FDA Cracks Down on Stem Cell Clinics But Patients Are Still at Risk

FDA Cracks Down on Stem Cell Clinics But Patients Are Still at Risk

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August 29, 2017

TIME Health

For more, visit TIME Health.


Comments by Dr. Mike are in Bold

On Monday, the U.S. Food and Drug Administration (FDA) announced that the agency is targeting clinics that offer unproven stem cell therapies, calling such offices “unscrupulous clinics” selling “so-called cures.” The FDA seized materials from one clinic in California, and sent a warning letter to another in Florida.

“The FDA will not allow deceitful actors to take advantage of vulnerable patients by purporting to have treatments or cures for serious diseases without any proof that they actually work,” said FDA Commissioner Dr. Scott Gottlieb in a statement.

Recently, many stem cell clinics have opened doors for business all over the U.S. As in most business, many of these clinics cut corners to try and make a quick buck. These clinics use product that does not comply with section 361 of the FDA regulations, and/or the manufacturer is unable to verify (through third party test results) the number of live mesynchymal stem cells in their product, and/or the practitioner often lack expertise in these newer procedures. On the other hand, it’s quite interesting to observe the FDA to be concerned about the safety of the public. Even though public safety should be the FDA’s primary focus, this is rather unusual since the FDA constantly allows very harmful drugs, vaccines and treatments on the market. Do the Big Pharma feel threatened to know that stem cells are the future of medicine?

The agency announced that on Friday, Aug. 25th, U.S. Marshals seized five vials of a vaccine that is intended for people at a high risk for smallpox (for example, people in the military) from StemImmune Inc. in San Diego, California. The FDA says it learned that StemImmune was using the vaccines as well as stem cells from body fat to create an unapproved stem cell therapy. On its website, StemImmune says “The patient’s own (autologous, adult) stem cells, armed with potent anti-cancer payloads, function like a “Trojan Horse,” homing to tumors and cancer cells, undetected by the immune system.” The stem cell treatment was injected into the tumors of cancer patients at the California Stem Cell Treatment Centers in Rancho Mirage and Beverly Hills, California.

Stem cell clinics like this one make huge mistakes when they make claims like these. The FDA has monopolized the word ‘cure’ for the drugs produced by the big pharma, and therefore making these claims or promoting a cancer treatment with a stem cell-based therapy is asking for trouble. We already know for a fact that adult derived stem cells (from the patient’s fat or bone marrow) is significantly less effective than the use of stem cells derived from umbilical cord tissue (in particular the Wharton’s Jelly). Please refer to our document “5 key questions you should ask when considering stem cell therapy” which highlights the many advantages using ‘young’ stem cells.

In addition, published research shows that umbilical cord derived mesynchymal stem cells:

1)    do not undergo Malignant Transformation during Long-Term Culturing in Serum-Free Medium (http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0098565)

  • do not pose a risk for metastasis of tumor cells (Kalaszczynska, et. al, Wharton’s Jelly Derived Mesenchymal Stem Cells: Future of Regenerative Medicine? Recent Findings and Clinical Significance. Biomed Res Int. 2015; 2015: 430847)
  • promote proteins that halt the cell cycle of cancer cells and promote tumor suppressing genes (Watson, N. et.al. Discarded Wharton’s Jelly of the Human Umbilical Cord: A Viable Source for Mesenchymal StemCells. Cytotherapy. 2015 January; 17(1): 18-24.)

Even though this is what recent research shows, cancer is currently not an indication to be treated with stem cells listed by the FDA.

ORE: Three People Are Nearly Blind After Getting a Stem Cell Treatment

The FDA also sent a warning later to U.S. Stem Cell Clinic in Sunrise, Florida. The company recently came under public scrutiny when a March report revealed that three people had severe damage to their vision — one woman went blind—after they were given shots of what the company said were stem cells into their eyes during a study sponsored by the clinic. The FDA says that an inspection of U.S. Stem Cell Clinic revealed that the clinic was using stem cells to treat diseases like Parkinson’s, amyotrophic lateral sclerosis (ALS), chronic obstructive pulmonary disease (COPD), heart disease and pulmonary fibrosis. According to the FDA, there are currently only a limited number of stem cell therapies approved by the agency—including ones involving bone marrow, for bone marrow transplants in cancer care, and cord blood for specific blood-related disorders. There are no approved stem cell treatments for other diseases.

The FDA says U.S. Stem Cell Clinic also attempted to interfere with the FDA’s most recent inspection by refusing to allow FDA investigators to enter without an appointment, and denied the agency access to its employees. “Refusing to permit entry or FDA inspection is a violation of federal law,” the FDA says.

Action by the FDA on clinics promoting unproven stem cell therapies is “a long time coming,” says Sean Morrison, former president of the International Society for Stem Cell Research (ISSCR) and director of the Children’s Research Institute at UT Southwestern. “Clinics are preying on the hopes of desperate patients claiming they can cure all manner of diseases with stem cells that have not been tested in clinical trials, and in some cases, are flat out impossible.”

In the past, medical experts were concerned over Americans traveling to countries with less medical regulation for stem cell therapies, but Morrison says such clinics have been popping up stateside over the last five years. “It’s not a few companies in the U.S. making claims about therapies with stem cells,” says Morrison. “It’s scores of companies. The problem has exploded in the U.S.”

Morrison blames the lack of FDA crackdown in the past for the growing problem. “At some point people made the calculation that the FDA didn’t seem to be enforcing these laws,” he says. “The margins are huge. They charge people tens of thousands of dollars.”

Since stem cell therapy is still an active and legitimate area of scientific research, it can be hard for Americans to figure out what is safe and effective and what is not. Even when it comes to clinical trials, the scientific soundness is murky. A July 2017 paper reported that 18 U.S. companies have registered “patient-sponsored” stem cell studies on ClinicalTrials.gov. That means that the patients receiving the treatment paid for them, which isn’t the case in more legitimate studies. None of these were gold standard studies: meaning the people were not randomly assigned to receive the treatment or not, so the participants knew they were receiving the therapy — that could bias the results. Only seven of the studies disclosed upfront that patients had to pay to join the study, and none revealed that the costs ranged from $5,000 to $15,000 a treatment, Wired reports.

While Morrison says he’s glad the FDA has taken action, he says it’s not enough—at least not yet. “The FDA has to show that there is really a sustained commitment to enforcement,” he says. “When the FDA wasn’t bringing actions against these companies, I think people thought this meant that it was a gray area and that they could get away with it.”

Undoing that damage could be a long process, and one that Morrison says needs consistent attention by the agency. In a letter released on Monday, FDA commissioner Gottlieb said the agency is stepping up enforcement of stem cell therapies and regenerative medicine. “I’ve directed the FDA to launch a new working group to pursue unscrupulous clinics through whatever legally enforceable means are necessary to protect the public health,” said Gottlieb. Whether those efforts have an impact remains to be seen.

Neo Matrix Medical and the FDA:


WHERE does umbilical cord tissue come from?

All birth tissue products are obtained from C-section deliveries from normal, full-term pregnancies in U.S. Donors that consent to use of their birth tissues are carefully screened prior to the use of their tissues in manufacturing our products.

Comprehensive medical and social histories of the donors are obtained and tissues are procured, processed, and tested in accordance with standards established by the AATB (American Association of Tissue Banks) and FDA requirements to minimize potential risks of disease transmission to recipients. Infectious disease testing is performed at a certified laboratory in accordance with the Clinical Laboratory Improvement Amendments of 1988 (CLIA) and 42 CFR part 493.

Each donor is tested for HBsAg (Hepatitis B Surface Antigen), HBcAb (hepatitis B core Antibody), HCV (hepatitis C Antibody), HIV I/II-Ab (Antibody to Human Immunodeficiency Virus Types 1 and Syphilis detection test, HIV NAT (HIV Nucleic Acid Test), and HCV NAT (HCV Nucleic Acid Test).

All products are tested post-sterilization to demonstrate the absence of bacterial and fungal pathogens and are non-pyrogenic. All testing results are reviewed by the Medical Director of Predictive Biotech (2749 E. Parleys Way, Suite 101, Salt Lake City, UT 84109) prior to release of product.

The FDA identified “Umbilical Cord Tissue” as a “structural tissue” and states that structural tissue, in addition to cytokines and other factors, can and may have live cells present. The products we use align directly with the FDA “Homologous Use” definition for structural tissues. The product we use is fully compliant with all Section 361 regulations of the FDA.

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