International Stem Cell Association Responds to Clinic Closure in Costa Rica
PORTLAND, OREGON, June 4, 2010 – The International Cellular Medicine Society (“ICMS”), a professional medical nonprofit organization dedicated to patient safety through the advancement of safe and effective adult stem cell therapy, applauds the efforts of governmental agencies and nonprofit organization to bring greater transparency to the practices of international stem cell clinics. The ICMS asserts that only through the independent collection and validation of patient outcome data can the promise of adult, autologous stem cell therapies be realized.
“Through its closure of the Institute of Cellular Medicine,” says David Audley, Executive Director of the ICMS, “the Costa Rican Ministry of Health has exposed one of the greatest potential risks of medical tourism: treatments being offered to desperate patients without data to support their claims of efficacy or safety.” The risk to patients is not just that the therapies may not work, but that some ‘offshore clinics’ provide little or no complications tracking. The ICMS has sought to address this potential patient safety risk with the implementation of its Open Treatment Registry. This registry of patient reported data is collected and managed by the ICMS and provides prospective tracking and follow up of patients for 20 years.
The ICMS approached the Institute of Cellular Medicine in San Jose, Costa Rica about participation in the Registry. While the ICMS was able to get sufficient data to include the clinic in the Society’s annual Offshore Stem Cell Clinic Report, the clinic did not respond to the ICMS inquiries about participation in the Open Treatment Registry.
Participation in the Open Treatment Registry is reserved for those clinics who have applied to the ICMS and whose basic cell processing and delivery methods have been evaluated for patient safety by a volunteer board of academic and clinical researchers. “We believe that participation in the Registry is an indication that a clinic has nothing to hide. While the ICMS does not sanction these clinics or certify their treatments, these are the clinics that are taking appropriate and reasonable safe guards for patient safety.”
The decisive action of the Costa Rican Health Ministry provides an additional example of the need for greater peer review and oversight within the cell based medical therapy community. Through its own best practice guidelines, the ICMS hopes to provide health ministries and their officers with a structure to evaluate the clinical and laboratory practices of stem cells clinics. These guidelines, developed by panels of international health care practitioners and research scientists, provide the most comprehensive and up to date standards on the collection, processing and re-implantation of adult, autologous stem cells.