StemCells, Inc.’s Therapy for Dry AMD Moves into Phase II Clinical Trial
An emerging stem-cell therapy for slowing the progression of dry age-related macular degeneration (AMD) has moved into a 63-participant, Phase II clinical trial. StemCells, Inc., the developer of the treatment, reports that the first patient has received the transplanted human neural stem cells at the Retina Foundation of the Southwest (RFSW) in Dallas, Texas. The 12-month study is taking place at several additional sites within the United States.
In the earlier, Phase I/II clinical trial, patients with the advanced form of dry AMD known as geographic atrophy demonstrated stable or improved vision at six and 12 months after receiving the treatment. Also, the rate of progression of the disease — the loss of photoreceptors and supportive cells known as retinal pigment epithelium — was reduced in treated eyes versus untreated eyes.
“These neural stem cells produce a variety of neuroprotective agents,” says David Birch, PhD., principal investigator, RFSW. “It is our hope that they will help preserve sick cells in the vicinity of geographic atrophy.”
Based on prior research, scientists believe that human neural stem cells provide sustained release of proteins that keep the retina healthy and prevent or slow degeneration. Ray Lund, Ph.D., a stem-cell scientist previously funded by the Foundation Fighting Blindness, conducted laboratory research that made this clinical trial possible.
“We are pleased to see this clinical trial move forward, thanks to the encouraging, early results,” says Stephen Rose, Ph.D., chief research officer at the Foundation. “Dry AMD affects nearly 30 million people around the world, yet we have no therapies for the condition. It is a significant unmet need.”