StemCells, a cell-based therapeutics company of Newark, Calif., has enrolled and transplanted stem cells into the first patient in its phase I/II clinical trial in dry age-related macular degeneration (AMD).
The trial is designed to evaluate the safety and preliminary efficacy of the company's proprietary HuCNS-SC product candidate (purified human neural stem cells) as a treatment for dry AMD. The patient received the transplant at the Retina Foundation of the Southwest (RFSW) in Dallas, Texas.
"This trial signifies an exciting extension of our on-going clinical research with neural stem cells from disorders of the brain and spinal cord to now include the eye," said Stephen Huhn, vice president and head of the CNS program at StemCells. "Studies in the relevant animal model demonstrate that the company's neural stem cells preserve vision in animals that would otherwise go blind and support the therapeutic potential of the cells to halt retinal degeneration. Unlike others in the field, we are looking to intervene early in the course of the disease with the goal of preserving visual function before it is lost."
The open-label, dose-escalation study is expected to enroll a total of 16 patients. The HuCNS-SC cells will be administered by a single injection into the space beneath the retina in the most affected eye. Patients' vision will be evaluated using both conventional and advanced state-of-the-art methods of ophthalmological assessment. Evaluations will be performed at predetermined intervals over a one-year period to assess safety and signs of visual benefit. Patients will then be followed for an additional four years in a separate observational study. Patients interested in participating in the clinical trial should contact the site at (214) 363-3911.