StemCells, Inc. Clinical Trial Treats Additional Dry AMD Patients
StemCells, Inc., a California-based developer of stem-cell therapies, has begun treating the second group of participants with advanced dry age-related macular degeneration (AMD) in its 16-person, Phase I/II clinical trial for its human neural stem-cell therapy.
Launched in 2012, the study is primarily assessing the safety of the treatment, which researchers believe may release therapeutic proteins to keep the retina healthy and slow vision loss. Study investigators will also evaluate changes in vision and retinal anatomy.
The first group of eight patients entered the trial with best corrected visual acuity (BCVA) no better than 20/400 in their most-affected eye. Four patients in the group received doses of 200,000 cells. The other four received doses of one million cells.
The second group of eight patients enrolled with BCVA between 20/320 and 20/100 in their most-affected eye and is receiving doses of one million human-neural stem cells.
Stephen Huhn, M.D., vice president, CNS Clinical Research at StemCells, Inc., says the company hopes to release interim study results in June of 2014 and initiate a proof-of-concept Phase II clinical trial in 2015. The Phase II study would further evaluate efficacy of the therapy and compare it with a placebo.
The Phase I/II clinical trial is taking place at five centers in the United States. More information on the study is available at the clinical trials website hosted by the National Institutes of Health.
Ray Lund, Ph.D., a stem-cell scientist previously funded by the Foundation Fighting Blindness, conducted laboratory research that made this clinical trial possible.