by Dan Roberts
(Updated February 1, 2008)
Advanced Cell Technology (ACT) in Massachusetts announced on September 23, 2004 that they had engineered human embryonic stem cells which could be used to repair a damaged retina. The research team worked with stem cells taken from human embryos made by another team at Harvard University and coaxed them to form retinal cells, which were clearly defined as resembling rod and cone photoreceptors. The report was published in the September 2004 issue of Cloning and Stem Cells.
In an interview with Reuters news service, Dr. Robert Lanza, scientific director of ACT, said that the report illustrated the need to use cloning technology. In some experiments at that time, eye cell transplants had been rejected by the patient’s immune system; but cells cloned from a person’s own genetic material have been found to be a perfect match.
On February 1, 2008, ACT announced that it completed discussions with the Food and Drug Administration (FDA) regarding its 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. Should ACT successfully file an IND for its therapy, the company plans to move forward with Phase I human clinical trials.
by Dan Roberts