If you access www.ClinicalTrials.gov, a service of the U.S. National Institutes of Health, next week, you will learn of a new clinical study concerning measurement of outcomes in the minimally invasive treatment of knee arthritis. Adult Mesenchymal Stem Cells derived from Bone Marrow that are concentrated and prepared using updated technology is the basis for Regenerative Sciences, LLC Center sponsoring the Trial. The other reason, about six months ago, I changed the discussion concerning outcomes measurements of cellular orthopedics interventions for knee arthritis when I compared my results at one year of stem cell regenerative therapy with my historical results of knee replacement surgery. That paper, delivered at an international stem cell conference, while changing the discourse in the regenerative medicine world, also catalyzed argument among the joint replacement surgeons about the role of stem cells for arthritis of major joints. One valid criticism of my scientific clinical trial was that there had only been a one-year follow-up. The second, a relatively low number of patients in that first of its kind study. The net result is an approval announcement from the Institutional Review Board of the International Cellular Medicine Society: Randomized Controlled Trial of Regenexx SD Versus Exercise Therapy For Treatment of Knee Osteoarthritis with Historical Comparison To Total Knee Arthroplasty.
As in any clinical trial, there are inclusion criteria that must be met before a patient would be considered a candidate for the stem cell intervention. The study itself has IRB restrictions as well. Beside the many benefits of cellular orthopedics for osteoarthritis of the knee, just as anything else in health care, there are Risks and Discomforts. You may become familiar with The Regenexx SD procedure by accessing that web site www.Regenexx.com or when you are seen in my office. There are no experimental tests or procedures in this study. Before a candidate gains entrance to the study, the following procedures are required to evaluate eligibility:
- A knee examination
- Documentation of medical and surgical history and medication usage
- Review of current images (X-rays)
Costs
While there will be no charge for the Pharmacologic portion of the trial (Stem Cell management), study participants or their insurance may be billed for:
- The initial physical evaluation/consultation
- Follow-up office visits after the procedure
- Knee brace if requested
Are you interested and do you meet the inclusion criteria? To learn more call 1-888-525-3005 or contact [email protected]
Tags: arthritis, Clinical Trial. Mitchell B. Sheinkop, Knee, Knee Pain Relief, Orthopedic Surgeon, Osteoarthritis, Regenexx-SD