Regenexx has published the largest safety paper in the world tracking thousands of patients for nearly a decade. The findings show that Regenexx specific protocols are no more dangerous than any other injection. The national registry continues to track patients as far back as 2005, no increase incident of a serious adverse reaction has been seen.
The FDA does not “approve” or “not approve” medical procedures (like gallbladder surgery for example). This is considered a medical procedure.
The Regenexx procedures performed in the United States are compliant with CFR 21 Part 1271 and fall under the same surgery exemption discussed in 1271.15 (b).
All of the Regenexx Stem Cell and Blood Platelet Procedures performed in the U.S. today are same-day procedures that are compliant with CFR 21 Part 1271, falling under the same surgery exemption discussed in 1271.15 (b)
The Regenexx-C Procedure – What’s the Difference?
All of the procedures performed throughout our U.S. Regenexx Procedure Network are same-day procedures. This means that the patient’s cells are harvested in the morning, isolated and processed, then re-injected into the patient’s injured area – all within a period of a few hours. This makes them compliant with CFR 21 Part 1271, falling under the same surgery exemption discussed in 1271.15 (b).
Regenexx®-C is a cultured stem cell procedure that is available only in the Cayman Islands. While our same-day stem cell protocol (described above) is the premier stem cell treatment available in the United States, some patients may benefit from the expanded numbers of cells that are delivered by a cultured stem cell procedure.
The Regenexx-C Procedure, which is only performed at Regenexx Cayman, involves harvesting the cells on the patient’s first visit, growing them to larger numbers over approximately several weeks, testing the cells, then re-injecting the cells during the patient’s second visit.
The basic science on adult stem cells shows that if the cells are kept in culture for short periods, there is no risk of the cells becoming cancerous. We have published the world’s largest (to date) safety and complications tracking study of adult stem cell use in patients. This study did not show any serious stem cell related complications and it did not show that any patient developed a stem cell-related cancer. Finally, we maintain an extensive complications tracking database with patient contacts at specified times. We have seen no evidence of significant complications at these re-implant sites. We also work with an outside lab for quality to clear each patient’s cells before they are used in treatment as an additional safety check.
No, an analysis of the published research shows that liposuction is riskier than a bone marrow aspirate. However, this has usually been done in the context of a plastic or reconstructive surgery. The Mini-Lipoaspiration that is used for injecting fat grafts or Microfragmented fat tissue for cushion and support from the same patient in the same day is likely quite safe. The total quantity of fat removed for this procedure is quite small in comparison to a traditional lipoaspiration. And in our experience, has been very safe.
Using the HHS OHRP guidelines for complications reporting, our complications to date have been in the mild to moderate category and rare. This means that either the complication (like transient swelling) required no medical treatment (Mild), or if it did require medical treatment, the treatment was simple (Moderate-like a patient who failed the procedure who ultimately decided to get the knee replacement that he or she was planning before the procedure). We have published the world’s largest (to date) safety and complications tracking study of adult stem cell use in patients. This study did not show any serious stem cell related complications and it did not show that any patient developed a stem cell-related cancer. In addition, our most recent safety paper was named the best of its type by a meta-analysis that appeared in the prestigious medical journal, Osteoarthritis, and Cartilage.