Stemcells, Inc. Announces First High-Dose Patient Transplanted in Phase I/II Clinical Trial in Dry Age-Related Macular Degeneration FDA Authorizes Expansion to Five Trial Sites in the United States
NEWARK, Calif., Sep 12, 2013 StemCells, Inc. today announced dosing of the first high-dose patient in the Company’s Phase I/II clinical trial in dry age-related macular degeneration (AMD). The patient, the fifth overall in the 16-patient trial, was transplanted yesterday with one million HuCNS-SC(R) cells (purified human neural stem cells). The first four patients each received a dose of 200,000 cells. An independent Data Safety Monitoring Committee conducted a review of the trial data to date, and found no safety issues to preclude the trial from proceeding to the high dose.
“Advancing to the high dose, which is a five-fold increase from the low dose, is an important milestone in this trial,” said Stephen Huhn, MD, FACS, FAAP, Vice President, CNS Clinical Research at StemCells. “Testing a cell dose of this magnitude in all the remaining patients planned for the trial will enhance our ability to assess the effect of the cells on visual acuity.
“Also, we are pleased to announce that we have received permission from the FDA to open three more U.S. trial sites in addition to the Retina Foundation of the Southwest and the Byers Eye Institute at Stanford, the two currently active centers. Expanding the number of sites will provide easier access to the trial for patients and help us achieve our goal of completing enrollment within the next nine months.”
AMD afflicts approximately 30 million people worldwide and is the leading cause of vision loss in people over 55 years of age. Approximately 90 percent of AMD patients have the dry form of the disease, for which there are no approved treatments