The Stem Cells Transplant Institute is a Government Regulated Facility
Costa Rica implemented legislation that legalized stem cell therapy but requires adherence to strict regulations. The Stem Cells Transplant Institute has met all of the formal regulations ensuring strict quality control, safety and excellent patient care.
Due to provision in legislation passed in 2014, the Costa Rican Secretary of Health considered stem cell therapy/regenerative medicine illegal. The bill failed to include any direction around stem cell therapy using adult stem cells but new legislation passed in 2016, Regulation No. 39986 provided authorization and guidance for regenerative therapy using adult stem cells.
Any party that would like to perform stem cell therapy must submit an application to the local Health Controller. The clinic must meet the following formal requirements:
(i) Evidence that the therapy has completed preclinical studies that, as in the case of medications, demonstrate that they are effective and safe for use in clinical practice;
(ii) The complete characterization of the cell types that will be transplanted and their characteristics, cellular processing and production;
(iii) The description of the cells and how they will be administered, including assistive drugs, agents, and surgical procedures;
(iv) A clinical follow-up plan and data records to ensure that the cellular therapy is effective and has no adverse effects; and
(v) Credentials substantiating training in stem cell therapy for the staff who will carry out the procedure.