StemCells, Inc. Increases Dosing in Dry AMD Clinical Trial
StemCells, Inc. , which launched a Phase I/II clinical trial for its dry age-related macular degeneration (AMD) therapy in October 2012, has begun administering the highest dose of its treatment to patients in the study. The fifth patient in the trial has received a transplant of one million of the company’s human neural stem cells known as HuCNS-SC ® . The first four patients in the study each received transplants of 200,000 cells.
Also, the U.S. Food and Drug Administration (FDA) recently authorized StemCells, Inc. to expand its human study from two to five sites in the United States. The 16-patient study is currently underway at the Retina Foundation of the Southwest (RFSW) in Dallas, Texas, and the Byers Eye Institute at Stanford University in Palo Alto, California. The trial in Dallas is being led by David Birch, Ph.D., chief scientific and executive officer of the RFSW and co-director of the Foundation’s Southwest Regional Research Center for the Study of Retinal Degenerative Diseases. Announcement of the three additional trial sites is forthcoming.
The primary goal of the study is to evaluate the treatment’s safety, though study investigators are also assessing changes in vision and retinal structure. StemCells, Inc. has not reported any study results as of yet. The study’s Data Safety Monitoring Committee, an independent group of experts who monitor patient safety and treatment efficacy for clinical trials , conducted a review of the trial and found no safety issues to preclude treatment of patients with the higher dose.
The HuCNS-SC therapy is designed to integrate into the patient’s retina and release proteins that keep his or her existing retinal cells healthy and functional.
AMD affects 10 million people in the United States and 30 million worldwide. Approximately 90 percent of people with AMD have the dry form. There are currently no FDA-approved treatments for dry AMD.