LOS ANGELES--(BUSINESS WIRE)--Advanced Cell Technology, Inc. (OTCBB:ACTC) and the Casey Eye Institute at Oregon Health & Science University initiated a significant collaboration over a year ago that has culminated in a robust study of dosage and efficacy of the GMP-compliant RPE cells. Today at Neuroscience 2007, these researchers are presenting the results of the study using ACT’s embryonic stem cell derived RPE cells in the RCS Rat, a well validated animal model of retinal disease. The RPE cells were manufactured under GMP compliant conditions (21CFR211) at the company’s facility in Worcester, MA. The RPE cells have been thoroughly characterized and cryo-preserved by the company and were shipped to researchers at OHSU for transplantation. The transplanted rats were given a range of doses of the RPE cells and monitored and evaluated at multiple time points. The results of the study showed that the RPE cells demonstrated a statistically significant therapeutic effect compared to controls with a maximum efficacious effect at a medium dose level. Histological assessment showed integration of the human RPE cells into the rodent’s RPE layer without migration into the retina. The conclusions drawn by researchers were that visual function can be rescued and preserved in this animal model of disease utilizing GMP-compliant human ES-derived RPE cells with a functional dose threshold and that these cells may provide an effective donor cell source to rescue photoreceptors in conditions like Age-related macular degeneration (AMD), where RPE function is compromised. Advanced Cell Technology plans to present this data to the FDA when it files an IND for the RPE therapy.
