Safety/Compliance FAQs

Regenexx® has tracked thousands of stem cell procedure patients for almost 10 years, resulting in the world’s largest safety paper on the subject. The results indicate that our specific protocols are just as safe as any injection procedure. A national patient registry started in 2005 and still in use, also shows no increases in negative reactions from our stem cell procedures.

The FDA doesn’t have jurisdiction over medical procedures, and Regenexx procedures are classified as medical procedures.

However, our Stem Cell and Blood Platelet Procedures that are conducted in the United States do comply with CFR 21 Part 1271 and are exempted from surgical classification in 1271.15(b). 

What is the Regenexx-C Procedure?

Because all the Regenexx procedures performed in the United States are completed within one day – from extracting the patient’s cells to processing them to reinjecting them – they are considered compliant with CFR 21 Part 1271 and exempt from surgical classification, as discussed in 1271.15 (b).

We do offer a more complex procedure, Regenexx-C, which takes place over the course of several weeks, rather than one day. During this procedure, the patient’s cells are harvested, then propagated in a lab for a period of weeks, tested and finally reinjected into the patient at the second visit. It is only available in the Cayman Islands at this time because the FDA classifies this procedure as a drug.

VIDEO: Regenexx in the Caymans

Adult stem cells that are kept in culture for a brief period of time don’t carry a risk of becoming cancerous. Regenexx also has published the largest safety study in the world regarding adult stem cell procedures’ safety and complications. None of our patients reported any significant stem cell-related complications or cancer related to their stem cell treatments. Lastly, we keep a database that tracks patients’ complications, and the collected data has shown no serious side effects at the patients’ re-implant areas. As an added precaution, we contract with an outside laboratory that tests each patient’s cells to ensure they are not diseased in any way before we use them in treatment.

Published research indicates that a bone marrow aspirate is safer than liposuction, but the majority of liposuction procedures in these studies were conducted as part of reconstructive or plastic surgery. The same-day procedure we use, a mini-lipoaspiration, to add fat grafts or microfragmented fat tissue to a patient’s problem area is probably very safe. This is because the amount of fat we extract and reinject is very small compared to that used in a traditional lipoaspiration.

Based on the Department of Health and Human Services Office for Human Research Protections (OHRP) guidelines, we have had few reported complications, and these were in the mild to moderate categories. For example, short-lived swelling in the treated area required no medical attention and is considered a mild complication. A moderate complication is a patient whose procedure did not resolve the issue and said patient opted for a knee replacement, which was planned before receiving our treatment.

Regenexx has published the largest safety and complications tracking study of adult stem cell usage in patients in the world. This does not show stem cell-related cancer or any other significant complications. Plus, the well-respected, peer-reviewed medical journal, “Osteoarthritis and Cartilage,” deemed our latest safety paper the best of its type using a meta-analysis. 

We have been collecting data on our patients for about 14 years and continue to follow up with our patients. So far, no one has contracted stem cell-related cancer as a result of our procedures.