Humberto Mestre Payne
Last year when I sat in the Aula del Sinodo in the Vatican I really began, for the first time, to comprehend the vast universe of adult stem cells and their tangible therapeutic potential. The conference Regenerative Medicine: A Fundamental Shift in Science and Culture took what I knew about stem cell science and amplified it to a whole new level. As I marveled at concepts ranging from good manufacturing protocols to randomized controlled clinical trials, I realized that I had been imbued with a new level of scientific professionalism and knowledge. I couldn’t wait to use my new excitement to help spread the message about adult stem cell therapies and to Mexico, several issues began to temper my enthusiasm.
First, is Mexico’s internationally recognized, yet infamous reputation as a destination for stem cell therapy medical tourism. In these clinics (most of them in U.S. border cities, i.e. Tijuana) patients from all over the world come to receive autologous stem cell transplants for a steep price. Many of these clinics have filed for clinical trial status and have been listed on the Clinical Trial Registry of U.S. National Institutes of Health–a U.S. federally-funded medical research institute. What troubles me, and should trouble anyone looking for these treatments, is the fact that none of these clinical trials (many of which have been registered since 2011), have ever published any results. There are, however, countless stories of patients receiving stem cell treatments with dismal outcomes, and who demand reimbursement for their squandered investment. These poorly controlled studies steal away potential patients from legitimate, well-structured clinical trials in both the U.S. and Mexico. More importantly, the purity and the safety of the stem cells that these laboratories procure are also questionable. It’s disappointing how the dismal results of these “backroom” clinical procedures obscure the real restorative power of authentic stem cells.
I couldn’t imagine how Mexico could permit these institutions to pursue research ventures without even insisting on minimal compliance to good clinical practices or manufacturing protocols. As I delved deeper into the matter, I realized that Mexico’s legislature is decades behind on regulating stem cell research. Deficient laws cripple the authority of COFEPRIS, the Mexican equivalent of the U.S. FDA. The lack of even basic oversight on stem cell research in Mexico allows these clinics to easily access sanitary licenses, culture adult stem cells and transplant them with no regulation; and they do not require periodic monitorization and safety studies as are required in legitimate clinical trials. There are laws that pertain to hematopoietic progenitor cells and bone marrow transplants, but this leaves a big area of stem cell research open for exploitation.
As a Student Ambassador to the Stem for Life Foundation, I felt compelled to bring this issue to the forefront of discussion. Fortunately, I was not alone; several investigators from the most prestigious research institutions in Mexico are dealing with similar issues. In an attempt to raise awareness I met with the General Director of the National Center for Blood Transfusions in Mexico City, the governmental organization responsible for stem cell legislation. During this meeting, it was clear that the administrators at the National Center were unaware of the damage that these unregulated trials have on Mexican stem cell research and public health.
The National Center is responsible for drafting the norms that dictate the use of cell therapies in Mexico. Unfortunately, these guidelines are about 20 years behind where research stands today. Mexico needs to generate the necessary legislation using functional models like the International Society of Stem Cell Research’s guidelines for the clinical translation of stem cells.
The best way for me to bring this issue to the forefront of discussion was to organize a symposium with the key players in Mexican stem cell research. The symposium was held on March 13, 2014 at Universidad Anáhuac in Mexico City, and you can read more about the symposium in this issue. We convened leading authorities on stem cells in Mexico and leading physicians that have completed accurately designed and executed clinical trials. We stressed the fact that Mexico is several years behind in biotechnology and cellular therapeutics, and highlighted successful models such as the U.S. The participation and excitement for the event was inspiring, and hopefully will incite the necessary change in Mexico’s regulatory system.
As a result of our efforts and together with the Secretary of the General Council of Health– one of our country’s most important advisors on matters of health policy–a working group known as the Committee for Regenerative Medicine and Advanced Cellular Therapeutics has been developed for this precise purpose. This committee will have the daunting task of evaluating the needs of my country in matters pertaining to policy making on stem cell research. I am proud to have been invited to be a part of the Committee’s activities.
All of this was inspired by a week in Rome with the Stem for Life Foundation. I hope that you too will somehow find the inspiration to advance the cause.