CSO Blog: US Stem Cell Clinic Response to FDA Warning Letter

Dear shareholders and friends,

The U.S. Food and Drug Administration posted a warning letter issued to US Stem Cell Clinic (USCC), a privately-held Florida LLC in which US Stem Cell, Inc. has a 33% Member Interest.  USCC, in our estimation, is a leader in novel regenerative medicine solutions and physician-based stem cell therapies for patients. USCC released the following statement in response to the FDA’s letter:

“The safety and health of our patients are our number one priority and the strict standards that we have in place follow the laws of the Food and Drug Administration. Since November 2014 we have offered the FDA unrestricted access to our facilities and our processes and will continue to work with them as it pertains to clinical and industry improvements. The FDA has stated that they will have specific stem cell guidelines by the 21st Century Cures Act deadline of December 13, 2017 and we intend to follow those standards as well.

We believe that we have helped thousands of patients harness their own healing potential.  It would be a mistake to limit these therapies from patients who need them when we are adhering to top industry standards.”

USCC has issued a response to the FDA (read the full letter here) and we are looking forward to their response.  Management contends that the clinic is completely compliant with medical board requirements of sterility for clinics.  The statements by the FDA regarding the sterility of our facility, in our opinion, are misleading since the requirements for GMP facilities are very different.  It is our sincerest interest to adhere to the FDA’s interpretation of the laws and have several specific questions that we have asked the FDA to kindly provide answers.  We have also specifically requested a meeting with the FDA commissioner to better explain the procedures that have successfully helped thousands of people.

I would like to thank everyone for the huge outpouring of support.  We will continue to fight for the rights of patients to harness their own healing potential.  I am honored to represent this technology and this company and I know that we are on the right side of history.  I have personally witnessed the power of regenerative medicine and as I have said before, I will always stand up for the rights of patients.

The FDA has included a link to ask patients to report concerns.  We would like to encourage patients to come forward using the same link that the FDA has issued to describe their positive experiences.  We know that thousands of patients have had excellent outcomes and the FDA should hear about these outcomes as well.

Warmest regards,

Kristin Comella