FDA warnings about stem cell therapies

Courtesy of the U.S. Food and Drug Administration

Stem cell therapies may offer the potential to treat diseases or conditions for which few treatments exist.

Sometimes called the body’s “master cells,” stem cells are the cells that develop into blood, brain, bones and all of the body’s organs. They have the potential to repair, restore, replace and regenerate cells, and could possibly be used to treat many medical conditions and diseases.

Today, doctors routinely use stem cells that come from bone marrow or blood in transplant procedures to treat patients with cancer and disorders of the blood and immune system.

But the U.S. Food and Drug Administration is concerned that some patients seeking cures and remedies are vulnerable to stem cell treatments that are illegal and potentially harmful.

Lack of sleep

From page 4 increases, affordable. Eggs are also a great source of vitamin B12, which helps our cells metabolize energy and function at our best.

Calcium-rich foods: Foods like dairy, soybeans, sardines and leafy greens are worthwhile additions to your plate when you need energy. They’re high in protein to keep you feeling fueled, and also are packed with calcium.

A lack of calcium can make it challenging to get quality sleep, possibly because of calcium’s link to healthy blood pressure.

Iron-rich foods: Not getting enough iron can lead to general fatigue and even anemia. Iron is the main nutrient that delivers oxygen throughout our bodies.

To help you feel energized on a regular

FDA regulates only U.S. use

The FDA has the authority to regulate stem cell products in the United States.

The only stem cell-based products that are FDA-approved for use in the United States consist of blood-forming stem cells (hematopoietic progenitor cells) derived from cord blood.

These products are approved for limited use in patients with disorders that affect the body system that is involved in the production of blood (called the hematopoietic system).

These FDA-approved stem cell products are listed on the FDA website. Bone marrow also is used for these treatments but is generally not regulated by the FDA for this use.

With limited exceptions, new products being investigated must go through a thorough FDA review process as investigators prepare to determine the safety and effec- basis, make sure to include iron-rich foods like spinach, kale, red meat and clams in your eating pattern. Clams in particular are also rich in energy-boosting nutrients like vitamin B12 and coenzyme Q10.

Bottom line

Sleep is important for short- and longterm health and wellness. Try adjusting your routine to help you get at least seven hours a night.

For days when you didn’t catch enough zs, these foods can give you a boost and set you up for better sleep in the nights to come.

EatingWell is a magazine and website devoted to healthy eating as a way of life. Online at eatingwell.com.

© 2022 Meredith Corporation. Distributed by Tribune Content Agency, LLC.

tiveness of products in well-controlled human studies, called clinical trials. The FDA has reviewed many stem cell products for use in these studies. (You can learn more about clinical trials on the FDA’s website.)

That said, some clinics may inappropriately advertise stem cell clinical trials without submitting to the FDA’s review process. Some clinics also may falsely advertise that FDA review and approval of the stem cell therapy is unnecessary.

Safety concerns

All medical treatments have benefits and risks. But unproven stem cell therapies can be particularly unsafe.

For instance, attendees at a 2016 FDA public workshop discussed several cases of severe adverse events. One patient became blind due to an injection of stem cells into the eye. Another patient received a spinal cord injection that caused the growth of a spinal tumor.

Other potential safety concerns for unproven treatments include:

• Administration site reactions,

• The ability of cells to move from placement sites and change into inappropriate cell types or multiply,

• Failure of cells to work as expected, and

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Your wish is its command

Researchers have demonstrated that individuals who cannot voluntarily move the upper and lower parts of their body can, after extensive training, operate wheelchairs with their minds, even in a natural, cluttered environment.

In the small study, three persons who were unable to use their arms and legs due to spinal injuries were able to move their wheelchair using only their thoughts, which were translated into mechanical commands.

“We show that mutual learning of both the user and the brain-machine interface algorithm are both important for users to successfully operate such wheelchairs,” said José del R. Millán, a researcher at the University of Texas at Austin.

Each of the participants underwent training sessions three times per week for two to five months. The participants wore a skullcap that detected their brain activities through electroencephalography (EEG), which would be converted to mechanical commands for the wheelchairs via a brainmachine interface (BMI) device.

The participants were asked to control the direction of the wheelchair by thinking about moving their body parts. Specifically, they needed to think about moving both hands to turn left and both feet to turn right.

“We see from the EEG results that the subject has consolidated a skill of modulating different parts of their brains to gener- ate a pattern for ‘go left’ and a different pattern for ‘go right,’” Millán said.

By the end of the training, all participants were able to move their wheelchairs across a cluttered hospital room, to varying degrees of success. They were asked to navigate around obstacles, such as a room divider and hospital beds, which were set up to simulate the real-world environment.

John Schieszer

Diet may help lower hip fracture risk

Increasing intake of protein and drinking regular cups of tea or coffee may be a good way for women to reduce their risk of suffering a hip fracture, according to new research.

Food scientists have found that for women, a 25 gram a day increase in protein was associated with, on average, a 14% re-

Stem cells

From page 5

• The growth of tumors.

Note: Even if stem cells are your own cells, there are still safety risks such as those noted above. In addition, if cells are manipulated after removal, there is a risk of contamination of the cells.

Before trying stem cell therapies

duction in their risk of hip fracture. In a surprise twist, they also discovered that every additional cup of tea or coffee they drank was linked with a 4% reduction in risk.

Writing in the journal Clinical Nutrition, the researchers noted that the protective benefits were greater for women who were underweight, with a 25 gram/day increase in protein reducing their risk by 45%.

The protein could come in any form: meat, dairy or eggs, and for people on a plant-based diet, from beans, nuts or legumes. Four eggs would provide around 25 grams of protein as would a 4-ounce steak or piece of salmon.

The observational study reviewed records from more than 26,000 middleaged women for whom they were able to identify associations between factors in diet and hip fractures, which were identified through hospital records.

Women who are underweight may be tion before getting treatment — even if the stem cells are your own.

• Request the facts and ask questions if you don’t understand. Make sure you understand the entire process and known risks before you sign.

If you’re considering treatment in another country:

• Learn about regulations that cover products in that country.

• Do you have pain, pricking or shooting sensations in your hands and feet?

• Lack of coordination and or falling?

• Poor quality and overall lack of sleep?

Dr. Carle has been in practice in Greater Baltimore since 1990 and has over 30 years of experience in helping patients relieve pain and/or reduce the suffering of chronic pain.

You may be told that because these are your cells, the FDA does not need to review or approve the treatment. That is not true [in the United States].

If you’re considering treatment in the United States:

• Ask if the FDA has reviewed the treatment. Ask your healthcare provider to confirm this information. Ask for this informa-

Now

For

• Know that the FDA does not have oversight of treatments done in other countries. The FDA typically has little information about foreign establishments or their stem cell products.

• Be cautious. If you’re considering a stem cell-based product in a country that may not require regulatory review of clinical studies, it may be hard to know if the experimental treatment is reasonably safe.