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:
- FTC Hold Companies Accountable for Deceptive Claims Regarding Stem Cell Therapy
- United States of America Department of Health and Human Services: FDA’s Regulatory Oversight of Regenerative Medicine Products
What is Wharton’s Jelly?
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