Allogeneic Mesenchymal Stem Cell-Based Treatment Legislation in Latin America: The Need for Standardization in a Medical Tourism Context.

Medicinal signaling cells (MSCs) secrete bioactive molecules with paracrine effects. These cells are widely used in basic and clinical research to treat several human diseases and medically relevant conditions. Although there are promising results, only a few treatments are approved of its administration, and clinicians should not underestimate the potential risks of its application without proper authorization. However, some treatments advertised mainly through the internet are not supported by solid or rigorous scientific evidence, legal consent, or the assurance of safety and efficacy, especially in the cell therapy tourism space. This practice allows patients to travel from stringently regulated countries to less restricted ones and increase the flourishing of nonendorsed therapies in these regions. Clinical applications of MSC-based treatments are subject to health legislation, and regulatory agencies are responsible for supervising their manufacture, quality control, and marketing approval. Consensus is needed to homologize and strengthen health legislation regarding those therapies, particularly in regions where medical tourism is frequent. Latin America and the Caribbean, an overlooked region with very heterogeneous legislation regarding cell therapy, is a popular medical tourism destination. Brazil and Argentina created regulations to supervise cell-based treatment manufacture, quality, and marketing, while Mexico, considered the second-largest drug market in Latin America, does not recognize nor authorize any cell as therapy. Also, some regulatory bodies miss the importance of several critical good manufacture practice processes to ensure reproducible, reliable, safe, and potentially more favorable results and do not consider them in their legislation. These inconsistencies make the region vulnerable to unproven or unethical treatments, potentially becoming a public health problem involving people from countries worldwide. This review attempts to generate awareness for the legal status of cell therapies in Latin America and the need for standardization as this region is a significant medical tourism destination.