ACT Receives Approval from Data and Safety Monitoring Board (DSMB) to Treat Next Patients in Stem Cell Clinical Trials
Last update: 9/28/2011 8:30:09 AM
Pioneering Stem Cell Studies for Treating Macular Degeneration Advance to Next Step
MARLBOROUGH, Mass., Sep 28, 2011 (BUSINESS WIRE) -- Advanced Cell Technology, Inc. ("ACT"; OTCBB: ACTC), a leader in the field of regenerative medicine, announced today that the independent Data and Safety Monitoring Board (DSMB) overseeing the Company's two ongoing stem cell clinical trials in the United States authorized ACT to move forward with enrolling and treating the next set of patients in each of the trials. In July, surgeons led by Steven Schwartz, M.D., Ahmanson Professor of Ophthalmology at the David Geffen School of Medicine at UCLA and retina division chief at UCLA's Jules Stein Eye Institute treated the first patients in the Company's clinical trials for Stargardt's Macular Dystrophy (SMD) and Dry Age-Related Macular Degeneration (Dry AMD) using retinal pigment epithelial (RPE) cells derived from human embryonic stem cells (hESCs). Each patient received an injection of 50,000 hESC-derived RPE cells in one of their eyes. Both the Dry AMD and SMD clinical trials are dose-escalation studies involving twelve patients in each, and are designed to evaluate the safety and tolerability of the injected RPE cells. The study design involves four cohorts of three patients each being treated at a predetermined dose of RPE cells, ranging from 50,000 to 200,000 cells. Based on the results of the first patient in each study, the DSMB authorized the Company to move forward with the next two patients in the studies. Each of these additional patients will also be treated with 50,000 RPE cells.
"The unanimous recommendation of the DSMB to proceed with the next four patients represents a significant milestone for our clinical programs. We hope that the positive trend in clinical results derived from treating the first patients with our RPE cells will continue," said Robert Lanza, M.D., chief scientific officer of ACT. "The DSMB approval is an important step towards confirming the safety of our cells. We hope that the treatment of the next patients will provide further evidence that our stem cell-derived RPE cells are a safe and effective treatment option for patients with a range of macular degenerative diseases such as Dry AMD and SMD."
