Apr 29, 2024
We are pleased to announce that San Diego Orthobiologics Medical Group physicians, Dr. Christopher Rogers and Dr. Mary Ambach were first in the US to publish on the safety and efficacy of a GMP-manufactured stem cell product for patients with osteoarthritis. 1 This FDA / IRB approved study was sponsored by Personalized Stem Cells (PSC), a leader in stem cell research for orthopedic conditions. 2
Patients with moderate to severe knee osteoarthritis who had not responded to standard medical care were treated with PSC-01, an autologous, adipose-derived cell product, also known as stromal vascular fraction.
Stromal vascular fraction (SVF) is obtained from a patient’s own adipose tissue (fat) using a simple in-office procedure. Prior clinical trials outside the United States have shown that SVF therapy is safe and effective for knee osteoarthritis. In several clinical trials, adipose-derived cells have demonstrated a superior ability to reduce pain, improve function and promote cartilage regeneration than bone-marrow derived cells. 3, 4, 5
In this clinical trial, the treatment was shown to be safe, well-tolerated and effective. Most of the subjects had been advised to consider joint replacement surgery, however at one year follow-up, 79% were satisfied and able to avoid surgery altogether. In addition, a single treatment was shown to decrease pain, increase function and improve quality of life for up to 2.5 years.
Treatments that use a patient’s own cells represent an exciting advancement in the field of orthopedic regenerative medicine. SDOMG and PSC are committed to the responsible development of medical products that use a patient’s own cells to safely decrease pain and improve function. While SVF products require FDA approval, this treatment offers real hope to all patients who suffer with joint pain.
To learn more about your current treatment options for orthopedic conditions, please schedule a consultation with one of our physicians today:
San Diego Orthobiologics Medical Group
6125 Pasel Del Norte, Suite 100
Carlsbad, CA 92011
(760) 909-2355
https://sdomg.com
[email protected]
REFERENCES
- https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11036882/pdf/scd.2024.0008.pdf
- https://personalizedstemcells.com
- https://www.thekneejournal.com/article/S0968-0160(21)00192-7/abstract
- https://journals.sagepub.com/doi/abs/10.1177/03635465211014500
- https://journals.sagepub.com/doi/abs/10.1177/03635465211053893
Jun 23, 2023
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.
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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]
