Advanced Cell Technology, Inc. ("ACT"; OTCBB:ACTC) announced today that it has submitted documentation and a complete response to substantively address the issues raised by the US Food and Drug Administration (FDA) in connection with the Company's plans to initiate a Phase I/II multicenter study using embryonic stem (ES) cell derived retinal cells to treat patients with Stargardt's Macular Dystrophy (SMD). In November 2009, ACT filed an Investigational New Drug (IND) Application to commence treating patients. ACT believes the design of its product and the choice of SMD, from a safety standpoint, represents an ideal cellular product to gain early experience and knowledge about ES cell safety.
“Our batch release assay has a level of detection of less than 0.0001% for ES cell contamination of RPE cell cultures”
The additional details submitted to the FDA support the Company's belief that the product would be safe and well tolerated by patients. The Company's process for differentiating ES cells to retinal pigmented epithelial (RPE) cells is not permissive to ES cell persistence in the culture. In fact, no stem cells could be detected even when the RPE cells were spiked during culture with up to 10 percent ES cells. "Our batch release assay has a level of detection of less than 0.0001% for ES cell contamination of RPE cell cultures," said Robert Lanza, M.D., Chief Scientific Officer at ACT. "We can detect a single stem cell in over a million RPE cells. This is especially significant considering the small number of cells (50,000 to 200,000) to be administered into a controlled space in the eye. Stem cells can't persist in our culture process, and therefore do not pose a risk of contamination of the final RPE cells to be transplanted."