Cell Cure initiated a clinical trial for Age-Related Macular Degeneration (AMD) in February at the Hadassah Medical Center, directed by Prof. Benjamin Reubinoff, Chief Scientific Officer of Cell Cure and Director of Hadassah’s Human Embryonic Stem Cell Research Center and Prof. Eyal Banin, head of the Center for Retinal and Macular Degeneration, who were instrumental in the treatment’s development.  The product, called OpRegen®, is a retinal pigment epithelial (RPE) cell formulation derived from human embryonic stem cells (hESCs), characterized by high purity and potency.

To further develop its world-first animal-product free stem cell treatment for AMD, Israel’s Cell Cure Neurosciences Ltd. has received a 6.24 million shekel (approximately $1.6 million dollar) grant from Israel’s Office of the Chief Scientist (OCS).

Prof. Benjamin Reubinoff and Prof. Eyal Banin
Prof. Benjamin Reubinoff and Prof. Eyal Banin

“We thank the Israel Office of the Chief Scientist for its commitment to innovation and for continuing support of Cell Cure and its development of a cell therapy-based treatment for a major disease of aging,” said Charles Irving, PhD, Chief Executive Officer of Cell Cure.

“I join with Dr. Irving in thanking the OCS for its generous support in advancing pluripotent stem cell research into clinical applications,” Prof. Reubinoff related.

The Phase I/IIa study of OpRegen® has been designed to provide preliminary, objective, functional and structural data on this cell transplantation’s ability to slow the progression of geographic atrophy (dry-AMD), in addition to safety data. Dry-AMD severely impacts the quality of life of the elderly and there is as yet no approved therapy.

The clinical trial, involving four groups of patients, will evaluate three different dose regimens. Cell Cure expects to report interim data from the cohorts in the coming months. Details of the trial are available at https://clinicaltrials.gov/ct2/show/NCT02286089?term=OpRegen&rank=1

Dry AMD is the leading cause of visual impairment and blindness among the elderly in the US and other developed countries. While treatment options exist for the treatment of the wet form of AMD, 90 percent of all patients with AMD have the dry form. As Cell Cure’s website explains: “The root cause of dry-AMD is believed to be the dysfunction of RPE cells. Therefore, one of the most exciting new therapeutic strategies for dry-AMD is the transplantation of healthy young RPE cells to support and replace those lost with age. Pluripotent stem cells, such as hESCs, can potentially provide a means of manufacturing such healthy RPE cells on an industrial scale.”

 

 

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