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https://www.prnewswire.com/news-releases/sanbio-announces-fda-clearance-for-the-initiation-of-a-phase-i2a-clinical-trial-testing-their-cell-therapy-product-sb623-in-patients-with-traumatic-brain-injury-210850531.html

MOUNTAIN VIEW, Calif., June 10, 2013/PRNewswire/ -- SanBio Inc., a California-based regenerative medicine company, announced today that the U.S. Food and Drug Administration has approved their Investigational New Drug application (IND) for the use of SB623, a novel allogeneic stem cell therapy product, in patients suffering from traumatic brain injuries (TBI's). This approval allows the company to proceed with a Phase 1/2a clinical trial testing the safety and feasibility of the therapy. The clinical trial is expected to be carried out at several major hospitals in the United States.

"This is the second clinical program for SanBio," said Keita Mori, SanBio's Chief Executive Officer, "we see this as a clear validation of our development program and a significant broadening of the therapeutic application of our lead product SB623 for the treatment of unaddressed chronic neurological deficits."