Readers of this Blog are aware of my having been credentialed for the first ever, FDA approved, Clinical Trial allowing the use of stem cells, retrieved from your own adipose tissue, in the care and treatment of arthritis. Until now, although heavily advertised, it has not FDA compliant to separate stem cells from your bone marrow or fat and use the cells for injection into an arthritic joint. Concentration has been allowed but not separation, storage or culturing. Two months ago, Personalized Stem Cells receive FDA approval to credential several centers in the country to begin recruiting patients for a mini liposuction, separation of the stem cells from the fat, and injection of the resulting millions of cells into the arthritic knee. Detailed information is available on my web site, sheinkopmd.com or at the personalizedstemcells.com site. Bad actors and Camp Followers advertised that they could provide stem cells but they were charlatans; as of October 1, Google will no longer run those adds. The truth be known, the only approved means of delivery stem cells was though concentrating your bone marrow after aspiration. Now we have another option, using the stem cells derived from your adipose tissue via a proprietary, patented FDA compliant processing methodology.
As of today, we have screened seven interested patients for The Clinical Trial. It is a complex process and time consuming to make sure that the patient meets the inclusion criteria for The Trial. Then comes the informed consent process which is very comprehensive. The first patient has gone through the Prescreening and the Screening after having met all inclusion criteria; his procedure is scheduled in two weeks. The second patient underwent the Prescreening process and now is completing X-rays and laboratory studies in preparation for the Screening visit. Over the next two weeks, the others will be prescreened, screened, receive comprehensive informed consent; and assuming all requirements are met, scheduled for the procedure.
Future Clinical Trials Under Consideration
- PSC plans to apply for clinical trials to treat multiple orthopedic conditions including knees, hips, and shoulders. More specific information will be posted as applications are submitted and/or approved.
- PSC plans to apply for clinical trials to treat Traumatic Brain Injury (TBI). More specific information will be posted as applications are submitted and/or approved.
- PSC is collaborating with physicians and academic institutions to develop stem cell treatments for medical conditions that currently have few treatment options.
To schedule a consultation in my office, call (847) 390-7666. To learn more about the FDA approved Clinical Trial call (312) 475-1893.