I have spoken to many different academic researchers working with industry on the use of stem cells for degenerative joint conditions. They tell me that there is no interest in embryonic cells. Any embroyonic implantation introduces another person's DNA with unknown long term risks and ramifications. An embroyonic product would be essentially a drug with all the crushing FDA drug regulations, with additional
embryonic regulation and risk.
Actual development is directed towards harvesting the patient's own blood marrow, processing blood marrow in the operating room to extract the patient's own stem cells. These cells will be injected into the target joint. This all will take place in one procedure within the confines of the O.R.
Any clinical material either entering or leaving the O.R., triggers massive regulatory requirements. A device entering the O.R. that rearranges the patient's own cells is to the FDA only a device, which incurs a mere fraction of the regulatory burden.
posted on 11/11/2006 11:10:32 AM PST
To: 2ndMostConservativeBrdMember; afraidfortherepublic; Alas; al_c; american colleen; annalex; ...
posted on 11/12/2006 12:59:21 PM PST
(Roe v. Wade and Endangered Species Act both passed in 1973, Murder Babies/save trees, geese, algae)
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