Between vacations, holidays, developing an algorithm for a new clinical trial, while at the same time credentialing for the FDA Personalized Stem Cell Clinical Trial, I ran out of time so I haven’t been blogging as usual. All this while, I continue to practice Regenerative Medicine.
As we approach 2020, the discipline of Regenerative Medicine will change as the cells and options available will be classified as drugs. What will hopefully take place is a restoration of the public trust in Regenerative Medicine given the harm done by those promoting birth product as a source of stem cells.
When a patient would attend an advertised seminar, pay a relatively large amount of money without an examination or review of images only to receive dead cells, those of us practicing evidence based Cellular Orthopedics were faulted along with the Charlatans and Camp Followers even though we weren’t part of the scam. In 2020, point of service care will be overseen by federal regulations with reclassification of autologous tissue and cells injectables as drugs so that IRB oversight and FDA clearance will be necessary to maintain a practice.
My particular role will be as a clinical investigator in the Personalized Stem Cell Clinical Trial for which our credentialing will have been completed on Thursday. It will have been the most highly regulated process in the world of Regenerative Medicine ever undertaken and I am thrilled to be part of it. At the same time, I am partaking in the design of another trial for a different regenerative approach directed to those who do not meet the inclusion criteria for the Personalized Stem Cell Trial. We have completed safety and efficacy preliminary follow-up on 20 patients who received the alternative option which is a pain blocker and anti-inflammatory but does not have regenerative potential.
To learn about the Personalized Stem Cell approach, visit PersonalizedStemcells.com. To see your options if you don’t meet the inclusion criteria for PSC, follow this Blog.