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Richard Jaffe, Esq.- The Regulation of Stem Cells

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In the last year or two, the regulation of stem cells has dramatically changed. My take on it is that the FDA got tired of the wild west stem cell clinics which had proliferated in the mid to late 2000’s. I take some of the credit/blame for it as I was one of the first attorneys (if not the first to clear doctors to use fat cells for autologous use for arguably homologous use. Here is some background:

From a regulatory point of view, there are two types of stem cells: embryonic and adult.  There is not much to say about the regulation of the clinical use of embryonic stem cells because embryonic stem cells are not in clinical use.  So long as President Bush continues to bar the development of new embryonic stem cell lines, it is unlikely that such cells will be in clinical use anytime soon.

Adult stem cells come in two basic flavors: cells obtained from living, breathing humans, and stem cells obtained from umbilical cords or placental materials.  Stem cells are either autologous, meaning that they come from the same individual, or allogenic, meaning that they come from a different individual.

Another important concept is whether the use of the cells is for a homologous use or purpose, which is a use of the stem cells for the same type or purpose as the origin of that particular stem cell. Thus, a homologous use for a stem cell obtained from the bone marrow would be for a blood or hematological condition.  A nonhomologous use would be for any other use or purpose.  Using umbilical cord blood stem cells to treat a disease such as multiple sclerosis or ALS would be a nonhomologous use.

 

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