For Immediate Release 

 

U.S. STEM CELL CLINIC ACKNOWLEDGES WARNING LETTER BY THE FDA AND RESPONDS

Sunrise, FL – August 28, 2017 –The U.S. Food and Drug Administration today posted a warning letter issued to US Stem Cell Clinic (USCC), a privately-held Florida LLC and 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 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.”

 

ADDITIONAL BACKGROUND INFORMATION

  • US Stem Cell Clinic will and does abide by all of the FDA’s requirements and will switch to 510(k) approved systems to process tissue in-clinic such as bone marrow and/or fat systems while we work with the FDA to establish protocols going forward.
  • 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 as well.
  • USCC has never had a breach of sterility and our facility has demonstrated sterile surgical techniques as required by the state medical boards.
  • USCC is not manufacturing a drug and therefore medical clinics are not required to follow cGMP.
  • USSC will also reply to the FDA’s warning letter (dated August 24, 2017) within the 15-day allotted period.

Although many statements in the FDA letter are generalized towards bad-actors in our industry and not related to USCC, USCC felt compelled to reply above to the statements related to our company.

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.

For testimonials from some of the patients who have been treated at U.S. Stem Cell Clinic, please visit: http://usstemcellclinic.com/testimonials/