The U.S. Food and Drug Administration announced it had issued a warning to StemGenex Biologic Laboratories LLC, its owner/manager Rita F. Alexander and medical director Jenny R. Galloway, M.D. for marketing a stem cell product without federal approval and for deviating from good manufacturing practices (cGMP). The agency says that patients could be at risk from microbial contamination.
According to an FDA press release,
“The potential health benefits of regenerative medicine have spurred major progress in stem-cell biology over the past several decades. But we continue to see bad actors exploit the scientific promise of this field to mislead vulnerable patients into believing they’re being given safe, effective treatments; when instead these stem cell producers are leveraging the field’s hype to push unapproved, unproven, illegal, and potentially unsafe products. This is putting patients’ health at risk. It’s also putting at risk the long-term viability of the industry and of effective products, when other operators are misleading consumers by marketing unproven therapies using claims of safety and benefit,” said FDA Commissioner Scott Gottlieb, M.D. “We support sound, scientific research and regulation of cell-based regenerative medicine. The FDA has advanced a comprehensive policy framework to promote the efficient approval of regenerative medicine products. At the same time, we’ll continue to take enforcement actions against companies that abuse the trust of patients and endanger their health with uncontrolled manufacturing conditions or by promoting so-called ‘treatments’ that haven’t been proven safe or effective for any use.”
StemGenex SVP – Illegal Marketing and Substandard Lab – a Deadly Combination
The agency says the company was illegally marketing their stem cell products for a variety of serious conditions including Alzheimer’s disease, Crohn’s disease, Type I and Type II diabetes, fibromyalgia, spinal cord injury, chronic obstructive pulmonary disease, multiple sclerosis, muscular dystrophy, Parkinson’s disease, peripheral neuropathy and rheumatoid arthritis.
The SVF product made by StemGenex is formulated to be used intravenously, by inhalation, and directly into the spinal canal.
StemGenex SVP is considered both a drug and a biologic product requiring FDA approvals. The agency says the company had no such approval.
Not only doesn’t SVP have proper approvals, regulators found poor conditions during an inspection of StemGenex’s manufacturing facility earlier this year in San Diego. FDA investigators found “evidence of significant deviations” from current good manufacturing practice requirements in the manufacture of the SVF product; including unvalidated manufacturing processes, an uncontrolled environment, lack of control over the components used in production, and the lack of sufficient and validated product testing.
Officials believe these cGMP violations demonstrate a lack of sufficient and validated product testing (sterility and endotoxin testing) and pose a significant risk that the “SVF product may be contaminated with microorganisms or have other serious product quality defects.”
The agency also found insufficient testing protocols to monitor purity, sterility and dosage. In one instance, the FDA found that one of the SVP components was marked for research only and was not sterile.
More ominously, investigators claim the company knew of adverse reactions and events yet failed to investigate those complaints.
Stem Cell Therapy – Godsend or Nightmare?
Recently there have been a rash of suspect stem cell products hitting the market and causing injuries to patients. (Please see our important patient rights guide for users of the recalled ReGen stem cell product.)
FDA Commissioner Scott Gottlieb is correct in warning about the bad actors in the stem cell arena. The many fly by night operators and mounting injury claims are certainly hurting the industry at a critical time in its development.
While stem cells certainly have promise, many manufacturers are making wild miracle cure claims and praying on patients’ desperation for a cure. Instead of getting appropriate treatment, some folks are spending tens of thousands of dollars of their savings to get unproven products from unsafe laboratories.
We worry that many patients seeking cures and remedies are vulnerable to deceptive sales tactics and may receive treatments that at best are useless and at worst, dangerous.
The government is stepping up its enforcement to protect people from unproven claims of miracle cures, dishonest stem cell clinics and unsterile labs and manufacturing facilities.
What can you do to stay safe? Make sure that any stem cell treatment you are considering is either:
- FDA-approved, or;
- Being studied under an Investigational New Drug Application (IND), which is a clinical investigation plan submitted and allowed to proceed by the FDA.
Also consider who is going to administer the product. We have seen a number of chiropractors and even acupuncturists administering these products. In many states that is illegal. In our opinion, whether legal or not, it is unwise. Seek a medical doctor for stem cell therapy.
Also, be aware that many products that claim they are live stem cells are not. The science is still a long way from being settled but there are concerns with the efficacy of dead stem cells and sterility of live ones. Once again, rely on an experienced MD or DO and not a clinician or non-medical doctor.
How Safe is Stem Cell Therapy?
Leaving aside some of the wild miracle cure claims that are yet unproven, stem cell products can be safe if processed in a sterile facility with proper procedures and if properly tested. Already, however, we have been contacted by patients who have suffered a wide variety of adverse reactions including losing the ability to walk.
The FDA reports a patient who 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.
The FDA says other potential safety concerns for unproven stem cell 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
- “The growth of tumors.”
An indirect risk of stem cell therapy is graft versus host disease (GvHD). That occurs when the transplanted stem cells view your body as foreign and begin attacking everything. It is an immune response that means the stem cells are working, except they are attacking both healthy and diseased cells.
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.
I Used StemGenex SVP and Experienced a Complication? Who Is Responsible?
Under U.S. products liability law, the maker of defective biologic products such as stem cell products that are responsible for any adverse reactions or complications. The distributor of the product and the medical personnel administering the product may also be responsible.
Even though stem cells are produced by the human body, they are still regulated by the FDA. The government wants to insure they are processed safely and that there is a basis for the claims made by the company offering them.
StemGenex advertises that it has its own clinic and doctors. According to their website, the StemGenex Stem Cell Research Centre’s doctors and clinicians bring “vast experience to our patients, our doctors utilize advanced protocols to ensure patients receive unparalleled service and safe and efficacious stem cell treatments. Our physicians and clinicians are dedicated to putting patients first, enhancing their quality of life and making their health, well-being and comfort a priority throughout the stem cell treatment process.”
Who is right? The FDA or StemGenex? On this one, our bet is with the FDA.
Whether or not you received StemGenex products at their research center, a doctor’s office or a hospital, the folks overseeing the administration of the stem cells may also be liable for any injuries you may sustain, particularly when they use a non-FDA approved product for conditions not authorized by the FDA.
Did You Take StemGenex SVP Series Stem Cell Products and Suffer a Complication?
We are seeking people who have taken SVP stem cell products made by StemGenex and that have suffered complications or adverse medical events. At this point, we remain in the early investigation stages as we acquire more information.
In the U.S. you have important legal rights and may be entitled to compensation for medical expenses, pain and suffering, future medical needs, lost wages and other damages due to contaminated or unsafe stem cell products. For more information, visit our dangerous drug and defective medical products page. Ready to see if you have a case? Contact us online, by email at [hidden email] or by phone at 800.669.7782. Cases accepted nationwide and are handled on a contingent fee basis meaning no fee unless we recover money on your behalf. In medical products cases, we frequently partner with other national law firms to prosecute these cases.
Update: Please see our new cornerstone content on the safety of stem cell products and how you can receive compensation if injured by dangerous stem cell therapies or products used for non FDA approved uses.