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.
View the current safety data for our procedures.
Regenexx procedures are exempt from FDA regulation.
Each of the Regenexx procedures available in the United States involves the patient’s own bone marrow or blood, and the Regenexx network of doctors only treat musculoskeletal conditions. Further, none of the Regenexx procedures available in the United States involves the culture expansion of the patient’s cells to create larger number of cells. Thus, the Regenexx procedures available in the United States generally fall into the following regulatory exemptions:
- For our procedures involving concentrated bone marrow, minimally manipulated bone marrow for homologous use is not subject to FDA regulation as a human cell, tissue, or cellular or tissue-based product (HCT/P); 21 CFR 1271.3(d).
- For our procedures involving autologous blood (such as PRP), practitioners who are licensed by law to prescribe or administer drugs and who manufacture blood products solely for use in the course of their professional practice are not subject to FDA regulation; 21 CFR 607.65.
- Procedures involving the removal of an HCT/P from a patient and the implantation of that same HCT/P back into the same patient during the same surgical procedure are not subject to FDA regulation; 21 CFR 1271.15(b).
Regenexx is proud of its history of regulatory compliance and is deeply familiar with the regulatory environment in which it operates. If you have any questions about our regulatory compliance, please feel free to ask and we will be happy to speak with you in further detail.
[Disclaimer: The Regenexx® same-day procedures are performed in the United States. The Regenexx-C cultured stem cell procedure is only offered outside the U.S. through independently owned and operated medical services providers operating exclusively in countries that allow autologous cultured cells to be used through their local regulatory structure. These service providers are not part of nor affiliated with the Centeno-Schultz Clinic nor any U.S. Regenexx Network provider. The Regenexx-C procedure licensed by these entities is not approved by the U.S. FDA for use in the United States.]
We originally conducted clinical trials from 2005 – 2007, which were the first orthopedic stem cell procedures performed. Since that time, Regenexx has performed more of these procedures than any other clinic or medical group. The same-day procedure that is currently performed in the United States was developed in 2010 and has been continually improved since that time.
We do. We have been collecting patient outcome data for quite some time and we regularly and openly publish the results with the public. To view this data, visit our Outcomes Page.
About as painful as a typical shot in a doctor’s office.
You can walk right out of the clinic the same day any procedure is completed. The entire process will take anywhere from 2-8 days depending on the doctor’s recommendation.
We use real-time x-ray known as fluoroscopy or musculoskeletal ultrasound. Your MRI images are used to help plan that injection.
All of our patients walk out of the clinic. However, having someone drive you for a medical procedure is never a bad idea. On occasion, a local nerve block may be used, which could impair your ability to drive safely, so you should consult with your doctor or clinic about your specific treatment and protocol to ensure that it will be safe for you to drive if you wish to do so.
This is on a case-by-case basis and although we have before, it would be at the advice of the doctor to treat more than one area. One of the key things that set Regenexx procedures apart is dosage. To ensure the best possible outcome the doctor takes many factors into consideration, including your stem cell count. Click here to learn about conditions treated.
Our registry-based research has shown that, for stem cell procedures, older age does not adversely impact outcome.