IND filed for first Clinical Trial using hESCs to treat Dry AMD, Advanced Cell Technology (ACTC.OB)
ACTC.OB has filed an Investigational New Drug (IND) Application with the US FDA to initiate a Phase I/II multicenter study using human embryonic stem cell (hESC) derived retinal pigment epithelial (RPE) cells to treat patients with Dry Age-Related Macular Degeneration (Dry AMD).
- The Phase I/II trial will be a prospective, open-label study that is designed to determine the safety and tolerability of the RPE cells following sub-retinal transplantation to patients with Dry AMD;
- A total of 12 patients will be enrolled in the study at multiple clinical sites;
- The sites which are currently under consideration are the Jules Stein Eye Institute at UCLA; the Ophthalmology Department at Stanford University School of Medicine; and the Edward S. Harness Eye Institute at Columbia University College of Physicians and Surgeons;
- Additional sites may be considered.
“Filing this IND represents the culmination of years of innovation and hard work by ACT’s scientific team,” said William M. Caldwell IV, Chairman and CEO of ACT. “With this second IND, and our plans to expand our studies in Europe, ACT is positioning itself as a true ‘translational’ leader in the field of regenerative medicine. When you are the first, the whole world’s eyes are on you, and in our case, most especially the eyes of the patients that suffer from AMD.”