30 Day Trial

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Product / Company Performance

DiscGenics' IDCT Passes Initial Safety Review in Phase I/II Trial -

DiscGenics' injectable disc cell therapy passed an initial planned safety review of its Phase I/II trial for the treatment of mild to moderate degenerative disc disease. An independent data safety monitoring committee recommended no changes to the trial protocol after review of the first six subjects, who were randomly assigned to receive IDCT, vehicle or placebo. The first patient in this U.S.-based trial received treatment in early 2Q18. IDCT is an allogeneic cell therapy comprising Discogenic Cells and a viscous scaffold. During treatment, a dose of IDCT is injected percutaneously into the disc. The prospective, randomized, double-blinded, vehicle- and placebo-controlled 10-center trial will enroll 60 subjects, evaluating safety and preliminary efficacy of IDCT at varying dosage levels. An additional trial in Japan is slated to commence enrollment in 1H19. (DiscGenics, 1/7/19)