Advance Cell Technology (ACT) just announced that it has received approval from the FDA to commence Phase I/II stem cell clinical trials on patients with severe myopia (nearsightedness). The main purpose of the trials is to evaluate the safety of ACT's product, containing retinal pigment epithelial (RPE) cells, derived from human embryonic stem cells.
The trials will be led by Steven Schwartz, professor of Ophthalmology at the David Geffen School of Medicine at the University of California, Los Angeles (UCLA). The trials will follow a protocol similar to the company's other clinical studies, with a total of 12 patients expected to enrol. Three of them will act as the control group (given placebo treatment), whereas the rest will be divided into three groups, each given a different dosage of RPE cells. The patients will be followed for a total of 12 months.
|Comparison of myopic vision (left) and normal vision (right)|
In a previous press release about a year ago, ACT had announced positive preclinical results for two patients that had received the RPE treatment. During the 4 month follow up period, no adverse effects or cancer activity was reported and both patients exhibited significant improvements in their vision.
Myopia, commonly known as nearsightedness or shortsightedness (British English), is a condition of the eye in which the light that comes in does not directly focus on the retina but in front of it. As a result, the perceived image of a distant object is out of focus. In simple words, the patients finds it difficult to see things that are far away.
Informational video on Myopia
You can read the official press release here