General
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). Unfortunately, there still remains some confusion about Regenexx, largely as a result of a few individuals who have written about our case against the FDA throughout the last few years, but who did not fully understand that the case relates only to the Regenexx-C Procedure. This single procedure, which is different from the procedures now performed in the USA, is only available in the Cayman Islands through an independent vendor who has licensed the procedure and has not been performed in the U.S. since August of 2010.
All of the procedures performed in Colorado and 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. 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 two weeks, testing the cells, then re-injecting the cells during the patient’s second visit.
Dr Chris Centeno explains the FDA’s stance on the Regenexx-C cultured stem cell procedure, which has not been performed in the United States since 2010 (currently offered by Regenexx Caymen):
[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.]
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). Click the toggle above for full details.
No. PRP is concentrating platelets in the blood, not stem cell therapy. This is a more detailed discussion on the differences between PRP and stem cell therapy. In addition, while PRP is one component of the therapy, we use a very different “Super Platelet Mix’ which we believe helps to produce many more stem cells.
We do offer the Regenexx-SCP procedure, which is a platelet procedure which is quite different from the bloody PRP available through commonly used bedside centrifuges. To see a patient infographic on these differences, see this link for general info on the Regenexx-SCP platelet procedure and this one for a comparison between SCP and bedside PRP machines.
Conditions Treated, Success Rates
Fractures that have failed to heal, joint cartilage problems, partial tears of tendons, muscles, or ligaments, chronic bursitis, avascular necrosis of the bone, and lumbar disc bulges.
Top Questions About Regenexx
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 many things that set Regenexx procedures apart from all other stem cell therapy being offered is dosage; to ensure the best possible outcome the doctor takes many factors into consideration, including your stem cell count.
Our registry based research has shown that, for stem cell procedures, older age does not adversely impact outcome.
That depends on which procedure is performed.
For example, for knee arthritis, you can expect 3 days of significant down-time followed by a slow return to normal activities over 6 weeks. While you may be asked to wear a brace, very few of our procedures require crutches.
The same day procedure involves taking cells and then isolating those over one day.
The cultured procedure grows those cells to larger numbers over a period of a few weeks.
Many mechanisms have been put forth, including long-term blocking of cells that destroy the joint, rescue of cells that fix the joint, and replacing lost native stem cells that maintain the joint.
No, while we have seen MRI evidence of cartilage growth in mild and moderate arthritis, we generally don’t see it with severe arthritis.
Because the procedure protocol will vary from person to person and because each person will have a unique condition to be treated, the pricing of procedures can vary considerably from patient to patient. An evaluation will give you a better idea of condition, treatment and costs specific to your condition. The chart below provides a general idea of the procedures and where they fall in terms of cost and severity of conditions treated. Platelet procedures cost considerably less than stem cell procedures.
No, these procedures are too new to be covered yet. Don’t let someone fool you, PRP and stem cell injections have no insurance coverage at this time.
Some health insurance plans may cover the initial evaluation. If your plan does, and we are part of your insurance carrier network, we will bill the carrier. If not, there will be a consultation fee for the initial face to face consult.
We recommend that you contact your insurance carrier for more information about your specific coverage details.
No. PRP is concentrating platelets in the blood, not stem cell therapy. This is a more detailed discussion on the differences between PRP and stem cell therapy. In addition, while PRP is one component of the therapy, we use a very different “Super Platelet Mix’ which we believe helps to produce many more stem cells.
We do offer the Regenexx® Super Concentrated Platelet Rich Plasma Procedure, which is a platelet procedure that is quite different from the bloody PRP commonly available using bedside centrifuges. To see a patient infographic on these differences, see this link for general info on the Regenexx platelet procedure and this one for a comparison between our process and typical bedside PRP machines.
When Regenexx® first began offering orthopedic stem cell therapy in 2005 as part of an IRB approved medical study, we were one of the few clinics in the world treating orthopedic problems with stem cells. When we began treating everyday patients in 2007, this was still the case. Now other clinics are beginning to offer basic cell therapies, most in plastic surgery and cosmetics, with a few clinics just starting to try orthopedic therapies. While we welcome the growth in cell based medicine, we also know that we’re world leaders in this area. As leaders, we set a higher standard for ourselves in all of the cell-based procedures we offer our patients.
Further Information:
