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]
Jun 16, 2023
Join us on our free Facebook Live Series called “Ask the Docs”. In this session, you can ask SDOMG Physicians everything you want to know about rotator cuff tendon tears and the cellular treatments available to help.
Date and Time: June 20, 2023, 12:00 PT
Subject: Rotator Cuff Tendon Tears
Hosts: Drs. Chris Rogers and Edmund Evangelista
Video coming soon!
Apr 18, 2023
Dr. Mary A. Ambach was invited to give a lecture by the American Academy of Orthopedic Medicine. She talked about How to Navigate the Use Of Orthobiologics for Low Back Pain. She presented on the use of Platelet Rich Plasma (PRP) and Bone marrow concentrate (BMAC) to treat Lumbar spine conditions. She also talked about the current scientific evidence on the use of stem cells to treat degenerative disc disease, facet joint arthritis, nerve pain, and other spinal conditions.
Apr 7, 2023
Our latest FREE Webinar on Hip Pain: Causes and Non-Surgical Treatment Options was held April 11, 2023.
Non-surgical therapies were discussed to treat the most common causes of hip pain like Platelet Rich Plasma (PRP) and other cell-based therapies. Questions were answered from physician experts in Regenerative Medicine.
Feb 1, 2023
Do you want to know how customized exercises can improve your outcome after PRP and Stem cell therapy injections? Learn the difference between Traditional Physical therapy and “Regenerative” Physical therapy.
Date and Time : Feb 7, 2023 . 12 pm PT
Speaker(s): Darren Mallinson, PT
Darren is a European-trained physical therapist with a wide breadth of experience. He received his training from the Hoogeschol van Amsterdam and has maintained a lifelong passion to help people return to their lives. Darren uses his physical therapy training supplemented with a Strength and Conditioning Certification to treat the whole patient. From working with soccer players in Holland, dancers in New York, surfers in San Diego, and injured workers in Seattle, he has been able to help many people return to the activities that they love. He has been working closely with our Regenerative Medicine physicians at San Diego Orthobiologics Medical Group as a part of a multidisciplinary team to improve patient outcomes.
Darren will be joined by the Regenerative medicine physician experts at the San Diego Orthobiologics Medical Group for the Question and Answer portion after the presentation.
Dr. Chris Rogers
Dr. Mary A. Ambach
Dr. Mirielle Diaz
Dr. Edmund Evangelista
Jan 1, 2023
Vanessa Vander Heide joins San Diego Orthobiologics Medical Group providing massage therapy skills with the therapeutic application of BioWave Therapy.
Vanessa graduated Summa cum Laude with Department Distinction from San Diego State University with a Bachelor’s degree in Kinesiology with an emphasis in health, fitness, and nutrition. She was an accomplished student-athlete and competitive gymnast for 10 years. Her passion for gymnastics led to a 20-year-long career in the gymnastics industry before transitioning her career to become a Holistic Health Practitioner and Massage Therapist.
As a perpetual student, her career transition was spurred on after becoming a certified level 1 Neurokinetic Therapist which led to her becoming a Certified Massage Therapist and Holistic Health Practitioner in 2017. Her thirst for knowledge and love of the intertwined workings of the mind, body, and spirit motivated her to become a certified, first-degree Reiki Practitioner.
Vanessa specializes in therapeutic, relaxation, and deep-tissue massage. She incorporates various massage techniques to achieve the desired outcome to meet each client’s needs. For the past five years, she worked as a mobile massage therapist bringing her gift of massage into the client’s home.
To learn more about Vanessa or schedule an appointment, fill out the form below:
