From Bob Harman, CEO, Personalized Stem Cells:
“In November of last year, I sent a letter to all of you about the Cell Surgical Network (“Berman”) FDA case ruling by Judge Bernal and how this created a unique opportunity to for us to create a pay-for-service business and work with physicians like yourselves to offer treatments to patients of their own cultured cells outside of a traditional clinical study. Since that time, FDA has filed an appeal. Although we believe this process could lead to a broader opportunity, at this present time we believe it prudent not to rely on this ruling for broader use outside of the Central District of the 9th Circuit.
We continue to move forward with our plans to develop a platform for pay-for-service therapy. The most protected method is the Federal Right-to-Try program, implemented as the law of the land in 2017. This program is Federally mandated and runs parallel and separate from all FDA programs and jurisdiction. We will be sending you more detailed information on patient qualification and application for treatment in the coming weeks. We believe this to be a great opportunity to provide needed cell therapy to your patients, including those with cells already stored.
In parallel, we are submitting additional supplements to the FDA to allow us to proceed into cultured cell formal clinical trials. Our filing will be completed in Q1 and we anticipate being able to proceed into a randomized trial in Q2 in knee OA. Following their review and acceptance (30-60 days) of the updates, we will re-initiate the pay-for-service therapy option via the Federal Right-to-Try law and also will initiate the new clinical study.
We know that this delays the ability to get treatments for patients in need, but once the above is completed, we will have a solid platform of continued clinical studies and ability to treat patients in a fee-for-service manner. We continue to believe strongly in both opportunities for treating patients with their own cultured stem cells. We promise to keep you updated and we remain committed to being the best provider of stem cell services.”
For those who do not wish to postpone care for their arthritic joints; who do not meet the inclusion criteria when and if the FDA approves the cultured cell option; or who do not want to partake in a randomized Trial; we have the FDA-cleared Micro-fractured Fat Graft Study. Participants in the Micro-Fractured Adipose Study, wherein the adipose tissue (abdominal fat) is recovered by mini-liposuction as in the Stem Cell Trial for which we are waiting for approval, may do so at a significant discount from the prevailing out-of-pocket costs.
To learn more about how we may help you in the present and in the future, call (312) 475-1893 to schedule an office visit. Visit my website at www.sheinkopmd.com