mattjeacock /
4 July 2017Medtech

Stem cells in Costa Rica: a boost for medical research

Regenerative medicine allows the application of experimental therapies using adult stem cells to treat various diseases that so far have been incurable. This branch of medicine has been promoted by the knowledge that stem cells have the ability to become cells of different tissue that the body uses for self-repair. Scientific research has shown that these cells have the potential to regenerate organs and other body tissue.

In 2014, Costa Rica enacted the Biomedical Research Statute, No. 9234, after a drawn-out period of uncertainty for the medical community that had left the country deprived of the gains from foreign and local investment and the subsequent benefits for patients that comes from medical research. Today, the country is benefiting from a rising market of companies and individuals seeking to move their clinical trials to Costa Rica as a result of the business-oriented provisions contained within the statute, as well as the support of local authorities.

One of the flaws of the statute was its omission of the application of regenerative therapies using adult stem cells. The Costa Rican Secretary of Health had considered that under the provisions of the statute these regenerative therapies were illegal.

However, aware of the current developments in science and the benefits of regenerative therapies, the Costa Rican President and the Secretary of Health secured a decisive political victory at the end of 2016 by implementing Regulation No. 39986 on the Authorization for Regenerative Therapy Using Adult Stem Cells. This resulted in a dramatic shift in public health policies coming from a nation that banned in-vitro fertilisation for more than a decade and declared that clinical trials were against the Constitution for several years.

Formal requirements

Under the new section 2, the regulation provides that “no official authorisation is required for transplants of progenitor cells obtained from peripheral blood or transplants of haematopoietic cells obtained from umbilical cord blood when they are indicated for treatment of acute myeloid or lymphoid leukaemia, chronic lymphoblastic or myeloid leukaemia, Hodgkin or non-Hodgkin lymphoma as the more frequent causes or to a lesser degree for severe aplastic anaemia, nocturnal paroxysmal haemoglobinuria, immune system diseases, some haemoglobinopathies, hereditary metabolic diseases, as well as multiple myeloma and some solid tumours”.

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