For the past year or so, I have been including in my Blogs, the possibility of a second Adipose Based Stem Cell Clinical Trial sponsored by the same group as the first stem cell trial completed over 18 months ago. Personalized Stem Cells, Inc. (PSC), for whom I served as one of the co-investigators, has been working on submitting a request for approval of a second Trial to the FDA. About six weeks ago, The California Appellate Court ruled that the use of Adipose-Derived and Cultured Stem Cells falls under the practice of medicine and thus does not require FDA approval. Since that announcement, Personalized Stem Cells has requested and received several legal opinions as to how to proceed outside of the State of California.
At this point in time, PSC is still planning to submit a request for the second phase Clinical Trial to the FDA anticipating that the FDA will ultimately take issue with the California Appellate Court decision. That legal process though is slow and may take years. While this is all taking place, PSC has decided to allow patients to access their stored Adipose-Derived Stem Cells. The financial aspects that will govern said usage are to be announced soon by PSC.
In addition, what I learned last week is that the Adipose-Derived Stem Cells of all participants in the initial clinical trial are in storage and may be available for usage as well as for those who initially paid to bank cells; it is a matter of costs and the latter should be announced soon. In my evidence-based clinical practice of Regenerative Medicine for an arthritic joint, I am able to use the entire spectrum of Orthobiologics starting with Platelet Rich Plasma (A2M, IRAP). At times, it would be more appropriate to use Bone Marrow Concentrate containing Adult Mesenchymal Stem Cells in addition to PRP, A2M, and IRAP. There is also a place for micro-fractured Fat Graft-Lipogems, in appropriate patients obtained by a mini-liposuction. More recently, we have introduced a new technology in biologic medicine termed Extracellular Vesicle Therapeutics that holds promise in improving function and reducing inflammation-generated joint pain.
In order to gain a further understanding of the world of Orthobiologics and Cellular Orthopedics, visit my website at www.sheinkopmd.com. Better yet, call my office and schedule a consultation (847)390-7666.