Due to the Federal District Court ruling in the CSCTC/CSN case in August of this year, it appears that FDA has no jurisdiction in autologous adipose cell therapy, including cell culture expanded cells. Many questions on interpretation so here is the link to the ruling to provide you easy access to read for yourself:
Our office will be communicating with you concerning your interest in pursuing the cultured stem cell option for an arthritic joint.
1. Patients with stored doses ready to use
a) After decision to provide treatment, in conjunction with your patient, you can place an order for the number of doses needed and date to treat.
2. Patients with stored culture starter cells
a) These patients do not have cells ready to use and must place order for cell culture expansion (“StemReady”) to manufacture the cells. Cost for past trial patients is $7,500 and for a new patient is $12,500
Physicians’ invoices for all medical services rendered, including but not limited to lipoaspiration, diagnostics, examinations, office fees, laboratory fees other than PSC, stem cell administration and any additional medical services provided.
PSC directly contracts and invoices the physician’s patients for laboratory processing services and cell banking fees per this schedule.
The Fee Schedule is that of PSC and Stem Ready. There is a professional fee that is additional and generated by my office. For those interested, the fee schedule is far less than what is usual and customary when travelling off shore for Stem cells.
To learn more or schedule a consultation, call: (312) 475-1893. You may visit my web site at www.sheinkopmd.com. The Personalized Stem Cell web site is www.personalizedstemcells.com.