Stem Cell Trial For Crohn's Disease

Two years ago, I pointed to a therapy for Crohn's disease as a good example of progress in stem cell research. Two years on, companies like Osiris Therapeutics are still navigating the oppressive FDA regulatory maze in order to bring a demonstrated treatment to market. "Osiris Therapeutics, Inc. announced today that it has received clearance from the U.S. Food and Drug Administration (FDA) to begin enrollment in a Phase II clinical trial to evaluate the safety and effectiveness of [an] intravenous formulation of mesenchymal stem cells [obtained] from the bone marrow of volunteer donors between 18-32 years of age." There is a good reason why responsible, commercial stem cell therapies are presently only taking place outside the US, and that something is a three-letter abbreviation for the worst aspects of government interference in medicine and freedom of research.



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