Can stem cells fix a knee?

Cartilage is funny stuff.  It’s a shock absorber and filled with cells, so it’s alive.  For a long time, we doctors believed is was so much inert filler so we developed a surgical culture of trimming it and cutting it out.  This was called debridement.  The problem is that arthoscopic surgery for knee pain doesn’t work.  The reason, cutting out living cells turns out to be a bad idea.  So the next step is actually trying to fix cartilage.  We have demonstrated on MRI that using the patient’s own stem cells can help the appearance of knee cartilage (as seen on high resolution MRI) as well as the pain reported by patients.  The secret appears to be taking the patient’s own stem cells and growing them to bigger numbers.  The FDA has taken a strange position on all of this, but doctors and patients have other ideas.  In the meantime, fixing cartilage with stem cells seems like a better idea than cutting it out.

New Physician Group Releases Lab Guidelines for Safe Stem Cell Therapy

The American Stem Cell Therapy Association (ASCTA) announced this week the publication of their lab guidelines.  The group of physicians have come together to oppose the FDA’s position that the patient’s own adult stem cells are drugs.  Why is this important?  The FDA’s believes that classifying adult stem cells as drugs will improve safety.  However, many of the drug manufacturing guidelines don’t apply to the processing of a patient’s own cellular material, a bit like trying a force square peg in a round hole.  ASCTA has put together lab guidelines that will allow for lab safety that is much more specific to adult stem cells.  The first US lab to adopt these new guidelines will be the Regenexx lab in Colorado.  I was privileged to serve on the lab guidelines committee with noted scientists from various medical schools and biotech companies.

Patient Group Opposes FDA Position on Adult Stem Cells

Are your adult stem cells drugs?  The FDA has been sparring with physicians and patients over this issue.  Today a patient group registered it’s opposition to this FDA stem cell position.  For a real dose of reality about how good you have it, check out the “Patient Voices” section of this site.  These are people with terminal illness who are dying.  This whole debate started with the FDA’s position that the minimal stem cell culture process of the Regenexx procedure should be classified as a drug.  Why?  No real specifics give, it seems to be a “cause I said so” issue.  This lead to physicians organizing to regulate themselves so that patients can have access to safe adult stem cell therapy now.  Where is all of this going?  Adult stem cells processed with minimal culture techniques aren’t drugs, I suspect the best quote is from a physician from Ft. Meyers Florida who recently joined The American Stem Cell Therapy Association (ASCTA), “This is a patient physician situation and the FDA needs to stay out.  I commend all of you for starting this.”  Enough siad.