LOS ANGELES--(BUSINESS WIRE)--Advanced Cell Technology, Inc. (OTCBB:ACTC) today announced that it completed discussions with the Food and Drug Administration (FDA) regarding its retinal pigmented epithelial (RPE) cell therapy through a type B, pre-Investigational New Drug (pre-IND) meeting concerning the regulatory pathway and requirements to file an IND to initiate human clinical trials. ACT is working with the agency to fulfill the FDA’s requirements to bring its RPE cell therapy into human clinical trials for the treatment of retinal degenerative diseases such as Retinitis Pigmentosa, Stargardt’s disease, and dry age-related macular degeneration (AMD). The RPE cells are derived from human embryonic stem cells created from ACT single blastomere cell lines under GMP compliant conditions. ACT is moving forward with its characterized RPE manufacturing process to complete the final stages of the company’s preclinical testing. Should ACT successfully file an IND for its RPE therapy, the company plans to move forward with Phase I human clinical trials. ACT’s Myoblast therapy, an autologous adult stem cell therapy for the treatment of heart failure, has already successfully completed Phase I human clinical trials and is moving into Phase II human clinical trials shortly.
