Costa Rica looks to be stem cell treatment destination

 

The Regulation to authorise regenerative therapy using adult stem cells is Bylaw number 39986-S.  The Regulation identifies three different categories of regenerative stem cells therapies that are legal in Costa Rica, and the process of obtaining the specific permits to operate such therapies.

Category 1

Progenitor cell transplants obtained from peripheral blood or haematopoietic cell transplants obtained from umbilical cord blood do not require authorisation from the Health Authority, when used for the treatment of acute myeloid or lymphoid leukaemia, chronic lymphocytic or myeloid leukaemia, Hodgkin’s lymphoma or non-Hodgkin’s lymphoma, severe aplastic anaemia, paroxysmal nocturnal hemoglobinuria, immune system diseases, some hemoglobinopathies and hereditary metabolic diseases, as well as in multiple myeloma and in certain solid tumours.

Category 2

Therapies whose stem cells are exposed to more than minimal manipulation need authorisation from the Health Authority.

Clinics must provide: 

  • Evidence that the therapy has completed preclinical studies that demonstrate that it is effective and safe for use in clinical practice. 
  • The complete characterisation of the cell types that will be transplanted and their characteristics, cellular processing and their production.
  • A description of how the cells will be administered, including adjuvant drugs, agents and surgical procedures.
  • A clinical monitoring plan and data records to ensure the effectiveness and adverse effects of cell therapy.
  • Original and copy of the title or certificate stating the training on stem cell therapies of the personnel who will perform the procedure.

Category 3

Those therapies with adult stem cells need to be authorised by the Health Authority that are for exclusive autologous use, for regenerative purposes and where cells are exposed to minimal manipulation.

Clinics must provide: 

  • Scientifically reasoned justification that this procedure has a reasonable chance of success, including any preclinical or clinical evidence of proof of concept, of its efficiency and safety. 
  • Clinical justification of the reason why this proposal for stem cell treatment should be implemented compared to existing treatments.
  • The complete characterisation of the cell types that will be transplanted and their characteristics, the process and their production.
  • A description of how the cells will be administered, including adjuvant drugs, agents and surgical procedures.
  • A clinical monitoring plan and data records to ensure the effectiveness and adverse effects of cell therapy.
  • Original and copy of the title or certificate stating the training in stem cell therapies of the personnel who will perform the procedure.

Most medical tourists to Costa Rica are from the USA, where the rules on stem cell treatment are much tougher. While Costa Rica may want to attract stem cell medical tourists, most Americans going to Costa Rica currently seek dental treatment. 

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