In the United States, a stem cell is regulated as a pharmaceutical. Think about that. Living human tissue, reviewed on the same criteria as a synthetic chemical.
At the moment Mexico was set to follow in America’s footsteps, our Medical Director Dr. Tagle was Regional Director of COFEPRIS, Mexico’s FDA equivalent. He took the risk of presenting the alternative case: that a stem cell is closer to a kidney than to a chemical. It is tissue, taken from one person and given to another, and should be treated that way in law. The pharmaceutical industry opposed him. He won.
Mexico became the first country to write a legal framework for therapeutic stem cell use. Governments drafting their own regulations still consult him today. The laboratories now running in Panama and Colombia first learned their protocols in our lab.
That laboratory has run continuously since 2008. It is where our cells are made. Every batch is culture-expanded from ethically sourced donor tissue and screened by flow cytometry before release, at a viability floor of 98%.
SOMA was built on the foundations of that laboratory. We exist to make these therapies available to the patients and families who need them.