Advanced Cell Technology, Inc., a leader in the field of regenerative medicine, announced that it is amending the patient treatment protocol for the remainder of the Company’s Phase I clinical trials for Stargardt’s macular dystrophy (SMD) and dry age-related macular degeneration (dry AMD) currently being conducted in the U.S. and will also submit an amendment in Europe for the SMD trial being conducted there. Patients with better vision, a visual acuity of 20/100, will be eligible for enrollment in the remainder of the trials. By treating patients earlier in the course of the disease, the company believes that the amended patient protocol will have a more significant impact on photoreceptor rescue and visual function. In previous protocols, only SMD patients with a visual acuity no better than hand movement in the treated eyes and dry AMD patients with a visual acuity of 20/400 were eligible.
“Having recently reached the halfway point in our three clinical trials for macular degeneration, now is an opportune time to pursue modifications which could help accelerate the pace of all three trials,” says Gary Rabin, chairman and CEO. “The advanced age of many of our enrolled patients has tended to limit the pace at which we are able to enroll and treat them, since other, unrelated health complications tend to come up more frequently in the elderly. Patients with better vision tend to be younger on average.”
The company plans to institute the amended patient protocols upon receipt of Institutional Review Board (IRB) approval from each of the clinical sites, for the second half of all the clinical trials.
“We are pleased to be able to expand patient enrollment in all three of our ongoing clinical trials,” says Robert Lanza, ACT’s chief scientific officer. “Not only does it have the potential to accelerate the road to the completion of Phase I, but having a more diverse patient population could also provide additional clinical insights.”