We want to make you aware of a public health risk that has emerged in San Diego – the illegal sale of fetal tissues for orthopedic conditions. As a result, the FDA and Federal Trade Commission have issued these warnings:
Wharton’s jelly is a tissue within the umbilical cord – the tube connecting a developing fetus with its mother’s placenta. It contains blood and cells that are claimed to useful for orthopedic conditions. But, because it comes from a donor’s body there are multiple safety concerns. Several medical clinics in San Diego now sell Wharton’s jelly injections to their patients, making unsubstantiated claims about its safety and efficacy. We would like to share several issues with this illegal practice with you.
Is Wharton’s Jelly Safe?
The safety of Wharton’s jelly in patients is unknown as no research studies on its use have been conducted in humans.
Is It Effective for Arthritis?
Again, this is unknown. There are no research studies on the efficacy of Wharton’s jelly for any orthopedic condition. Claims made to the contrary are simply unsubstantiated.
Is Wharton’s Jelly FDA-Approved?
The US Food and Drug Administration has issued guidance to physicians regarding the use of Wharton’s jelly. They maintain that Wharton’s jelly is a drug and requires FDA approval. But Wharton’s jelly is not FDA-approved because there are no studies on it’s safety or efficacy and physicians are not permitted to inject it into their patients.
Is my Doctor Permitted to Sell a Drug that is Not FDA-Approved?
Selling a drug that is not FDA-approved constitutes the sale of an illegal drug and may put patients at risk. The FDA has filed injunctions against medical practices that sell illegal drugs and the Federal Trade Commission has fined doctors who make unsubstantiated claims of safety or efficacy.
Is there Any Scientific Evidence for the Use of a Patient’s Own Cells in the Treatment or Orthopedic Conditions?
There are several FDA-compliant, cell-based therapies available to patients with orthopedic conditions. These treatments use a patient’s own cells and include: platelet-rich plasma (PRP), micro-fragmented adipose tissue (MFAT), and bone marrow aspirate (BMAC). These non-surgical treatments have substantial scientific evidence to support their safety and efficacy for several types of orthopedic conditions.
The physicians at SDOMG are board certified, fellowship-trained and nationally recognized experts in using a patient’s own cells to treat orthopedic conditions. We only offer FDA-compliant therapies with substantial scientific evidence for safety and efficacy. If you have any questions about our innovative therapies, please call us for a consultation today. Please use the form to get in touch with our team, or use the contact information listed below.
Thank you and stay safe,
San Diego Orthobiologics Medical Group
6125 Paseo Del Norte, Suite 100
Carlsbad, CA 92011
(760) 909-2355 [email protected]
Dr. Christopher Rogers was honored to speak at the April 2021 La Jolla Golden Triangle Rotary Club meeting. Topics of the lecture included a history of stem cell therapy in San Diego and an update on FDA-approved clinical trials for knee osteoarthritis. To see a copy of the lecture, visit the San Diego Orthobiologics Medical Group YouTube channel or view the video linked below!
STEM CELL RESEARCHERS AND THE FDA WARN PATIENTS ABOUT FRAUDULENT CLINICS THAT SELL ILLEGAL BIRTH TISSUE PRODUCTS
Stem cell therapies have the potential to treat many medical conditions that were previously untreatable. But, despite their enormous promise, stem cell therapies are only in the early stages of clinical development. For the past two decades, hundreds of scientific studies have been conducted, but much more work is required to prove the safety and efficacy of these treatments.
Recently, the FDA posted awarning to patients about the rising number of illegal stem cell clinics. In addition, a newly releasedshort film documents the fraudulent and illegal activity of these stem cell clinics. Experts in the field were interviewed and shared their experience, warning patients about the fraud and abuse that is rampant in the United States.
Unscrupulous healthcare providers sell illegal birth tissue products and fraudulently promote them as “stem cell therapy”. These products include amniotic fluid, umbilical cord blood and exosomes. They are not FDA approved because they have not been tested for safety or efficacy. Physicians are not permitted to use them. In fact, patients have been harmed by them. And not surprisingly, none of these products have been shown to contain actual live stem cells.
Patient Education is Key
The physicians at San Diego Orthobiologics Medical Group support the experts and would like to educate patients about the risks of using illegal stem cell products. We only use FDA compliant cell therapies for our patients. We do not use birth tissue products because they have not been tested for safety or efficacy and are not permitted by the FDA. Our physicians are recognized leaders in the field of Orthobiologics, conductFDA approved stem cell research and have published in the peer-reviewed scientific literature.
Dr. Christopher Rogers, founder of San Diego Orthobiologics Medical Group (SDOMG) and medical director for Personalized Stem Cells, Inc. (PSC), is pleased to announce that they have obtained FDA approval to treat patients with severe COVID-19 using stem cells.
In record time, Personalized Stem Cells, Inc. has received approval from the U.S. Food and Drug Administration to conduct a clinical trial of stem cells for the treatment of patients with severe COVID-19 (1). Stem cell therapy has already shown encouraging results in studies conducted in Spain, Israel, and China. Dr. Rogers and his coauthors recently published a landmark peer-reviewed scientific article on the rationale behind the use of stem cells to treat COVID-19 (2). Support from entire team at SDOMG and PSC was critical to achieving this exciting accomplishment. We are eager to initiate this clinical trial and demonstrate the safety and efficacy of this innovative and promising therapy.
FDA has sent warning letters to companies that process, distribute and offer umbilical cord blood derived products and unapproved stem cell products to patients. FDA also issued a safety alert about exosome products which are not FDA approved and had multiple recent reports of serious adverse events associated with its use.