“They are close to reaching the max number in the study and feel they have enough data at this point.”
While we still could offer adipose derived stem cells to patients via Liposuction and processing of the adipose tissue to recover millions of stem cells, the procedure will revert to fee for service. In the post PSC Trial treatment protocol, it would be possible to address several joints in the same setting with adipose derived cells. Owing to the changes in the PSC Trial protocol necessitated by the COVID-19 virus mandated quarantines, the FDA has diminished the number of patients needed to be enrolled. While I have not yet harvested the adipose tissue from all current enrollees, nor have I injected the stem cells in those already having gone liposuction, we will be done harvesting and delivering the stem cells by mid-summer and have done our part.
Personalized Stem Cells Trial Update
At the beginning of the Trial last August, PSC became the first FDA approved clinical trial in the United States allowing the seven investigative sites to create a drug from a patient’s tissue for the treatment of arthritis. As it stands now, all biologics will be reclassified as drugs by the FDA as of November, 2020 and Personalized Stem Cells became the leader in this endeavor. It will not be for another six months that our team of seven clinical trial sites will have the necessary outcomes data required which would allow the FDA to reclassify the stem cells recovered from your adipose tissue as an approved drug.
On another note, yesterday, Northwestern Memorial Hospitals announced a “successful double lung transplant” to treat a young patient whose lungs were destroyed by the the COVID virus. In a previous Blog, I had introduced the PSC initiative to treat COVID pneumonia with adipose derived stem cells. That trial is underway in San Diego. One of the advantages enjoyed by those who are enrolled in the knee arthritis trial is storage of their stem cells. Those stored cells are available to enrollees for the future care of an arthritic joint in addition the study knee; but as well, for systemic disease outside of the musculoskeletal system such as COVID pneumonia. There are stem cells harvesting and storage companies cropping up on the internet; but as of this time, only Personalized Stem Cell, Inc.is allowed to treat. Should this pandemic continue, a patient at risk, be it age related or health related, for COVID complications just might contact our office and arrange for a fat graft harvest and storage of those adipose derived stem cells to meet a future need.
To schedule a consultation for the care and treatment of your symptomatic joint with limited function, call (312) 475-1893. You may visit my web site and watch my Blog at www.sheinkopmd.com To learn more about Personalized Stem Cells and the COVID lung trial, visit PersonalizedStemCells.com
Tags: clinical trials, personalized stem cells, stem cell clinical trial