We are at a cross roads in cellular medicine.  Adult stem cells have become very mature in their animal models of treating a wide variety of diseases including orthopedic, cardiovascular, internal organ disease (such as diabetes), etc…  This morning’s news of the patient’s own adult stem cells treating heart attack in a dose dependant fashion is not surprising. This story of adult stem cells helping with heart repair illustrates this fork in the road well.  Here a big pharma style company is trying to commercialize the patient’s own stem cells through an FDA approval process.  However, these are simple selected CD34+ cells, so this could also be readily done in a physician run stem cell lab.  The difference?  Cost for one.  Tens of millions of dollars will be spent going through this drug process to ultimately manufacture these cells to have a “product shelf life”.  That last part doesn’t make sense, since they are the patient’s own stem cells.  Are the patient’s own adult stem cells a drug?  The FDA has asserted they are, but there are many physicians who would disagree.  These physicians are creating stem cell lab guidelines to allow safe medical practice through the American Stem Cell Therapy Asasociation.  A recent press release codfies their position as being opposed to the FDA.  Patients are also now getting together to oppose this FDA position.

Last summer we got a letter from the FDA stating that they felt that our Regenexx medical procedure was actually the manufacturing of a new drug.  This letter made no sense, as what we’re doing is practicing medicine.  We kindly wrote back stating our position and then we didn’t hear back for more than half a year.  Recently, the FDA has again asserted that they believe we are manufacturing a drug.  They haven’t given any credible rationale for why they believe this, as what we’re doing with adult stem cells is no different than the average fertility clinic that grows embryos in culture for re-implantation.  The fertility clinic is not regulated as a drug manufacture facility.  The fertility specialists fought that fight and won.

ASCTA is a physician organization that was formed in opposition to the FDA’s position that adult stem cells are drugs. This group heralds a much bigger movement than what we’re doing here with the Regenexx-C procedure.  We’ve found literally an outcry by patients with chronic diseases that the FDA would stand in their way of getting safe stem cell work performed by their doctors.  We agree that there are hundreds of likely unsafe stem cell outfits around the globe injecting God knows what into whoever has the will to pay.  All the more reason for an organization to step to the forefront to establish physician run guidelines for safe lab practices and clinical oversight.

I think Don Margolis has a good summary of the issues.

The pre-clinical research on adult stem cells is much stronger than embryonic stem cells.  The research community would agree that your own adult stem cells are likely the least risky of the lot (between embryonic, cord blood, or someone else’s adult stem cells).  When I’ve posed the question to numerous doctors and experts in the field, are your own stem cells drugs?  They look at me like I’m crazy, and often reply, “Of course my stem cells aren’t drugs!”.  Why would the FDA take the position that your cells are drugs?  Like anything, there’s more to the story.  The best business model for stem cells is someone else’s cells (adult or embryonic) in a vial.  These can be manufactured like drugs, crazy things can be done to them like inserting genes to improve their patent-ability, and then sold wholesale into the drug distribution pipeline.

The ASCTA physician group will be getting out it’s lab practices guidelines meant to hold new adult stem cell practices to the highest standards to protect patients.  Our goal is clear and it’s a fight worth fighting…Safe Stem Cells Now!

This blog post refers to the Regenexx-C procedure.