R3 Medical Companies
FDA issued a warning letter to R3 Medical Companies (CEO David L. Greene, M.D.) in Scottsdale, AZ, citing that its umbilical cord-derived and cord blood products—ReBellaWJ, ReBellaXO, ReBellaXOL, and ReBellaCB—are unapproved new drugs and unlicensed biological products marketed for treating conditions such as arthritis, neurological disorders, autism, diabetes, and erectile dysfunction without an approved BLA or IND. The agency also documented significant CGMP violations at co-located Bello Bio and Regen Suppliers facilities, including failure to validate aseptic processes, lack of stability testing, and inadequate quality control procedures. FDA noted this is a repeat concern, having previously notified Greene in 2019 about similar nonhomologous stem cell therapy marketing. The letter warns that failure to adequately respond may result in seizure and/or injunction.
Flagged claims (9)
ReBellaXOL Lyophilized Exosomes… produces collagenesis, anti-scar, pro-angiogenesis, & anti-apoptosis. BelloXO intensely stimulates regeneration…
Exosome Therapy for Joint Pain… Exosome therapy is getting great results for joint pain relief:… Rebuilding cartilage: Exosomes help fix damaged cartilage… Reducing inflammation: They calm the swelling in your joints.
ReBellaXO an exosome allograft derived from Wharton's Jelly MSCs... For your procedures involving IV's, joints, soft tissue, hair, facial or sexual rejuvenation, ReBellaXO represents your most cost effective and safe option for fitting regenerative biologics into your patient care!
These are your stem cells. There's 30 million in each vial... This is ReBellaXO. These are your exosomes… Those are very anti-inflammatory...
R3 Anti-Aging and Medspa in Scottsdale and Nashville offers umbilical cord allograft therapy for patients who have joint or soft tissue pain...In addition, the umbilical cord tissue contains a significant amount of growth factors, exosomes, mesenchymal stem cells and cytokines as well. These facilitate one's body to amp up the repair and regeneration activities to reduce pain from joint degeneration, tendonitis, bursitis...and neuropathy.
In the research literature and from our provider's experience, there are benefits being shown for: Neurologic Conditions…Heart/Kidney/Lung Failure (e.g. Cardiomyopathy, COPD)…Autism…Cerebral Palsy…Diabetes…Lyme Disease...SI Joint Pain...Erectile Dysfunction..
Can exosomes help with neurodegenerative conditions? Research has shown that exosomes can penetrate the blood-brain barrier and stimulate neuronal differentiation, growth of neurons, and reduce inflammatory processes within the brain tissue. This may result in future benefit to neurodegenerative conditions such as Alzheimer's, Parkinson's, Post Stroke and other issues.
For years now, umbilical cord blood has been used increasingly for non-malignant conditions such as arthritis, neurological conditions, autism, diabetes, liver/kidney failure and much more. Umbilical cord tissue has a ton of hematopoietic and mesenchymal stem cells along with cytokines, growth factors, and exosomes. All of this makes it very effective for these conditions.
One of the major effects is the reduction of inflammation. Chronic inflammation has been shown to be present in the body and is a known precursor to many medical conditions including organ failure, arthritis, several types of cancer and more. The biologic's cells are able to systemically reduce this inflammation…
Required actions (2)
Please submit your response in writing within fifteen (15) working days from your receipt of this letter, outlining the specific steps you have taken or plan to take to address any violations and prevent their recurrence.
Failure to adequately address these matters may result in action without further notice including, without limitation, seizure and/or injunction.
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