The USFDA has approved the investigator investigational new drug (IND) application of University of California, Los Angeles (UCLA), the clinical partner of Advanced Cell Technology (ACT), to commence a clinical trial using the human embryonic stem cells (hESCs)-derived cells to treat severe myopia.
Embryonic stem cell-based trial was designed to assess the hESC-derived ACT’s retinal pigment epithelial (RPE) cells in patients with severe myopia (nearsightedness).
ACT chairman and CEO Gary Rabin said, "We are pleased to be on track to broaden the scope of our RPE program with the initiation of the new Investigator IND."
Around 12 patients are expected to be enrolled with cohorts of three patients in an ascending dosage design in the myopia trial.
The primary endpoint of the prospective, open-label study is to assess the safety and tolerability profile of hESC-derived RPE cells subsequent to sub-retinal transplantation into myopia patients at 12 months.
ACT chief scientific officer Robert Lanza said, "Myopia is one of the most common medical ailments in the world and myopic patients have a higher risk of permanent vision loss due to complications such as fissures in the RPE layer of the eye."