Posts Tagged ‘regenex’

If my own stem cells can repair my back, why are they drugs?

April 18, 2009

It’s been known for sometime that adult stem cells (the type in your body) can repair your low back discs (at least in animals). While surgery will only weaken these discs, stem cells can repair them? A few years ago we undertook research to see if this would work in people. We first tried the type of stem cells that you can get from a bedside centrifuge machine (BMAC), didn’t work.  It likely didn’t work because the number of stem cells you can get in this type of same day procedure is just not enough.  So we then did what they did in the research and started to grow the cells in culture to bigger numbers.  After figuring out the specifics, we had it working inside of a year.  Now the FDA is claiming these stem cells in your body that can be used to fix your back are drugs?    What are your stem cells drugs?  No reason given.  Recently patients have banded together to oppose the FDA on this issue as well.

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Are Adult Stem Cells Drugs?

April 9, 2009

spine-model

Adult stem cells live in all of us.  They come in various types, the most commonly mentioned in therapy being hematopoetic and mesenchymal stem cells.  Mesenchymal stem cells are released by your body in many different types of injury.  If you break a bone or tear ligament, cartilage, or tendon tissue, these cells spring into action as reapir cells.  Your body will even increase the amount locally, say in a knee injury through “culture expansion”, meaning your body grows more when it needs them.  The Regenexx procedure mimics this process by growing more of these mesnechymal stem cells to use in the culture process.  The FDA contends that the Regenexx procedure constitues a drug.  But is this a drug?  Since the function of the tissue is not changed, this type of minimal culture expansion doesn’t create something new.  Does the research show that there are risks to this process?  No the research is clear that limited growing of these cells likely poses no new risks.  So why the argument between the Regenexx procedure and the FDA?  In a phrase, “big pharma”.  The big pharma business plan for adult cells requires that they be classified as drugs, or else the business model is broken.  Physicians and patients have come together to support doctors in using these minimal culture procedures to treat a variety of diseases.  Let the drug companies heavily modify cells as drugs by inserting new genes and reversing adult cells back to embryonic cells, let doctors practice medicine by using the patients own adult stem cells to treat disease.