Stemcelldoc's Weblog

March 27, 2009

Stem Cell Therapy Accountability

Stem cell therapy has become exceedingly popular in the political, clinical, regulatory and patient advocate forums.  Many clinics both here in the United States and aboard have sprung up as a result of this international interst.  Unfortunately there is a significant amount of ambiguity in terms of understanding the basic concepts of stem cell therapy

 There are many different types of stem cells.  For simplicity,  they can be divided into embryonic and adult.  Adult stem cells can be further categorized as being allogenic, meaning that they came from another individual or autologous meaning  that they came for the same patient.   Autologous adult stem cells can be further divided based upon phenotype but the majority of the published research has been with mesenchymal stem cells.  This cell line is associated high levels of ‘repair function’.

Unfortunately patients are often unable to obtain answers to  questions whcih are critical to the success of there therapy:  what type of stem cells am I receiving, how many cells,  were the cells expanded and if so under what conditions?

In an effort to ensure patient safety a new association was been formed:  The American Stem Cell Therapy Association (ASCTA).  The ASCTA is a physician run organization with the mandate to produce a laboratory and clinical guidelines for minimal culture expansion of autologous, adult stem cells (A-ASC’s).  The group is comprised of various medical and surgical specialities whose goal is to to bring safe stem cell therapy to patients.  Please visit:  www.stemcelldoctors.org

 

FDA.FDAregulationof stemcells.FDAregulationoftissue.FDAletteragainstRegenexx.FDAwarninglettertoRegenexx
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