Taking an individual’s own stem cells, treating them and injecting them into that person’s eye, wound or tumor, is that a breakthrough medical treatment or quackery?
Well, depending on who’s doing it and what they’re actually doing, it could be either.
at the heart of two events I attended concerning the Food and Drug
Administration’s guidances on human
cell, tissue and cellular and tissue-based products (HCT/Ps).
HCT/Ps are part
of the new area known as regenerative medicine—
replacing, engineering or regenerating human cells, tissues or organs to
restore or establish normal function. The FDA’s regulation of HCT/Ps is tiered and risk-based.
Those that only minimally manipulate cells or tissue, are used in a
function similar to that of the original cells or tissues ,
are not combined with something else and don’t have a negative effect on the
body are not required to go
through FDA premarket review, which is a lengthy process. The FDA has issued four draft HCT/P
guidances it wants to finalize.
There was an
incredible range of people at these meetings: a scientist whom everyone said
should have won the
and maybe still will; people from companies that have been
in business for a long time and now are finding that, depending on how
FDA defines terms in its new guidances, they may suddenly have to
put their products through a regulatory process that could take years; people
from companies that readily accept that their product has to go
through pre market review but object that other companies
are claiming their
products qualify as less risky when, in fact, they pose a harm to
There were horror stories of unqualified people injecting stem cells into patients’ eyes and causing them to go blind.
And there were speakers asking, “Why would FDA regulate use of our own body's tissue?”
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