International Society Creates Global Program to Evaluate Stem Cell Clinics

Nonprofit builds accreditation process to facilitate the advancement of cell based medicine and ensure patient safety.

PORTLAND, OR, February 4, 2011 – In response to the unprecedented proliferation of non US-based stem cell clinics and the continued growth of patients traveling abroad to seek innovative cell based therapies,  the International Cellular Medicine Society (ICMS) announced today a new Stem Cell Clinic Accreditation Program.  The Society, an international medical nonprofit organization dedicated to patient safety, physician education, and peer oversight of cell based medical therapies, developed this program to bring transparency to these medical procedures.

“With over 200 clinics currently offering stem cell therapies globally, the need for accreditation and transparency has never been greater,” said David Audley, Executive Director of the ICMS. “Without basic standards and a method to evaluate clinics and treatments, patients and their physicians have no way of making an informed health care decision.” The ICMS has identified nearly a dozen clinics to participate in the program.

Participating clinics will undergo a rigorous evaluation over the course of 18 to 24 months. The accreditation consists of a detailed ten-step process that includes the review and evaluation of the clinics’ entire practice. This will include an assessment of informed consent procedures, patient candidacy guidelines, clinical and lab processes, and treatment protocols by an Institutional Review Board. Clinics are also required to participate in the ICMS Treatment Registry and have the outcomes and complications of all treated patients tracked by the ICMS. Additionally, clinics must undergo a series of extensive on-site evaluations conducted by the ICMS to review the clinics’ practices, patient data collection, and complaint adjudications, as well as a laboratory audit conducted by an independent, 3^rd party vendor. Combined, this process is the most thorough and complete evaluation of cell based medical clinics in the world.

Clinics interested in participating in the program must submit an initial application that includes the conditions they are treating, an explanation of the treatment process and protocols, as well as the qualifications of the treating physicians.  This application will be reviewed and approved by the ICMS Medical Board before a clinic moves forward in the process. “This is the first global accreditation process for cell based medical therapies,” Audley stated, “Patient s should be very wary of any clinic that refuses to submit to peer review, independent data evaluation, and real transparency standards.”