R3 Stem Cell Issues Statement Regarding FDA Warning Letter

R3 Stem Cell Issues Statement Regarding FDA Letter, clarifying no product recalls ever performed, no reported patient harm, and treatment disclosures present.

SCOTTSDALE, AZ, UNITED STATES, November 5, 2026 /EINPresswire.com/ — R3 Stem Cell, one of the world’s largest provider of regenerative therapies, today issued the following statement regarding the R3 Stem Cell FDA warning letter it received from the U.S. Food and Drug Administration (FDA) dated August 2026.

R3 Stem Cell takes its regulatory obligations seriously and respects the FDA’s role in protecting patients. The company has responded to the agency and is committed to continued constructive dialogue to address the points raised in the letter. Importantly, the warning letter does not involve any product recall, and R3 Stem Cell is not aware of any reports of patient harm associated with the matters raised in the letter. As a clarification, R3 Stem Cell is not a manufacturer and does not produce any biologics. R3 recently commenced its Institutional Review Board (IRB) Approved Global Observational Safety Database for umbilical cord derived therapies.

The regenerative therapies described in R3 Stem Cell’s educational and consumer materials include disclosures referring to procedures performed at partner Centers of Excellence outside the United States, in accordance with the laws and regulations of the countries where they take place. R3’s materials include disclosures to that effect, and the company is reviewing its communications to make this distinction clear. Any USA regenerative medicine therapy decisions and recommendations are made under the patient-physician relationship with transparent consent form protocols.

Just this year, R3 Stem Cell’s USA Centers have performed stem cell procedures safely on actor Dennis Quaid, NBA Champion and ESPN Analyst Kendrick Perkins, Super Bowl Champions Vernon Davis and Kyle Arrington, MLB Home Run Champion Luke Voit, World Boxing Champion Butterbean, and NFL veteran Michael Vick.

“Patient safety has always been our first priority, and that hasn’t changed,” said Dr. David Greene, MD, PhD, MBA, Founder and CEO of R3 Stem Cell. “We respect the FDA and are working cooperatively with the agency. We want patients and families to have complete, accurate information when they consider their options. Our licensed provider consultants are extremely knowledgeable in regenerative medicine and spend considerable time with patients explaining options, regulatory status, and information on R3’s IRB Approved Global Observational Safety Database. We remain committed to transparency, to research, and to the patients who trust us with their care.”

R3 Stem Cell’s commitment to safety and evidence is reflected in its research infrastructure, including a first of its kind IRB-approved Observational Safety Database that tracks regenerative patient outcomes and safety. The R3 Stem Cell Research team has authored 17 peer-reviewed publications, including papers on stem cell therapy for Autism, Cerebral Palsy, Premature Ovarian Failure, intranasal stem cell and exosomes, and systemic sclerosis. The most recent 2026 reviews in Frontiers in Drug Delivery, Frontiers in Aging Neuroscience, and Regenerative Therapy focus on mesenchymal stem cells for arthritis, diabetes, and neurodegenerative disorders.

Patients with questions about their care or about this matter are encouraged to contact R3 Stem Cell directly at (844) GET-STEM.

About R3 Stem Cell
R3 Stem Cell is one of the world’s largest provider of regenerative therapies, with more than 80 Centers of Excellence across 8 countries that have performed 30,000 stem cell procedures. Founded by Dr. David Greene MD, PhD, MBA, R3 combines patient care with clinical research and medical education, and its patient-funded programs support free treatment for veterans and ongoing research activities. Learn more at r3stemcell.com.

Media Contact
David Greene, MD, PhD, MBA
R3 Stem Cell Founder/CEO
(844) GET-STEM
info@r3stemcell.com

David Greene, MD, PhD, MBA
R3 Stem Cell
+ +1 844-438-7836
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