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Print Edition StoriesFriday, April 23, 2010
ACT stem cell study for retina disease returns positive results
By Mass High Tech staff
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Advanced Cell Technology Inc., a regenerative medicine firm in Worcester, has results from an animal study associated with its Phase 1 study for a stem cell-derived treatment of Stargardt’s Macular Dystrophy (SMD).
The company submitted the treatment, which uses Retinal Pigment Epithelium (RPE) cells from embryonic stem cells, to the U.S. Food and Drug Administration in November under an Investigational New Drug Application.
According to ACT (OTC:ACT), the animal studies returned positive results that showed no signs of tumors, ectopic tissues or other safety issues, following the FDA’s requests for further safety data. ACT conducted the studies with Sinclair Research Center LLC, Charles River Laboratories, MPI and Althea Laboratories.
The positive results from the animal study could be enough to prompt the FDA’s clearance for a human study of its AMD treatment, ACT noted in a press release. The company noted that when the Phase 1 trial does begin, it will test safety and tolerability of the RPE cells when transplanted in SMD patients. The ACT study will happen at three clinical sites, including the Casey Eye Institute in Portland, Ore., under Dr. Peter Francis; the UMDNJ – New Jersey Medical School in Newark, N.J., under Dr. Marco Zarbin; and Worcester-based University of Massachusetts Memorial Medical Center, under Dr. Shalesh Kaushal.
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