ACT Eye Trials Begin Dosing Third Patient

Advanced Cell Technology, Inc. (ACT) has announced it is dosing its third patient in a clinical study which utilizes retinal pigment epithelial (RPE) cells taken from human embryonic stem cells (hESCs) to find a treatment for dry age-related macular degeneration (AMD).

The study, currently in its Phase I/II trial stage, began on Jan. 20 of this year, and is projected to last 12 months. ACT is currently conducting clinical trials to determine the effectiveness and safety of sub-retinal injection of hESC-derived RPE cells to treat dry AMD or Stargardt’s macular dystrophy. Each trial consists of 12 patients, divided into groups of three patients each in an ascending dosage format.

“The completion of enrollment of the first cohort of patients in our dry AMD clinical trial is a significant step forward in our RPE clinical program. The first six patients in the U.S. trials have all been treated at UCLA, and as we have recently announced, the trials should soon expand to additional sites,” said Gary Rabin, CEO and chairman of ACT.

“As we have built our clinical team, we have been fortunate to have attracted the attention of some of the highest-caliber ophthalmologists and related institutions in the U.S. and Europe and recognize the huge value that their expertise provides us as we plan for the future of our therapeutic programs. With their guidance, we have also worked with the FDA to successfully expand the criteria of eligibility for patients to participate in our dry AMD trial.”

According to Steven Schwartz, M.D., one of the leading researchers in the UCLA trials, the procedures have been carried out with no complications. There is hope for further progress, considering the tolerance of the patients and the straightforwardness of the operation, says Schwartz.

The trials are being carried out at UCLA’s Jules Stein Eye Institute, the Bascom Palmer Eye Institute in Miami, and the Wills Eye Institute in Philadelphia. A fourth location, the Moorfields Eye Hospital, is located in London, England.

“We still have many patients left to treat during the course of these trials, but our team remains hopeful that stem cell-derived RPE cells may someday provide a new therapeutic approach for the treatment of many forms of macular degeneration,” said Robert Lanza, M.D., chief scientific officer at ACT.

“We hear from patients who suffer from these diseases on nearly a daily basis, and appreciate the huge responsibility we have to them.”





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