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LIFE DIGEST: FDA OKs first embryonic stem cell trials by: Tom Strode - Jan 26, 2009 - comment
The U.S. Food and Drug Administration (FDA) has granted permission for the first human clinical trials using embryonic stem cells.
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Geron Corp., a California-based biotechnology firm, announced the ground-breaking development Jan. 23, saying it would use the cells from human embryos in experimental treatments of patients with severe spinal cord injuries. Using as many as seven medical centers in the country, Geron plans to inject the stem cells into the location where the spinal cord was injured from 7 to 14 days after the accident in each patient.
Thomas Okarma, Geron’s president, hailed the FDA decision, saying it marked “the beginning of what is potentially a new chapter in medical therapeutics – one that reaches beyond pills to a new level of healing: the restoration of organ and tissue function achieved by the injection of healthy replacement cells.”
Embryonic stem cell research (ESCR), however, is flawed, critics point out, because it requires the destruction of tiny human beings in their first days of life and experiments with laboratory animals have been plagued by problems, including the development of tumors.
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The FDA had placed a hold in May on Geron’s application for clinical trials.
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