ICMS Publishes Regulations for Medical use of Stem Cells in Mexico
FOR IMMEDIATE RELEASE
International Cell Medicine Society Publishes National Guidelines for Medical Use of Stem Cells in Mexico
PORTLAND, OREGON – Friday, March 2, 2012. The International Cellular Medicine Society (ICMS), a professional medical association dedicated to patient safety through the strict evaluation of cell-based therapies and the rigorous oversight of medical facilities and clinics has published an overview of the regulations for the medical use of stem cells in the United States of Mexico.
In Mexico, as in much of the rest of the world, the topic of progenitor cells or stem cells is still under review. Recent congressional actions in Mexico have introduced the issue of stem cells into our national health laws. Although it has been given full recommendation by the Senate Health Committee, it is scheduled for a full vote early March, 2012.
From those Health Committee recommendations we get the following:
The use of embryonic progenitor cells is strictly forbidden for therapeutic, educational or research use, regardless of its origin.
In the case of the therapeutic use of hematopoietic progenitor cells derived from placental blood or bone marrow, use will be limited to hematological (blood) diseases.
All cases of use of hematopoietic progenitor cells derived from placental blood or bone marrow, other than therapeutic or educational, shall be considered for research purposes.
Those cases considered for research purposes must be subjected to the established rules set by the General Health Code as it pertains to health research, under the sanitary supervision of COFEPRIS in coordination with the National Center for Blood Transfusion (CNTS).
Sections 41 Bis, 98, and 315 of the General Health Code stipulates that all establishments must possess the following authorizations and/or permits:
Sanitary license and responsible physician.
Organ, tissue and cell bank license.
Bioethics, Biosafety and Research committees.
In the case of research use, the head researcher must submit the research protocol to consideration by hospital committees, in accordance with the General Health Code as it pertains to the matter of health research.
The internment or export of organs, tissues, blood, its components or derivatives to and from the national territory without the express permission of the National Health Authority, through COFEPRIS, is strictly forbidden.
In the cases where allogeneic placental blood-derived progenitor cells are used, they must only be requested from the Cord Blood Bank of the CNTS.
The use of any manner or form of progenitor or stem cells of animal origin is strictly forbidden.
ABOUT THE ICMS
The ICMS is a 501(c)(3) nonprofit professional medical organization that is focused on the development of standards for the evaluation of point-of-care, cell-based therapeutics worldwide. With over 3,500 members from over 35 countries, the ICMS is a global leader in patient safety through strict evaluation of therapies and rigorous oversight of clinics and facilities providing cell-based medical therapies. The ICMS maintains an independent Institutional review Board and manages a comprehensive Treatment Registry that tracks patient outcomes. More information can be found at www.cellmedicinesociety.org,