Embryonic Stem Cell Research Heads for FDA Approval

Two companies are about to become the first Embryonic Stem Cell biotech firms to draft FDA applications for human testing. For some time, ESC-research opponents have complained that all human trials have involved therapies utilizing adult stem cells, but none have utilized embryonic stem cells. They forget to mention that scientists have been doing research on adult stem cells—mostly from bone marrow—for about 40 years, whereas researchers first isolated human ESCs in 1998. Additionally, the ability of bone marrow-derived stem cells to contribute to the growth of other tissues has not proven consistent.

Nevertheless, this marks a huge step towards one day developing real cures for diseases like diabetes, Alzheimer’s, and Parkinson’s. According to CNNMoney, this first step concerns a treatment for vision loss diseases being carried out by Advanced Cell Technology. According to Chief Scientific Officer, Robert Lanza, the testing could last a minimum of five years followed by the review of an experimental drug which could last a minimum of six months.

The Geron Corporation has also submitted applications for human testing and plans to develop a treatment for spinal cord injuries that has been successful in rats. Both companies plan to begin the actual testing as soon as next year.

Novocell Inc., a privately-held biotech firm, is developing a treatment for diabetes using ESC, but has not completed studies in mice and are still a few years away from human testing.

Currently, the only stem-cell-based product the FDA has approved is Osteocel, a therapy for repairing bone defects by stimulating growth that is classified as a an implant. Osiris Theraputics produces the treatment.

The San Francisco Gate recently covered biotech startup StemLifeLine Inc., located in San Carlos, California. The company plans to acquire left over embryos from from couples who would like to personally benefit from their own stem cells.

The problems with this enterprise are numerous: First, there is no guarantee that stem cell therapies will arise for the specific diseases for which the donors or their family members might eventually need treatment. Stanford bioethicist David Magnus also comments that stem cell therapy might not be around for 30 to 40 years and that the stem cells saved today might not be usable then due to certain technical protocols which might develop in the interim. Moreover, the stem cells, although genetically related to the donors and their families, would not be identical and could still be rejected if transplanted. Nevertheless, Susan Fisher, an advisory-board member of StemLifeLine and director of UC San Francisco’s stem cell program, maintains that the tissues created from these stem cells would still require less anti-rejection drugs than other transplanted tissues.

There is also the ethically thorny issue of couples creating embryos solely to save them for themselves and their families, as opposed to using leftover embryos that were created while trying to conceive a child. As R. Alta Charo (a Science Progress advisory board member) pointed out in the SF Gate article, the ethical approach to this practice “depends on your view of the moral status of the embryo.”

Tags: bioethics, biotech, stem cells

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