: Adult|Senior Phases: Phase 1|Phase 2 Enrollment: 20 Funded Bys: Other Study Types: Interventional Study Designs: Endpoint Classification: Safety/Efficacy Study|Intervention Model: Single Group Assignment|Primary Purpose: Treatment|Masking: Open Label Other IDs: C/ICPD/2007|FPS C/ICPD/2007 First Received: March 30, 2009 Start Date: December 2007 Completion Date: May 2009 Last Updated: November 13, 2014 Last Verified: November 2014 Acronym: null Results First Received: No Study Results Posted Primary Completion Date: April 2009 Outcome Measures: Angiographic evaluation of angiogenesis and vasculogenesis at target limb|Ankle-Brachial pressure index URL: https://ClinicalTrials.gov/show/NCT00872326
Study 8: NCT Number: NCT02140931 Title: A Clinical Study to Assess Blood-Borne Autologous Angiogenic Cell Precursors Therapy in Patients With Critical Limb Ischemia Recruitment: Recruiting Study Results: No Results Available Conditions: Critical Limb Ischemia Interventions: Biological: Angiogenic Cell Precursors Sponsor/Collaborators: Hemostemix Gender: Both Age Groups: Adult|Senior Phases: Phase 2 Enrollment: 100 Funded Bys: Industry Study Types: Interventional Study Designs: Allocation: Randomized|Endpoint Classification: Safety/Efficacy Study|Intervention Model: Parallel Assignment|Primary Purpose: Treatment|Masking: Double Blind (Subject, Investigator) Other IDs: HS 12-01 First Received: May 14, 2014 Start Date: August 2014 Completion Date: July 2016 Last Updated: August 21, 2014 Last Verified: August 2014 Acronym: null Results First Received: No Study Results Posted Primary Completion Date: December 2015 Outcome Measures: Time to major amputation / mortality|Change from baseline in the level of pain in the treated ischemic leg|Change from baseline in the quantity of analgesic drugs used by the patient|Change from baseline in ABI (Ankle Brachial Index)|Change from baseline in TBI (Toe Brachial Index)|Change from baseline in quality of life|Change from baseline in ulcer size|Total hospitalization time of ACP-treated patients compared to controls URL: https://ClinicalTrials.gov/show/NCT02140931
Study 9: NCT Number: NCT00518401 Title: Combination Stem Cell Therapy for the Treatment of Severe Leg Ischemia Recruitment: Completed Study Results: No Results Available Conditions: Critical Limb Ischemia|Peripheral Vascular Disease Interventions: Biological: Mesendo Sponsor/Collaborators: TCA Cellular Therapy Gender: Both Age Groups: Adult|Senior Phases: Phase 1 Enrollment: 10 Funded Bys: Industry Study Types: Interventional Study Designs: Allocation: Randomized|Endpoint Classification: Safety/Efficacy Study|Intervention Model: Single Group Assignment|Primary Purpose: Treatment|Masking: Open Label Other IDs: 2007-01-I First Received: August 16, 2007 Start Date: June 2007 Completion Date: October 2009 Last Updated: April 27, 2011 Last Verified: February 2010 Acronym: mesendo Results First Received: No Study Results Posted Primary Completion Date: August 2008 Outcome Measures: Safety URL: https://ClinicalTrials.gov/show/NCT00518401
Study 10: NCT Number: NCT02287974 Title: Clinical Trial I/II Opened, Randomized and Controlled for the Study of the Use of Stem Cells Therapy in Insulinized Diabetic Patients Type 2 With Critical Ischemia in Lower Limbs (CLI): Study of the Needs of Insulin Recruitment: Recruiting Study Results: No Results Available Conditions: Critical Limb Ischemia (CLI) Interventions: Drug: Stem cell infusion Sponsor/Collaborators: Andalusian Initiative for Advanced Therapies - Fundaci_¸n P__blica Andaluza Progreso y Salud|Iniciativa Andaluza en Terapias Avanzadas Gender: Both Age Groups: Adult|Senior Phases: Phase 1|Phase 2 Enrollment: 48 Funded Bys: Other Study Types: Interventional
Study Designs: Allocation: Randomized|Endpoint Classification: Safety/Efficacy Study|Intervention Model: Parallel Assignment|Primary Purpose: Treatment|Masking: Open Label Other IDs: CeTMMoTa/ICPDI/2010 First Received: February 25, 2013 Start Date: September 2011 Completion Date: December 2015 Last Updated: June 12, 2015 Last Verified: November 2014 Acronym: null Results First Received: No Study Results Posted Primary Completion Date: December 2015 Outcome Measures: Serious Adverse Events|Efficacy measured by: The changes in the requirements of insulin, Peptide C, Resistance to the insulin, inflammatory Cytokines, pancreatic Reservation, Quantification of the degree of neovascularization (angio/arteriogenesis and vasculogenesis) URL: https://ClinicalTrials.gov/show/NCT02287974
Study 11: NCT Number: NCT00904501 Title: Bone Marrow Autograft in Limb Ischemia Recruitment: Recruiting Study Results: No Results Available Conditions: Peripheral Vascular Diseases|Limb Ishemia Interventions: Procedure: Bone marrow harvest|Procedure: Bone marrow harvest Sponsor/Collaborators: CHU de Reims|Etablissement Fran_造ais du Sang Gender: Both Age Groups: Adult|Senior Phases: Phase 3 Enrollment: 110 Funded Bys: Other Study Types: Interventional Study Designs: Allocation: Non-Randomized|Endpoint Classification: Efficacy Study|Intervention Model: Parallel Assignment|Primary Purpose: Treatment|Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Other IDs: PHRC2007- N11-02 First Received: May 18, 2009 Start Date: March 2009 Completion Date: June 2014 Last Updated: March 12, 2012 Last Verified: March 2012 Acronym: BALI Results First Received: No Study Results Posted Primary Completion Date: December 2013 Outcome Measures: Major amputation rate and mortality|Clinical symptoms and haemodynamical parameters URL: https://ClinicalTrials.gov/show/NCT00904501
Study 12: NCT Number: NCT00922389 Title: A Clinical Trial on Diabetic Foot Using Peripheral Blood Derived Stem Cells for Treating Critical Limb Ischemia Recruitment: Not yet recruiting Study Results: No Results Available Conditions: Diabetic Foot|Critical Limb Ischemia|Leg Ulcers Interventions: Procedure: will receive G-CSF and peripheral blood derived mononuclear cells|Drug: G-CSF|Drug: Standard Therapy Sponsor/Collaborators: Beike Biotech India Pvt.ltd Gender: Both Age Groups: Adult Phases: Phase 1|Phase 2 Enrollment: 36 Funded Bys: Industry Study Types: Interventional Study Designs: Allocation: Randomized|Endpoint Classification: Safety/Efficacy Study|Intervention Model: Parallel Assignment|Primary Purpose: Treatment|Masking: Open Label Other IDs: CNS-P0-V1 First Received: June 16, 2009 Start Date: July 2009 Completion Date: January 2011 Last Updated: June 16, 2009 Last Verified: June 2009 Acronym: null Results First Received: No Study Results Posted Primary Completion Date: January 2010 Outcome Measures: Adverse events and laboratory parameters|Trans Cutaneous partial pressure of Oxygen: TCpO2 URL: https://ClinicalTrials.gov/show/NCT00922389
Study 13: NCT Number: NCT01049919 Title: Safety and Efficacy Study of Autologous Concentrated Bone Marrow Aspirate (cBMA) for Critical Limb Ischemia (CLI) Recruitment: Active, not recruiting Study Results: No Results Available Conditions: Critical Limb Ischemia|Peripheral Arterial Disease|Peripheral Vascular Disease Interventions: Device: Bone marrow concentration device|Procedure: Placebo procedure (sham) Sponsor/Collaborators: Biomet Biologics, LLC|Biomet, Inc. Gender: Both Age Groups: Adult|Senior Phases: Enrollment: 152 Funded Bys: Industry Study Types: Interventional Study Designs: Allocation: Randomized|Endpoint Classification: Safety/Efficacy Study|Intervention Model: Parallel Assignment|Primary Purpose: Treatment|Masking: Double Blind (Subject, Outcomes Assessor) Other IDs: BB-IDE 13996|BBIO.CR.CT002 First Received: January 14, 2010 Start Date: June 2010 Completion Date: May 2020 Last Updated: June 24, 2015 Last Verified: June 2015 Acronym: MOBILE Results First Received: No Study Results Posted Primary Completion Date: May 2016 Outcome Measures: Time to treatment failure|Perfusion and quality of life measurements URL: https://ClinicalTrials.gov/show/NCT01049919
Study 14: NCT Number: NCT01351610 Title: Tolerability and Efficacy of Intravenous Infusion of Autologous MSC_Apceth for the Treatment of Critical Limb Ischemia Recruitment: Terminated Study Results: No Results Available Conditions: Critical Limb Ischemia|Peripheral Artery Disease Interventions: Biological: PTA + Infusion of MSC_Apceth|Procedure: PTA Sponsor/Collaborators: Apceth GmbH & Co. KG Gender: Both Age Groups: Adult|Senior Phases: Phase 1|Phase 2 Enrollment: 30 Funded Bys: Industry Study Types: Interventional Study Designs: Allocation: Randomized|Endpoint Classification: Safety/Efficacy Study|Intervention Model: Parallel Assignment|Primary Purpose: Treatment|Masking: Open Label Other IDs: MSC_Apceth_001
First Received: May 10, 2011 Start Date: March 2011 Completion Date: December 2014 Last Updated: November 5, 2014 Last Verified: November 2014 Acronym: null Results First Received: No Study Results Posted Primary Completion Date: October 2014 Outcome Measures: Collection of adverse events|Safety laboratory values|ECG findings|Analysis of inflammation markers|Comparison of course of haemodynamic and vascular processes URL: https://ClinicalTrials.gov/show/NCT01351610
Study 15: NCT Number: NCT01483898 Title: An Efficacy and Safety Study of Ixmyelocel-T in Patients With Critical Limb Ischemia (CLI) Recruitment: Active, not recruiting Study Results: No Results Available Conditions: Critical Limb Ischemia Interventions: Biological: Ixmyelocel-T|Other: Vehicle Control Sponsor/Collaborators: Vericel Corporation Gender: Both Age Groups: Adult|Senior Phases: Phase 3 Enrollment: 41 Funded Bys: Industry Study Types: Interventional Study Designs: Allocation: Randomized|Endpoint Classification: Efficacy Study|Intervention Model: Parallel Assignment|Primary Purpose: Treatment|Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Other IDs: ABI 55-1009-1 First Received: November 30, 2011 Start Date: February 2012 Completion Date: March 2015 Last Updated: July 17, 2013 Last Verified: July 2013 Acronym: REVIVE Results First Received: No Study Results Posted Primary Completion Date: March 2015 Outcome Measures: Amputation free survival (AFS) at 12 months post-injection|Percent of patients with adverse events|Percent of patients with complete wound closure by Month 12|Percent of patients experiencing a major cardiac event (MACE) by Months 6, 12, and 18 URL: https://ClinicalTrials.gov/show/NCT01483898
Study 16: NCT Number: NCT00392509 Title: ALD-301 for Critical Limb Ischemia, Randomized Trial Recruitment: Completed Study Results: No Results Available Conditions: Critical Limb Ischemia|Peripheral Arterial Disease|Peripheral Vascular Disease Interventions: Procedure: ALDH-br bone marrow cells vs. mononuclear bone marrow cells Sponsor/Collaborators: Aldagen Gender: Both Age Groups: Adult|Senior Phases: Phase 1|Phase 2 Enrollment: 20 Funded Bys: Industry Study Types: Interventional Study Designs: Allocation: Randomized|Endpoint Classification: Safety/Efficacy Study|Intervention Model: Parallel Assignment|Primary Purpose: Treatment|Masking: Double Blind (Subject, Caregiver, Investigator) Other IDs: BB IND 12875 First Received: October 25, 2006 Start Date: October 2006 Completion Date: December 2008 Last Updated: May 13, 2009 Last Verified: May 2009 Acronym: CLI-001 Results First Received: No Study Results Posted Primary Completion Date: December 2008 Outcome Measures: adverse events|ankle-brachial systolic pressure index|transcutaneous oxygen value (mm Torr)|quality of life (questionnaires)|size of lower extremity ulcer(s)|peripheral nerve conduction exam|level of pain at rest (questionnaire)|limb clinical status URL: https://ClinicalTrials.gov/show/NCT00392509
Study 17: NCT Number: NCT00987363 Title: Intraarterial Infusion of Autologous Bone Marrow in Diabetic Patients With Chronic Ischemia of Lower Limbs (CLI) no Revascularization Recruitment: Completed Study Results: No Results Available Conditions: Critical Limb Ischemia (CLI)|Diabetic Foot Interventions: Other: Intraarterial infusion of autologous bone marrow cells Sponsor/Collaborators: Andalusian Initiative for Advanced Therapies - Fundaci_存n P__blica Andaluza Progreso y Salud|Iniciativa Andaluza en Terapias Avanzadas Gender: Both Age Groups: Adult|Senior Phases: Phase 1|Phase 2 Enrollment: 60 Funded Bys: Other Study Types: Interventional Study Designs: Allocation: Randomized|Endpoint Classification: Safety/Efficacy Study|Intervention Model: Parallel Assignment|Primary Purpose: Treatment|Masking: Open Label Other IDs: CMMo/ICPD/2008|2008-004064-39 First Received: September 29, 2009 Start Date: July 2009 Completion Date: March 2013 Last Updated: August 4, 2015 Last Verified: November 2014 Acronym: null Results First Received: No Study Results Posted Primary Completion Date: March 2013 Outcome Measures: Number of adverse events|AngioRNM and/or AngioTC changes|Clinically objective improvement in the ischemic limb URL: https://ClinicalTrials.gov/show/NCT00987363
Study 18: NCT Number: NCT02336646 Title: Cell Therapy With Mesenchymal Stem Cell in Ischemic Limb Disease Recruitment: Recruiting Study Results: No Results Available Conditions: Critical Limb Ischemia Interventions: Drug: Allogenic MSC|Drug: Normal saline Sponsor/Collaborators: Taiwan Bio Therapeutics Co., Ltd. Gender: Both Age Groups: Adult|Senior Phases: Phase 1 Enrollment: 18 Funded Bys: Industry Study Types: Interventional Study Designs: Allocation: Randomized|Endpoint Classification: Safety Study|Intervention Model: Single Group Assignment|Primary Purpose: Treatment|Masking: Double Blind (Subject, Investigator) Other IDs: 2012-02-070B First Received: January 8, 2015
Start Date: July 2014 Completion Date: November 2016 Last Updated: January 12, 2015 Last Verified: January 2015 Acronym: null Results First Received: No Study Results Posted Primary Completion Date: August 2016 Outcome Measures: Number of adverse events reported|Relief of the rest pain|Improvement from baseline in perfusion as measured by ankle-brachial index/ or TcPO2|Improvement from baseline in total walking distance (TWD) on a standardized treadmill test URL: https://ClinicalTrials.gov/show/NCT02336646
Study 19: NCT Number: NCT01065337 Title: Induced Wound Healing by Application of Expanded Bone Marrow Stem Cells in Diabetic Patients With Critical Limb Ischemia Recruitment: Completed Study Results: No Results Available Conditions: Diabetic Foot Interventions: Biological: tissue repair cells (TRC)|Biological: bone marrow stem cells (BMC) Sponsor/Collaborators: Ruhr University of Bochum Gender: Both Age Groups: Adult|Senior Phases: Phase 2 Enrollment: 30 Funded Bys: Other Study Types: Interventional Study Designs: Allocation: Randomized|Endpoint Classification: Safety/Efficacy Study|Intervention Model: Parallel Assignment|Primary Purpose: Treatment|Masking: Open Label Other IDs: HDZ-SBE-2004 First Received: February 8, 2010 Start Date: August 2005 Completion Date: February 2009 Last Updated: May 24, 2012 Last Verified: May 2012 Acronym: null Results First Received: No Study Results Posted Primary Completion Date: February 2009 Outcome Measures: The patient is alive, the patient has not undergone any major amputation, complete primary wound healing has been achieved, no ipsilateral relapse has occurred|Rate major amputations Rate of patients with complete ulcer healing Rate of treatment related complications Improvement of ankle brachial index (ABI) Improvement of transcutaneous oxygen partial pressure (TcPO2) Improvement of local perfusion URL: https://ClinicalTrials.gov/show/NCT01065337
Study 20: NCT Number: NCT00221143 Title: Stem Cell Study for Patients With Leg Ulcer/Gangrene Recruitment: Completed Study Results: No Results Available Conditions: Leg Pain|Ulcer|Gangrene|Ischemia|Peripheral Vascular Diseases Interventions: Genetic: Autologous peripheral blood CD34 positive cell therapy Sponsor/Collaborators: Translational Research Informatics Center, Kobe, Hyogo, Japan|Institute of Biomedical Research and Innovation, Kobe,Hyogo, Japan|Kobe City General Hospital Gender: Both Age Groups: Adult|Senior Phases: Phase 1|Phase 2 Enrollment: 15 Funded Bys: Other Study Types: Interventional Study Designs: Allocation: Non-Randomized|Endpoint Classification: Efficacy Study|Intervention Model: Single Group Assignment|Primary Purpose: Treatment|Masking: Open Label Other IDs: BRI ASO 03-01 First Received: September 13, 2005 Start Date: November 2003 Completion Date: January 2008 Last Updated: February 6, 2009 Last Verified: February 2009 Acronym: null Results First Received: No Study Results Posted Primary Completion Date: null Outcome Measures: Major amputation|Limb ischemia URL: https://ClinicalTrials.gov/show/NCT00221143
Study 21: NCT Number: NCT01584986 Title: Autologous Angiogenic Cell Precursors (ACPs) for the Treatment of Peripheral Artery Disease Recruitment: Completed Study Results: No Results Available Conditions: Critical Limb Ischemia Interventions: Biological: ACP injections Sponsor/Collaborators: Salus Ltd.|TheraVitae Ltd. Gender: null Age Groups: Child|Adult|Senior Phases: Phase 2 Enrollment: 22 Funded Bys: Industry Study Types: Interventional Study Designs: Allocation: Randomized|Endpoint Classification: Safety/Efficacy Study|Intervention Model: Parallel Assignment|Primary Purpose: Treatment|Masking: Open Label Other IDs: ACP_CLI_P01 First Received: April 24, 2012 Start Date: May 2008 Completion Date: July 2009 Last Updated: April 24, 2012 Last Verified: April 2012 Acronym: null Results First Received: No Study Results Posted Primary Completion Date: April 2009 Outcome Measures: Safety|Rest pain|Pain-free walking distance|Ulcer size|Gangrene dimension and intensity|Obtain evidence for improvement of tissue perfusion due to ACPs injection|Reduction of CLI patients hospitalization time|Decrease CLI patient amputation rate URL: https://ClinicalTrials.gov/show/NCT01584986
Study 22: NCT Number: NCT00282646 Title: Safety and Feasibility Study of Autologous Bone Marrow Cell Transplantation in Patients With Peripheral Arterial Occlusive Disease (PAOD) Recruitment: Completed Study Results: No Results Available Conditions: Arterial Occlusive Diseases Interventions: Procedure: intraarterial stem cell therapy|Other: Stem cells Sponsor/Collaborators: Johann Wolfgang Goethe University Hospitals Gender: Both Age Groups: Adult|Senior Phases: Phase 1|Phase 2 Enrollment: 40 Funded Bys: Other Study Types: Interventional Study Designs: Allocation: Randomized|Endpoint Classification: Safety/Efficacy Study|Intervention Model: Parallel Assignment|Primary Purpose: Treatment|Masking: Double Blind (Subject, Investigator) Other IDs: 2005-000968-33|PROVASA First Received: January 25, 2006
Start Date: October 2005 Completion Date: March 2011 Last Updated: August 23, 2011 Last Verified: March 2011 Acronym: null Results First Received: No Study Results Posted Primary Completion Date: October 2010 Outcome Measures: Ankle brachial index|Ulcer size|Pain|Walking distance|TCO2 URL: https://ClinicalTrials.gov/show/NCT00282646
Study 23: NCT Number: NCT01824069 Title: Treatment CLI Nonrevascularizable Lower Limb With Cell Therapy Recruitment: Recruiting Study Results: No Results Available Conditions: Nonrevascularizable Critical Ischemia of the Lower Limbs Interventions: Other: Intramuscular injection of a suspension of adult mesenchymal stem cells derived Sponsor/Collaborators: Instituto de Investigaci_存n Hospital Universitario La Paz|Hospital Universitario La Paz Gender: Both Age Groups: Adult|Senior Phases: Phase 1|Phase 2 Enrollment: 10 Funded Bys: Other Study Types: Interventional Study Designs: Endpoint Classification: Safety Study|Intervention Model: Single Group Assignment|Primary Purpose: Treatment|Masking: Open Label Other IDs: HULPVAS-2011-01|2012-000290-23 First Received: April 1, 2013 Start Date: April 2013 Completion Date: October 2014 Last Updated: April 3, 2013 Last Verified: April 2013 Acronym: HULPVAS Results First Received: No Study Results Posted Primary Completion Date: April 2014 Outcome Measures: Safety of inject mesenchymal stem cells in MMII|Quality of life of patients after treatment URL: https://ClinicalTrials.gov/show/NCT01824069
Study 24: NCT Number: NCT01446055 Title: Safety and Efficacy Study of Autologous BM-MNC Processed by Two Methods for Treating Patients With Chronic Limb Ischemia Recruitment: Not yet recruiting Study Results: No Results Available Conditions: Critical Limb Ischemia|Peripheral Arterial Disease|Buerger's Disease Interventions: Device: ResQ processed bone marrow sample|Device: Ficoll conventional cell processing method Sponsor/Collaborators: Xuanwu Hospital, Beijing|Thermogenesis Corp.|Hebei Medical University Gender: Both Age Groups: Adult|Senior Phases: Phase 1|Phase 2 Enrollment: 50 Funded Bys: Other|Industry Study Types: Interventional Study Designs: Allocation: Randomized|Endpoint Classification: Safety/Efficacy Study|Intervention Model: Parallel Assignment|Primary Purpose: Treatment|Masking: Single Blind (Subject) Other IDs: TGResQ082011 First Received: September 23, 2011 Start Date: October 2011 Completion Date: April 2013 Last Updated: October 8, 2011 Last Verified: October 2011 Acronym: null Results First Received: No Study Results Posted Primary Completion Date: April 2012 Outcome Measures: Cell treatment-related adverse event|ulcer size|rest pain score.|cold sensation score|claudication distance (m)|Resting ABI|Resting TcPO2 (mmHg)|Collateral vessel score|Amputation rate|Skin microcirculation measurement|Resting TBI URL: https://ClinicalTrials.gov/show/NCT01446055
Study 25: NCT Number: NCT00539266 Title: Autologous Bone Marrow-derived Mononuclear Cells for Therapeutic Arteriogenesis in Patients With Limb Ischemia Recruitment: Recruiting Study Results: No Results Available Conditions: Intermittent Claudication|Peripheral Vascular Diseases Interventions: Biological: bone marrow derived mononuclear cells|Biological: placebo Sponsor/Collaborators: Leiden University Medical Center Gender: Both Age Groups: Child|Adult|Senior Phases: Phase 2|Phase 3 Enrollment: 108 Funded Bys: Other Study Types: Interventional Study Designs: Allocation: Randomized|Endpoint Classification: Efficacy Study|Intervention Model: Parallel Assignment|Primary Purpose: Treatment|Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Other IDs: P07.058 First Received: October 3, 2007 Start Date: October 2007 Completion Date: October 2012 Last Updated: July 5, 2011 Last Verified: October 2007 Acronym: ABC Results First Received: No Study Results Posted Primary Completion Date: October 2012 Outcome Measures: Limb salvage/wound healing at t=6 months; Pain free walking distance|quality of life (RAND-36), pain Scores (Brief Pain Inventory), tcO2 (wrist/ankle ratio) ABI Collateral artery scores (angiogram) at t=6 months, Limb salvage/wound healing at t= 3 and 12 months, Pain free walking distance at t=3 and 12 months, URL: https://ClinicalTrials.gov/show/NCT00539266
Study 26: NCT Number: NCT01216865 Title: Umbilical Cord Mesenchymal Stem Cells Injection for Diabetic Foot Recruitment: Not yet recruiting Study Results: No Results Available Conditions: Diabetic Foot|Critical Limb Ischemia|Mesenchymal Stem Cells|Umbilical Cord Interventions: Biological: umbilical cord mesenchymal stem cells|Drug: Standard Therapy Sponsor/Collaborators: Qingdao University Gender: Both Age Groups: Adult|Senior Phases: Phase 1|Phase 2 Enrollment: 50 Funded Bys: Other Study Types: Interventional Study Designs: Allocation: Randomized|Endpoint Classification: Safety/Efficacy Study|Intervention Model: Parallel Assignment|Primary Purpose: Treatment|Masking: Open Label Other IDs: MSCDF001 First Received: October 6, 2010 Start Date: January 2011
Completion Date: July 2013 Last Updated: October 12, 2010 Last Verified: January 2009 Acronym: null Results First Received: No Study Results Posted Primary Completion Date: December 2012 Outcome Measures: Angiographic evaluation of angiogenesis at ischemic limb|Pain|Ankle-Brachial pressure index|Wound healing (wound size, wound stage)|Walking distance|Rate and extent of amputations URL: https://ClinicalTrials.gov/show/NCT01216865
Study 27: NCT Number: NCT01257776 Title: Human Adipose Derived Mesenchymal Stem Cells for Critical Limb Ischemia (CLI) in Diabetic Patients Recruitment: Completed Study Results: No Results Available Conditions: Critical Limb Ischemia (CLI)|Diabetes Interventions: Drug: Autologous adipose derived mesenchymal stem cells Sponsor/Collaborators: Andalusian Initiative for Advanced Therapies - Fundaci_存n P__blica Andaluza Progreso y Salud|Iniciativa Andaluza en Terapias Avanzadas Gender: Both Age Groups: Adult|Senior Phases: Phase 1|Phase 2 Enrollment: 33 Funded Bys: Other Study Types: Interventional Study Designs: Allocation: Randomized|Endpoint Classification: Safety/Efficacy Study|Intervention Model: Parallel Assignment|Primary Purpose: Treatment|Masking: Open Label Other IDs: CeTMAd/ICPD/2008 First Received: December 9, 2010 Start Date: December 2010 Completion Date: July 2015 Last Updated: August 4, 2015 Last Verified: November 2014 Acronym: null Results First Received: No Study Results Posted Primary Completion Date: February 2013 Outcome Measures: Angiographic assessment of neovasculogenesis (angiogenesis plus arteriogenesis)|Major adverse event (death, target limb amputation)|Ankle Brachial Index|University of Texas Classification at target limb URL: https://ClinicalTrials.gov/show/NCT01257776
Study 28: NCT Number: NCT00468000 Title: Use of Ixmyelocel-T (Formerly Vascular Repair Cells [VRC]) in Patients With Peripheral Arterial Disease to Treat Critical Limb Ischemia Recruitment: Completed Study Results: No Results Available Conditions: Peripheral Arterial Disease Interventions: Biological: autologous bone marrow cells|Biological: electrolyte solution (without cells) Sponsor/Collaborators: Vericel Corporation Gender: Both Age Groups: Adult|Senior Phases: Phase 2 Enrollment: 86 Funded Bys: Industry Study Types: Interventional Study Designs: Allocation: Randomized|Endpoint Classification: Safety/Efficacy Study|Intervention Model: Parallel Assignment|Primary Purpose: Treatment|Masking: Double Blind (Subject, Investigator) Other IDs: ABI-55-0610-1 First Received: April 30, 2007 Start Date: April 2007 Completion Date: March 2011 Last Updated: October 1, 2012 Last Verified: October 2012 Acronym: RESTORE-CLI Results First Received: No Study Results Posted Primary Completion Date: March 2011 Outcome Measures: Safety of TRCs in patients with CLI(key safety parameters include vital signs, physical exams, laboratory results, assessment of aspiration and injection sites, adverse events, major amputations, wounds presence(size and grading using the Wagner scale)|Composite efficacy endpoint assessing time to treatment failure(failure defined as major amputation, doubling of wound size, and new gangrene)|Percentage of patients failing treatment|Time to major amputation|Percentage of patients undergoing major amputation|Incidence of revascularization interventions throughout duration of study|Incidence of bypass surgery for patients throughout duration of study|Healing of all wounds in the target limb|Ankle and/or toe pressure and ankle brachial pressure index and/or toe brachial index|Pain, as measured by visual analog scale(VAS)|The King's College Vascular Quality of Life Questionnaire|Walking distance as measured by six-minute walk test(with or without walking device)|Concurrent Meds for trends URL: https://ClinicalTrials.gov/show/NCT00468000
Study 29: NCT Number: NCT02099500 Title: Autologous Adipose-Derived Stromal Cell Delivered Via Intramuscular Injections for the Treatment of Critical Limb Ischemia Recruitment: Recruiting Study Results: No Results Available Conditions: Critical Limb Ischemia Interventions: Procedure: Liposuction|Other: Stem Cell Injection Sponsor/Collaborators: Ageless Regenerative Institute Gender: Both Age Groups: Adult|Senior Phases: Phase 1|Phase 2 Enrollment: 200 Funded Bys: Industry Study Types: Interventional Study Designs: Allocation: Non-Randomized|Endpoint Classification: Safety/Efficacy Study|Intervention Model: Single Group Assignment|Primary Purpose: Treatment|Masking: Open Label Other IDs: ADI-US-CLIN-001 First Received: March 19, 2014 Start Date: March 2014 Completion Date: June 2016 Last Updated: July 10, 2014 Last Verified: July 2014 Acronym: null Results First Received: No Study Results Posted Primary Completion Date: April 2016 Outcome Measures: Improvement from baseline in perfusion as measured by ankle-brachial index and collateral artery number|Number of adverse events reported|Improvement from baseline in improvement or resolution of ulcer or gangrene|Limb Salvage URL: https://ClinicalTrials.gov/show/NCT02099500
Study 30: NCT Number: NCT01833585 Title: Treatment of Chronic Critical Limb Ischemia With G-CSF-mobilized Autologous Peripheral Blood Mononuclear Cells Recruitment: Recruiting Study Results: No Results Available Conditions: Critical Limb Ischemia|Atherosclerosis|Ischemic Ulcer|Gangrene Interventions: Biological: Peripheral blood mononuclear cell Sponsor/Collaborators: Mahidol University Gender: Both Age Groups: Adult|Senior Phases: Phase 3 Enrollment: 10 Funded Bys: Other Study Types: Interventional Study Designs: Endpoint Classification: Safety/Efficacy Study|Intervention Model: Single Group Assignment|Primary Purpose: Treatment|Masking: Open Label Other IDs: SIRIRAJR015533013 First Received: April 9, 2013
Start Date: April 2013 Completion Date: December 2014 Last Updated: April 14, 2013 Last Verified: April 2013 Acronym: null Results First Received: No Study Results Posted Primary Completion Date: December 2014 Outcome Measures: Number of patients without major amputation after mononuclear cell injection URL: https://ClinicalTrials.gov/show/NCT01833585
Study 31: NCT Number: NCT01386216 Title: Safety Study of Bone Marrow Cell Concentrate Prepared Using the Magellan System to Treat Critical Limb Ischemia (CLI) Recruitment: Active, not recruiting Study Results: No Results Available Conditions: Critical Limb Ischemia (CLI)|Peripheral Vascular Disease (PVD) Interventions: Device: Magellan_¨ Sponsor/Collaborators: Arteriocyte, Inc. Gender: Both Age Groups: Adult|Senior Phases: Phase 1 Enrollment: 20 Funded Bys: Industry Study Types: Interventional Study Designs: Allocation: Non-Randomized|Endpoint Classification: Safety Study|Intervention Model: Single Group Assignment|Primary Purpose: Treatment|Masking: Open Label Other IDs: ART 10-001 First Received: June 29, 2011 Start Date: April 2011 Completion Date: September 2015 Last Updated: July 8, 2014 Last Verified: July 2014 Acronym: CLI Results First Received: No Study Results Posted Primary Completion Date: July 2015 Outcome Measures: Time to treatment failure or death|Perfusion and Quality of Life measurements URL: https://ClinicalTrials.gov/show/NCT01386216
Study 32: NCT Number: NCT01745744 Title: Application of Cell Regeneration Therapy With Mesenchymal Stem Cells From Adipose Tissue in Critical Chronic Ischemic Syndrome of Lower Limbs (CLI) in Nondiabetic Patients. Recruitment: Active, not recruiting Study Results: No Results Available Conditions: Critical Limb Ischemia Interventions: Other: Mesenchymal stem cells from adipose tissue Sponsor/Collaborators: Andalusian Initiative for Advanced Therapies - Fundaci_¸n P__blica Andaluza Progreso y Salud|Iniciativa Andaluza en Terapias Avanzadas Gender: Both Age Groups: Adult|Senior Phases: Phase 1|Phase 2 Enrollment: 33 Funded Bys: Other Study Types: Interventional Study Designs: Allocation: Randomized|Endpoint Classification: Safety/Efficacy Study|Intervention Model: Parallel Assignment|Primary Purpose: Treatment|Masking: Open Label Other IDs: CeTMAd/ICC/2009|2009-013554-32 First Received: December 3, 2012 Start Date: February 2011 Completion Date: July 2015 Last Updated: June 12, 2015 Last Verified: November 2014 Acronym: null Results First Received: No Study Results Posted Primary Completion Date: July 2013 Outcome Measures: Number of adverse events and serious adverse events|Evolution of chronic critical ischemia URL: https://ClinicalTrials.gov/show/NCT01745744
Study 33: NCT Number: NCT02089828 Title: Purified CD34+ Cells Versus Peripheral Blood Mononuclear Cells in Treatment of Critical Limb Ischemia Recruitment: Recruiting Study Results: No Results Available Conditions: Thromboangiitis Obliterans|Arteritis|Peripheral Arterial Disease Interventions: Other: autologous purified CD34+ cells|Other: autologous peripheral blood mononuclear cells Sponsor/Collaborators: Shanghai Zhongshan Hospital Gender: Both Age Groups: Adult|Senior Phases: Enrollment: 50 Funded Bys: Other Study Types: Interventional Study Designs: Allocation: Randomized|Endpoint Classification: Efficacy Study|Intervention Model: Parallel Assignment|Primary Purpose: Treatment|Masking: Single Blind (Subject) Other IDs: B2014-021 First Received: March 14, 2014 Start Date: March 2014 Completion Date: December 2018 Last Updated: March 17, 2014 Last Verified: February 2014 Acronym: null Results First Received: No Study Results Posted Primary Completion Date: December 2017 Outcome Measures: major-amputation-free survival rate|improvement on transcutaneous partial oxygen pressure URL: https://ClinicalTrials.gov/show/NCT02089828
Study 34: NCT Number: NCT00951210 Title: Safety of Intramuscular Injections (IM) of Allogeneic PLX-PAD Cells for the Treatment of Critical Limb Ischemia (CLI) Recruitment: Completed Study Results: No Results Available Conditions: Peripheral Artery Disease|Peripheral Vascular Disease|Critical Limb Ischemia Interventions: Biological: PLX-PAD Sponsor/Collaborators: Pluristem Ltd. Gender: Both Age Groups: Adult|Senior Phases: Phase 1 Enrollment: 12 Funded Bys: Industry Study Types: Interventional Study Designs: Allocation: Non-Randomized|Endpoint Classification: Safety Study|Intervention Model: Factorial Assignment|Primary Purpose: Treatment|Masking: Open Label Other IDs: 1202-2 First Received: August 3, 2009 Start Date: August 2009 Completion Date: October 2011 Last Updated: May 24, 2015
Last Verified: November 2011 Acronym: null Results First Received: No Study Results Posted Primary Completion Date: January 2011 Outcome Measures: Adverse events; Amputation incidence, Death incidence & Rehospitalization incidence|Immunological reaction URL: https://ClinicalTrials.gov/show/NCT00951210
Study 35: NCT Number: NCT00919958 Title: Safety of Intramuscular Injection of Allogeneic PLX-PAD Cells for the Treatment of Critical Limb Ischemia Recruitment: Completed Study Results: No Results Available Conditions: Peripheral Artery Disease|Peripheral Vascular Disease|Critical Limb Ischemia Interventions: Biological: PLX-PAD IM injection Sponsor/Collaborators: Pluristem Ltd. Gender: Both Age Groups: Adult|Senior Phases: Phase 1 Enrollment: 15 Funded Bys: Industry Study Types: Interventional Study Designs: Allocation: Non-Randomized|Endpoint Classification: Safety Study|Intervention Model: Factorial Assignment|Primary Purpose: Treatment|Masking: Open Label Other IDs: PLX-PAD 1202-1 First Received: June 10, 2009 Start Date: June 2009 Completion Date: June 2012 Last Updated: June 17, 2012 Last Verified: June 2012 Acronym: null Results First Received: No Study Results Posted Primary Completion Date: June 2012 Outcome Measures: Adverse events, Safety laboratory values and ECG findings|Immunological reaction|Tumorigenesis URL: https://ClinicalTrials.gov/show/NCT00919958
Study 36: NCT Number: NCT01480414 Title: Side Effects of 4 Times Bone Marrow Mono Nuclear Transplantation in Patients With Ischemic Lower Limb Recruitment: Completed Study Results: No Results Available Conditions: Ischemic Ulcer Interventions: Biological: 4times injection|Biological: stem cell transplantation Sponsor/Collaborators: Royan Institute Gender: Both Age Groups: Adult Phases: Phase 1|Phase 2 Enrollment: 20 Funded Bys: Other Study Types: Interventional Study Designs: Allocation: Randomized|Endpoint Classification: Safety Study|Intervention Model: Parallel Assignment|Primary Purpose: Treatment|Masking: Open Label Other IDs: Royan-PVD-002 First Received: November 23, 2011 Start Date: September 2010 Completion Date: May 2012 Last Updated: December 25, 2012 Last Verified: July 2010 Acronym: null Results First Received: No Study Results Posted Primary Completion Date: April 2012 Outcome Measures: side effects|PFWD|ABI|size and depth of ulcer|Amputation URL: https://ClinicalTrials.gov/show/NCT01480414
Study 37: NCT Number: NCT01232673 Title: Autologous Bone Marrow Stem Cell Transfer in Patients With Chronical Critical Limb Ischemia and Diabetic Foot Recruitment: Completed Study Results: No Results Available Conditions: Critical Limb Ischemia Interventions: Procedure: BMAC application in Critical Limb Ischemia Sponsor/Collaborators: University Hospital Ostrava Gender: Both Age Groups: Adult|Senior Phases: Phase 2 Enrollment: 96 Funded Bys: Other Study Types: Interventional Study Designs: Allocation: Randomized|Endpoint Classification: Safety/Efficacy Study|Intervention Model: Parallel Assignment|Primary Purpose: Treatment|Masking: Open Label Other IDs: FNO-99/OVZ/08/006-Dot First Received: November 1, 2010 Start Date: October 2008 Completion Date: December 2010 Last Updated: March 21, 2013 Last Verified: March 2013 Acronym: null Results First Received: No Study Results Posted Primary Completion Date: November 2009 Outcome Measures: Major limb amputation|Tissue perfusion measurements URL: https://ClinicalTrials.gov/show/NCT01232673
Study 38: NCT Number: NCT00523731 Title: ACPs in Severe PAD/CLI by Direct Intramuscular Injection Recruitment: Completed Study Results: No Results Available Conditions: Peripheral Arterial Disease|Critical Limb Ischemia Interventions: Procedure: Angiogenic Cell Precursors (ACPs) or Vescell TM Sponsor/Collaborators: TheraVitae Ltd. Gender: Both Age Groups: Adult|Senior Phases: Phase 1 Enrollment: 6 Funded Bys: Industry Study Types: Interventional Study Designs: Allocation: Non-Randomized|Endpoint Classification: Safety/Efficacy Study|Intervention Model: Single Group Assignment|Primary Purpose: Treatment|Masking: Open Label Other IDs: TV-003|ACPs-CLI First Received: August 30, 2007 Start Date: January 2006 Completion Date: March 2007 Last Updated: August 30, 2007 Last Verified: February 2007 Acronym: null Results First Received: No Study Results Posted
Primary Completion Date: null Outcome Measures: Safety|Evaluate the safety of ACPs intramuscular injection|Efficacy|Attenuate CLI patients symptoms as|Rest pain|Pain-free walking distance|Ulcer size|Gangrene dimension and intensity|Obtain evidence for improvement of tissue perfusion due to ACPs injection|Reduction of CLI patients hospitalization time.|Decrease CLI patient amputation rate. URL: https://ClinicalTrials.gov/show/NCT00523731
Study 39: NCT Number: NCT02454231 Title: Monocentric Trial: Stem Cell Emergency Life Threatening Limbs Arteriopathy (SCELTA) Recruitment: Recruiting Study Results: No Results Available Conditions: Critical Limb Ischemia Interventions: Biological: Transplantation of circulating CD14+CD34+cells|Biological: Transplantation of BM MNC Sponsor/Collaborators: University of Florence|Tuscany Region Gender: Both Age Groups: Adult|Senior Phases: Phase 2|Phase 3 Enrollment: 38 Funded Bys: Other Study Types: Interventional Study Designs: Allocation: Randomized|Endpoint Classification: Safety/Efficacy Study|Intervention Model: Parallel Assignment|Primary Purpose: Treatment|Masking: Open Label Other IDs: UFlorence First Received: May 19, 2015 Start Date: September 2009 Completion Date: October 2015 Last Updated: May 26, 2015 Last Verified: May 2015 Acronym: SCELTA Results First Received: No Study Results Posted Primary Completion Date: May 2015 Outcome Measures: Safety as measured by evaluation of any adverse event temporary correlated with the treatment|Changes in ischemic leg perfusion from baseline|Improvement of Mean values of the transcutaneous partial oxygen pressure (TCP02)|Improvement of mean values of ankle brachial pressure index (ABI)|Improvement of vessel anatomical status|Improvement of leg perfusion|Quality of life Improvement|improvement of rest pain|Improvement of trophic limb lesions|Reduction of numbers of major amputation (amputation free survival )|improvement of microvascular anatomy URL: https://ClinicalTrials.gov/show/NCT02454231
Study 40: NCT Number: NCT02234778 Title: Evaluation of the Tissue Genesis_ﾂｨ Icellator Cell Isolation System_ﾄダ to Treat Critical Limb Ischemia Recruitment: Recruiting Study Results: No Results Available Conditions: Critical Limb Ischemia Interventions: Device: TGI SVF material via intramuscular injection Sponsor/Collaborators: Tissue Genesis, Inc.|U.S. Army Medical Research and Materiel Command Gender: Both Age Groups: Adult|Senior Phases: Enrollment: 20 Funded Bys: Industry|U.S. Fed Study Types: Interventional Study Designs: Endpoint Classification: Safety/Efficacy Study|Intervention Model: Single Group Assignment|Primary Purpose: Treatment|Masking: Open Label Other IDs: TGI-002-01-2013 First Received: September 4, 2014 Start Date: August 2014 Completion Date: March 2016 Last Updated: April 1, 2015 Last Verified: April 2015 Acronym: CLI-DI Results First Received: No Study Results Posted Primary Completion Date: September 2015 Outcome Measures: Amputation-Free Survival URL: https://ClinicalTrials.gov/show/NCT02234778
Study 41: NCT Number: NCT01019681 Title: Efficacy and Safety of Umbilical Cord Blood Injection for Critical Limb Ischemia Recruitment: Terminated Study Results: No Results Available Conditions: Critical Limb Ischemia Interventions: Biological: Cord blood stem cell injection Sponsor/Collaborators: Richard Burt, MD|Northwestern University Gender: Both Age Groups: Adult|Senior Phases: Phase 1 Enrollment: 1 Funded Bys: Other Study Types: Interventional Study Designs: Endpoint Classification: Safety/Efficacy Study|Intervention Model: Single Group Assignment|Primary Purpose: Treatment|Masking: Open Label Other IDs: PVD.Cord.Blood.2008 First Received: November 19, 2009 Start Date: November 2009 Completion Date: January 2014 Last Updated: January 31, 2014 Last Verified: January 2014 Acronym: null Results First Received: No Study Results Posted Primary Completion Date: January 2014 Outcome Measures: Ankle brachial index (ABI), a 15% increase will be considered improvement|Healing of ischemic ulcers|Decreased pain level as reported by the patient|SF-36 quality of life (QOL)|Walking Impairment Questionnaire|Increase in pain free ambulation time on treadmill by more than 25%|Increase in four meter walk or six minute walk by more than 25% URL: https://ClinicalTrials.gov/show/NCT01019681
Study 42: NCT Number: NCT02145897 Title: To Evaluate the Safety and Efficacy of IM and IV Administration of Autologous ADMSCs for Treatment of CLI Recruitment: Recruiting Study Results: No Results Available Conditions: Critical Limb Ischemia Interventions: Biological: Autologous Stromal Vascular Fraction (SVF)|Biological: Autologous Adipose Derieved MSCs|Other: Control Sponsor/Collaborators: Kasiak Research Pvt. Ltd. Gender: Both Age Groups: Adult Phases: Phase 1|Phase 2 Enrollment: 60 Funded Bys: Industry Study Types: Interventional Study Designs: Allocation: Randomized|Endpoint Classification: Safety/Efficacy Study|Intervention Model: Parallel Assignment|Primary Purpose: Treatment|Masking: Open Label Other IDs: KRPL/CLI/11-12/001 First Received: May 8, 2014 Start Date: August 2014 Completion Date: null Last Updated: May 20, 2014 Last Verified: May 2014
Acronym: null Results First Received: No Study Results Posted Primary Completion Date: August 2015 Outcome Measures: To assess the safety|To assess the efficacy URL: https://ClinicalTrials.gov/show/NCT02145897
Study 43: NCT Number: NCT01245335 Title: Bone Marrow Aspirate Concentrate (BMAC) for Treatment of Critical Limb Ischemia (CLI) Recruitment: Active, not recruiting Study Results: No Results Available Conditions: Critical Limb Ischemia Interventions: Device: BMAC injection|Device: Placebo injection Sponsor/Collaborators: Harvest Technologies Gender: Both Age Groups: Adult|Senior Phases: Phase 3 Enrollment: 210 Funded Bys: Industry Study Types: Interventional Study Designs: Allocation: Randomized|Endpoint Classification: Safety/Efficacy Study|Intervention Model: Parallel Assignment|Primary Purpose: Treatment|Masking: Double Blind (Subject, Investigator) Other IDs: CLI-2011-1 First Received: November 18, 2010 Start Date: May 2011 Completion Date: November 2016 Last Updated: August 19, 2015 Last Verified: August 2015 Acronym: null Results First Received: No Study Results Posted Primary Completion Date: August 2015 Outcome Measures: Amputation Free Survival|Change In Rutherford Classification|Change in Pain URL: https://ClinicalTrials.gov/show/NCT01245335
Study 44: NCT Number: NCT01472289 Title: Safety and Efficacy of Autologous Bone Marrow Mononuclear Cells in Patients With Severe Critical Limb Ischemia Recruitment: Active, not recruiting Study Results: No Results Available Conditions: Critical Limb Ischemia Interventions: Other: Autologous Bone Marrow Mononuclear cells Sponsor/Collaborators: TotipotentSC Scientific Product Pvt. Ltd.|Thermogenesis Corp. Gender: Both Age Groups: Adult Phases: Phase 1|Phase 2 Enrollment: 15 Funded Bys: Industry Study Types: Interventional Study Designs: Endpoint Classification: Safety/Efficacy Study|Intervention Model: Single Group Assignment|Primary Purpose: Treatment|Masking: Open Label Other IDs: TPSC/POC/BMSC/CLI/1.1|050343290-0702201132855389 First Received: July 18, 2011 Start Date: February 2011 Completion Date: November 2013 Last Updated: September 2, 2013 Last Verified: September 2013 Acronym: null Results First Received: No Study Results Posted Primary Completion Date: September 2013 Outcome Measures: Number of adverse events as a measure of Safety and limb salvage|Disease severity|Change in Rest Pain|Ulcer Healing|Assessment of Co-morbidity URL: https://ClinicalTrials.gov/show/NCT01472289
Study 45: NCT Number: NCT01837264 Title: Phase I, Arteriocyte Magellan MAR01 Therapy - Compartment Syndrome and Battlefield Trauma Recruitment: Recruiting Study Results: No Results Available Conditions: Compartment Syndrome Interventions: Device: Magellan_¨ Sponsor/Collaborators: Arteriocyte, Inc. Gender: Both Age Groups: Adult Phases: Phase 1 Enrollment: 30 Funded Bys: Industry Study Types: Interventional Study Designs: Endpoint Classification: Safety Study|Intervention Model: Single Group Assignment|Primary Purpose: Treatment|Masking: Open Label Other IDs: ART-11-003 First Received: April 17, 2013 Start Date: January 2013 Completion Date: September 2016 Last Updated: November 19, 2014 Last Verified: November 2014 Acronym: Magellan MAR01 Results First Received: No Study Results Posted Primary Completion Date: September 2015 Outcome Measures: Time to treatment failure or death|Perfusion and quality of life measurements URL: https://ClinicalTrials.gov/show/NCT01837264
Study 46: NCT Number: NCT01867190 Title: Study to Assess Efficacy and Safety of Bone Marrow Derived Stem Cells in Patients With Critical Limb Ischemia Recruitment: Recruiting Study Results: No Results Available Conditions: Critical Limb Ischemia Interventions: Biological: ASCT01 (Autologous Stem Cell Transplantation) Sponsor/Collaborators: Lifecells, LLC. Gender: Both Age Groups: Adult|Senior Phases: Phase 1|Phase 2 Enrollment: 24 Funded Bys: Industry Study Types: Interventional Study Designs: Endpoint Classification: Safety/Efficacy Study|Intervention Model: Single Group Assignment|Primary Purpose: Treatment|Masking: Open Label Other IDs: IND 15069 First Received: May 29, 2013 Start Date: May 2013 Completion Date: June 2015 Last Updated: September 12, 2014 Last Verified: September 2014 Acronym: CLI Results First Received: No Study Results Posted Primary Completion Date: December 2014
Outcome Measures: To assess the efficacy and safety of intra-arterial infusion and intramuscular injection of ASCT01 on the combined primary endpoint of major amputation (above the ankle) or persisting critical limb ischemia (no clinical or perfusion improvement). URL: https://ClinicalTrials.gov/show/NCT01867190
Study 47: NCT Number: NCT01758874 Title: Study to Explore the Effect of Lowering Blood Viscosity in Patients With Treatment-resistant Critical Limb Ischemia Recruitment: Completed Study Results: No Results Available Conditions: Critical Limb Ischemia Interventions: Procedure: phlebotomy Sponsor/Collaborators: Seoul Veterans Hospital Gender: Male Age Groups: Child|Adult|Senior Phases: Phase 2 Enrollment: 20 Funded Bys: Other Study Types: Interventional Study Designs: Allocation: Non-Randomized|Endpoint Classification: Safety/Efficacy Study|Intervention Model: Parallel Assignment|Primary Purpose: Treatment|Masking: Open Label Other IDs: 2006-19 First Received: May 14, 2012 Start Date: September 2006 Completion Date: April 2012 Last Updated: December 27, 2012 Last Verified: December 2012 Acronym: CLI-PH Results First Received: No Study Results Posted Primary Completion Date: April 2007 Outcome Measures: Major amputation rate (limb salvage rate)|Time-to-major amputation|Mortality rate|Blood viscosity measurements URL: https://ClinicalTrials.gov/show/NCT01758874
Study 48: NCT Number: NCT00488020 Title: Stem Cells for Treating Critical Ischemia Recruitment: Recruiting Study Results: No Results Available Conditions: Critical Limb Ischemia|Ischemic Ulcers Interventions: Procedure: stem cells transplant Sponsor/Collaborators: Instituto de Molestias Cardiovasculares Gender: Both Age Groups: Adult|Senior Phases: Phase 1 Enrollment: 10 Funded Bys: Other Study Types: Interventional Study Designs: Endpoint Classification: Safety/Efficacy Study|Intervention Model: Single Group Assignment|Primary Purpose: Treatment|Masking: Open Label Other IDs: imc1 First Received: June 15, 2007 Start Date: April 2006 Completion Date: June 2007 Last Updated: June 12, 2008 Last Verified: June 2007 Acronym: null Results First Received: No Study Results Posted Primary Completion Date: null Outcome Measures: Suppress pain and heal ischemic ulcers|improve quality of life URL: https://ClinicalTrials.gov/show/NCT00488020
Study 49: NCT Number: NCT00595257 Title: Feasability Study of Autologous Bone Marrow Aspirate Concentrate for Treatment of CLI Recruitment: Completed Study Results: No Results Available Conditions: Arterial Occlusive Diseases Interventions: Device: centrifuge, laboratory, tabletop (SmartPReP2 BMAC System) Sponsor/Collaborators: Harvest Technologies Gender: Both Age Groups: Adult|Senior Phases: Phase 1|Phase 2 Enrollment: 60 Funded Bys: Industry Study Types: Interventional Study Designs: Allocation: Randomized|Intervention Model: Parallel Assignment|Primary Purpose: Treatment|Masking: Open Label Other IDs: TriCell/CT/IND-001 First Received: December 19, 2007 Start Date: December 2007 Completion Date: April 2010 Last Updated: March 8, 2012 Last Verified: March 2012 Acronym: null Results First Received: No Study Results Posted Primary Completion Date: October 2009 Outcome Measures: avoid amputation|measurement of hemodynamic response URL: https://ClinicalTrials.gov/show/NCT00595257
Study 50: NCT Number: NCT01686139 Title: Safety Study of Stem Cells Treatment in Diabetic Foot Ulcers Recruitment: Not yet recruiting Study Results: No Results Available Conditions: Type I Diabetes Mellitus With Ulcer|Type II Diabetes Mellitus With Ulcer Interventions: Biological: ABMD-MSC Sponsor/Collaborators: Sheba Medical Center Gender: Both Age Groups: Adult|Senior Phases: Phase 1|Phase 2 Enrollment: 10 Funded Bys: Other Study Types: Interventional Study Designs: Endpoint Classification: Safety/Efficacy Study|Intervention Model: Single Group Assignment|Primary Purpose: Treatment|Masking: Open Label Other IDs: SHEBA-11-8802-IS-SMC First Received: September 12, 2012 Start Date: May 2014 Completion Date: null Last Updated: January 29, 2014 Last Verified: January 2014 Acronym: null Results First Received: No Study Results Posted Primary Completion Date: February 2015 Outcome Measures: Frequency of Adverse Events|Healing of all wounds in the target limb URL: https://ClinicalTrials.gov/show/NCT01686139
Study 51: NCT Number: NCT00913900 Title: Safety Study of Adult Stem Cells to Treat Patients With Severe Leg Artery Disease Recruitment: Terminated Study Results: No Results Available Conditions: Critical Limb Ischemia|Arterial Occlusive Disease|Vascular Diseases Interventions: Biological: autologous CD133+ cells Sponsor/Collaborators: University of Wisconsin, Madison Gender: Both Age Groups: Adult|Senior Phases: Phase 1 Enrollment: 10 Funded Bys: Other Study Types: Interventional Study Designs: Allocation: Randomized|Endpoint Classification: Safety Study|Intervention Model: Parallel Assignment|Primary Purpose: Treatment|Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Other IDs: H-2009-0008 First Received: June 2, 2009 Start Date: May 2009 Completion Date: December 2013 Last Updated: December 4, 2014 Last Verified: December 2014 Acronym: SCRIPT-CLI Results First Received: No Study Results Posted Primary Completion Date: December 2013 Outcome Measures: Death or amputation|Vascular hemodynamics and function URL: https://ClinicalTrials.gov/show/NCT00913900
Study 52: NCT Number: NCT02474121 Title: Safety and Efficacy of Autologous Concentrated Bone Marrow Aspirate for Critical Limb Ischemia - Continued Access Recruitment: Temporarily not available Study Results: No Results Available Conditions: Peripheral Arterial Disease|Peripheral Vascular Diseases|Critical Limb Ischemia Interventions: Device: Bone marrow concentration device Sponsor/Collaborators: Biomet, Inc. Gender: Both Age Groups: Adult|Senior Phases: Enrollment: null Funded Bys: Industry Study Types: Expanded Access Study Designs: Other IDs: BB-IDE 13996 (CA) First Received: June 15, 2015 Start Date: null Completion Date: null Last Updated: June 15, 2015 Last Verified: June 2015 Acronym: MOBILE-CA Results First Received: No Study Results Posted Primary Completion Date: null Outcome Measures: URL: https://ClinicalTrials.gov/show/NCT02474121
Study 53: NCT Number: NCT00955669 Title: Comparison of Autologous Mesenchymal Stem Cells and Mononuclear Cells on Diabetic Critical Limb Ischemia and Foot Ulcer Recruitment: Completed Study Results: No Results Available Conditions: Autologous Transplantation|Diabetic Foot Interventions: Biological: Symptoms and Objective Examination Sponsor/Collaborators: Third Military Medical University Gender: Both Age Groups: Adult|Senior Phases: Phase 1 Enrollment: 40 Funded Bys: Other Study Types: Interventional Study Designs: Allocation: Randomized|Endpoint Classification: Safety/Efficacy Study|Intervention Model: Parallel Assignment|Primary Purpose: Treatment|Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Other IDs: ldb2008101 First Received: August 4, 2009 Start Date: August 2009 Completion Date: August 2010 Last Updated: November 30, 2010 Last Verified: November 2010 Acronym: null Results First Received: No Study Results Posted Primary Completion Date: August 2010 Outcome Measures: Magnetic resonance angiography URL: https://ClinicalTrials.gov/show/NCT00955669
Study 54: NCT Number: NCT00434616 Title: Autologous Bone Marrow Stem Cell Transplantation for Critical, Limb-threatening Ischemia Recruitment: Active, not recruiting Study Results: No Results Available Conditions: Peripheral Vascular Disease|Diabetic Foot|Peripheral Arterial Occlusive Disease|Leg Ulcer|Gangrene|Ischemia Interventions: Procedure: Autologous bone marrow cell concentrate transplantation|Biological: saline injection Sponsor/Collaborators: Franziskus-Krankenhaus|SRH Klinikum Karlsbad-Langensteinbach|Stiftungsklinikum Boppard|Krankenhaus der Barmherzigen Br_Âťder Trier Gender: Both Age Groups: Adult|Senior Phases: Phase 2|Phase 3 Enrollment: 90 Funded Bys: Other Study Types: Interventional Study Designs: Allocation: Randomized|Endpoint Classification: Safety/Efficacy Study|Intervention Model: Parallel Assignment|Primary Purpose: Treatment|Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Other IDs: 2006-001825-24|FKH 200 First Received: February 9, 2007 Start Date: April 2007 Completion Date: July 2011 Last Updated: April 5, 2011 Last Verified: April 2011 Acronym: BONMOT Results First Received: No Study Results Posted Primary Completion Date: April 2011 Outcome Measures: Major amputation of the index limb or persisting, unchanged critical limb ischemia|Wound healing (wound size, wound stage)|Pain and analgesics use|Rutherford grade and stage|Walking distance (treadmill) if possible|Quality of life (EQ-5D Questionnaire)|Transcutaneous oxygen pressure (TcpO2), ABI, absolute ankle perfusion pressure|Collateral artery number as judged by contrast angiography after 3 months|Rate and extent of minor (below the ankle) amputations|survival without amputation URL: https://ClinicalTrials.gov/show/NCT00434616
Study 55: NCT Number: NCT00498069 Title: Study of Autologous Bone Marrow Concentrate for the Treatment of Critical Limb Ischemia (CLI) Recruitment: Completed Study Results: No Results Available Conditions: Ischemia Interventions: Device: Harvest Smartprep2 BMAC System|Device: SmartPReP2 BMAC System|Biological: placebo Sponsor/Collaborators: Harvest Technologies Gender: Both Age Groups: Adult|Senior Phases: Enrollment: 48 Funded Bys: Industry Study Types: Interventional Study Designs: Allocation: Randomized|Endpoint Classification: Safety/Efficacy Study|Intervention Model: Parallel Assignment|Primary Purpose: Treatment|Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Other IDs: 2007-1 First Received: July 5, 2007 Start Date: November 2007 Completion Date: March 2015 Last Updated: March 17, 2015 Last Verified: June 2014 Acronym: null Results First Received: No Study Results Posted Primary Completion Date: March 2015 Outcome Measures: To be determined by data from this feasibility study URL: https://ClinicalTrials.gov/show/NCT00498069
Study 56: NCT Number: NCT01456819 Title: Intramuscular Mononuclear Cells and Mesenchymal Stem Cells Transplantation to Treat Chronic Critical Limb Ischemia Recruitment: Recruiting Study Results: No Results Available Conditions: Critical Limb Ischemia Interventions: Biological: Mononuclear and mesenchymal stem cells|Biological: Mononuclear cells Sponsor/Collaborators: National University of Malaysia|Cytopeutics Sdn Bhd Gender: Both Age Groups: Adult|Senior Phases: Phase 2 Enrollment: 50 Funded Bys: Other Study Types: Interventional Study Designs: Allocation: Randomized|Endpoint Classification: Efficacy Study|Intervention Model: Parallel Assignment|Primary Purpose: Treatment|Masking: Single Blind (Outcomes Assessor) Other IDs: FF-113-2011|NMRR-11-904-9763 First Received: October 4, 2011 Start Date: March 2011 Completion Date: February 2016 Last Updated: April 9, 2015 Last Verified: April 2015 Acronym: null Results First Received: No Study Results Posted Primary Completion Date: December 2015 Outcome Measures: Change in angiogenesis|Change in ulcer size|Visual Analog Score|Exercise Treadmill Test|Improvement in vascularity and blood supply URL: https://ClinicalTrials.gov/show/NCT01456819
Study 57: NCT Number: NCT01269580 Title: Diabetic Foot and Vascular Progenitor Cells Recruitment: Active, not recruiting Study Results: No Results Available Conditions: Diabetes|Critical Limb Ischemia Interventions: Sponsor/Collaborators: IRCCS Multimedica Gender: Both Age Groups: Adult|Senior Phases: Enrollment: 122 Funded Bys: Other Study Types: Observational Study Designs: Observational Model: Case Control|Time Perspective: Prospective Other IDs: 20/2008_Cardiovascolare First Received: January 3, 2011 Start Date: February 2009 Completion Date: June 2015 Last Updated: August 7, 2013 Last Verified: August 2013 Acronym: null Results First Received: No Study Results Posted Primary Completion Date: June 2013 Outcome Measures: post revascularization cardiovascualr mortality|post revascularization amputation URL: https://ClinicalTrials.gov/show/NCT01269580
Study 58: NCT Number: NCT00883870 Title: Mesenchymal Stem Cells in Critical Limb Ischemia Recruitment: Completed Study Results: No Results Available Conditions: Critical Limb Ischemia Interventions: Drug: mesenchymal stem cells|Drug: Plasmalyte A Sponsor/Collaborators: Stempeutics Research Pvt Ltd Gender: Both Age Groups: Adult Phases: Phase 1|Phase 2 Enrollment: 20 Funded Bys: Industry Study Types: Interventional Study Designs: Allocation: Randomized|Endpoint Classification: Safety/Efficacy Study|Intervention Model: Parallel Assignment|Primary Purpose: Treatment|Masking: Double Blind (Subject, Caregiver, Investigator) Other IDs: SRPL/CLI/07-08/001 First Received: April 17, 2009 Start Date: April 2009 Completion Date: August 2012 Last Updated: March 4, 2013 Last Verified: March 2013 Acronym: null Results First Received: No Study Results Posted Primary Completion Date: February 2010 Outcome Measures: AE and symptomatic relief|Increase in transcutaneous partial oxygen pressure (TcPO2) and Ankle brachial pressure index (ABPI) - measured by Doppler URL: https://ClinicalTrials.gov/show/NCT00883870
Study 59: NCT Number: NCT01484574
Title: A Clinical Trial to Study the Efficacy and Safety of Different Doses of Bone Marrow Derived Mesenchymal Stem Cells in Patients With Critical Limb Ischemia Due to Buergers Disease Recruitment: Recruiting Study Results: No Results Available Conditions: Critical Limb Ischemia|Buerger's Disease Interventions: Biological: Allogeneic Mesenchymal Stem Cells|Biological: Allogeneic Mesenchymal Stem Cells|Biological: Allogeneic Mesenchymal Stem Cells|Other: Standard protocol of care Sponsor/Collaborators: Stempeutics Research Pvt Ltd Gender: Both Age Groups: Adult Phases: Phase 2 Enrollment: 126 Funded Bys: Industry Study Types: Interventional Study Designs: Allocation: Non-Randomized|Endpoint Classification: Safety/Efficacy Study|Intervention Model: Parallel Assignment|Primary Purpose: Treatment|Masking: Open Label Other IDs: SRPL/CLI/10-11/001 First Received: November 27, 2011 Start Date: January 2012 Completion Date: September 2015 Last Updated: February 10, 2012 Last Verified: February 2012 Acronym: null Results First Received: No Study Results Posted Primary Completion Date: September 2013 Outcome Measures: Relief of the rest pain|Healing of ulcerations or reduction of ulcer area in the target limb|Pain free walking distance|Major amputation free survival|Ankle brachial pressure index (ABPI) - measured by Doppler|Increase in transcutaneous partial oxygen pressure (TcPO2)|Quality of life by King's College VascuQOL questionnaire|Angiogenesis - collateral blood vessels by Magnetic resonance angiogram (MRA)|The type of adverse events AE(s), number of AE(s) and proportion of patients with AE(s).|Assessment of clinical laboratory parameters|Physical examination findings and assessment of vital signs|Assessment of electrocardiogram (ECG) parameters URL: https://ClinicalTrials.gov/show/NCT01484574
Study 60: NCT Number: NCT00616980 Title: Injection of Autologous CD34-Positive Cells for Critical Limb Ischemia Recruitment: Completed Study Results: No Results Available Conditions: Peripheral Artery Disease|Peripheral Vascular Disease|Critical Limb Ischemia Interventions: Biological: CD34-positive cells|Biological: CD34-positive cells|Biological: Saline and 5% autologous plasma Sponsor/Collaborators: Losordo, Douglas, M.D.|Baxter Healthcare Corporation Gender: Both Age Groups: Adult|Senior Phases: Phase 1|Phase 2 Enrollment: 28 Funded Bys: Other|Industry Study Types: Interventional Study Designs: Allocation: Randomized|Endpoint Classification: Safety/Efficacy Study|Intervention Model: Parallel Assignment|Primary Purpose: Treatment|Masking: Double Blind (Subject, Investigator) Other IDs: STU00009937/STU00001469|11931-02 First Received: January 24, 2008 Start Date: December 2007 Completion Date: August 2010 Last Updated: July 21, 2011 Last Verified: July 2011 Acronym: ACT34-CLI Results First Received: No Study Results Posted Primary Completion Date: April 2010 Outcome Measures: Safety of Intramuscular Injection of CD34-positive cells|Change in Rest Pain|Ulcer Healing|Functional Improvement|Limb Salvage|Disease Severity|Assessment of Co-morbidity URL: https://ClinicalTrials.gov/show/NCT00616980
Study 61: NCT Number: NCT02477540 Title: A Safety and Efficacy Study of Autologous Bone Marrow Derived Mesenchymal Stem Cells in Critical Limb Ischemia Recruitment: Not yet recruiting Study Results: No Results Available Conditions: Critical Limb Ischemia Interventions: Drug: Cellgram-CLI Sponsor/Collaborators: Pharmicell Co., Ltd. Gender: Both Age Groups: Adult|Senior Phases: Phase 1 Enrollment: 10 Funded Bys: Industry Study Types: Interventional Study Designs: Endpoint Classification: Safety/Efficacy Study|Intervention Model: Single Group Assignment|Primary Purpose: Treatment|Masking: Open Label Other IDs: Cellgram-CLI First Received: June 10, 2015 Start Date: July 2015 Completion Date: June 2017 Last Updated: June 22, 2015 Last Verified: June 2015 Acronym: null Results First Received: No Study Results Posted Primary Completion Date: June 2017 Outcome Measures: Ankle Brachial Pressure Index, ABPI|Collateral vessel formation on digital subtraction angiography (DSA)|Healing of ulcerations (change in size of ulcers) or reduction of ulcer area in the target limb|Improved transcutaneous oxygen pressure (TCPO2)|Pain on the visual analog scale (VAS)|Reduced limb amputation|Temperature change on thermography|Dose in use of a analgesic medicine|Frequency in use of a analgesic medicine|Change in rutherford classification URL: https://ClinicalTrials.gov/show/NCT02477540
Study 62: NCT Number: NCT01663376 Title: Safety and Effect of Adipose Tissue Derived Mesenchymal Stem Cells Implantation in Patients With Critical Limb Ischemia Recruitment: Completed Study Results: No Results Available Conditions: Critical Limb Ischemia Interventions: Procedure: Autologous Adipose Tissue derived MSCs Transplantation Sponsor/Collaborators: Biostar|Pusan National University Hospital Gender: Both Age Groups: Adult|Senior Phases: Phase 1|Phase 2 Enrollment: 20 Funded Bys: Industry|Other Study Types: Interventional Study Designs: Allocation: Non-Randomized|Endpoint Classification: Safety/Efficacy Study|Intervention Model: Single Group Assignment|Primary Purpose: Treatment|Masking: Open Label Other IDs: KSC-MSCs-CLI First Received: August 8, 2012 Start Date: January 2009 Completion Date: April 2011 Last Updated: March 24, 2014 Last Verified: March 2014 Acronym: null Results First Received: No Study Results Posted Primary Completion Date: March 2010 Outcome Measures: Major Adverse Events Analysis (MAEs)|Ankle-Brachial Index (ABI)|Digital subtraction angiography (DSA)|Thermography|Wong-Baker FACES Pain Rating Score|Treadmill test URL: https://ClinicalTrials.gov/show/NCT01663376
Study 63: NCT Number: NCT00304837 Title: VEGF Gene Transfer for Critical Limb Ischemia Recruitment: Completed Study Results: No Results Available Conditions: Critical Limb Ischemia|Ischemia|Leg Ulcer Interventions: Genetic: pVGI.1 (VEGF-2) Sponsor/Collaborators: Losordo, Douglas, M.D. Gender: Both Age Groups: Adult|Senior Phases: Phase 1 Enrollment: null Funded Bys: Other Study Types: Interventional Study Designs: Allocation: Randomized|Intervention Model: Crossover Assignment|Masking: Double-Blind Other IDs: BB-IND 11948 First Received: March 16, 2006 Start Date: null Completion Date: April 2008 Last Updated: October 18, 2010 Last Verified: April 2008 Acronym: null Results First Received: No Study Results Posted Primary Completion Date: null Outcome Measures: URL: https://ClinicalTrials.gov/show/NCT00304837
Study 64: NCT Number: NCT01558908 Title: Phase I/II Trial of Endometrial Regenerative Cells (ERC) in Patients With Critical Limb Ischemia Recruitment: Not yet recruiting Study Results: No Results Available Conditions: Peripheral Vascular Diseases Interventions: Biological: Administration of ERC Sponsor/Collaborators: Medistem Inc. Gender: Both Age Groups: Adult|Senior Phases: Phase 1|Phase 2 Enrollment: 15 Funded Bys: Industry Study Types: Interventional Study Designs: Endpoint Classification: Safety/Efficacy Study|Intervention Model: Single Group Assignment|Primary Purpose: Treatment|Masking: Open Label Other IDs: MEDS-027 First Received: March 18, 2012 Start Date: May 2012 Completion Date: July 2013 Last Updated: March 18, 2012 Last Verified: March 2012 Acronym: null Results First Received: No Study Results Posted Primary Completion Date: May 2013 Outcome Measures: Safety|Efficacy URL: https://ClinicalTrials.gov/show/NCT01558908
Study 65: NCT Number: NCT02501018 Title: Study to Assess the Efficacy and Safety of CLBS12 in Patients With Critical Limb Ischemia (CLI) Recruitment: Not yet recruiting Study Results: No Results Available Conditions: Critical Limb Ischemia (CLI) Interventions: Biological: CLBS12|Drug: SOC Sponsor/Collaborators: Caladrius Biosciences, Inc. Gender: Both Age Groups: Adult|Senior Phases: Phase 2 Enrollment: 35 Funded Bys: Industry Study Types: Interventional Study Designs: Allocation: Randomized|Endpoint Classification: Safety/Efficacy Study|Intervention Model: Parallel Assignment|Primary Purpose: Treatment|Masking: Open Label Other IDs: CLBS12-01 First Received: July 14, 2015 Start Date: January 2016 Completion Date: July 2020 Last Updated: July 23, 2015 Last Verified: July 2015 Acronym: null Results First Received: No Study Results Posted Primary Completion Date: January 2020 Outcome Measures: Time to continuous CLI-free status URL: https://ClinicalTrials.gov/show/NCT02501018
Study 66: NCT Number: NCT01903044 Title: Safety and Efficacy of Autologous Bone Marrow Stem Cells for Lower Extremity Ischemia Treating Recruitment: Not yet recruiting Study Results: No Results Available Conditions: Lower Extremity Ischemia|Leg Ulcer|Peripheral Vascular Disease|Diabetic Foot|Gangrene Interventions: Procedure: BM-MNC injection Sponsor/Collaborators: Pontif__cia Universidade Cat_¸lica do Paran_˙|Instituto de Mol_©stias Cardiovasculares de S_üo Jos_© do Rio Preto, Brazil|Hospital Sao Rafael|Hospital Geral Nacional Enrique Cabrera, Cuba|Instituto de Hematolog__a e Inmunolog__a, Cuba|Funda_¤_üo Arauc_˙ria, Brazil Gender: Both Age Groups: Adult|Senior Phases: Phase 1|Phase 2 Enrollment: 60 Funded Bys: Other Study Types: Interventional Study Designs: Endpoint Classification: Safety/Efficacy Study|Intervention Model: Single Group Assignment|Primary Purpose: Treatment|Masking: Open Label Other IDs: ICMI_ 404732/2012-7 First Received: July 10, 2013 Start Date: September 2013 Completion Date: September 2015 Last Updated: June 26, 2014 Last Verified: July 2013 Acronym: null Results First Received: No Study Results Posted Primary Completion Date: September 2014 Outcome Measures: Wound healing (wound size, wound stage) - monitoring the healing of trophic lesions|Clinical outcome classification|Pain and analgesics use|Quality of life outcome|Improvement of the coronary and collateral circulation.|Survival without amputation URL: https://ClinicalTrials.gov/show/NCT01903044