The design of the proposed clinical trial, Phase I/IIa Dose Escalation Safety and Efficacy Study of Human Embryonic Stem Cell-Derived Retinal Pigment Epithelium Cells Transplanted Subretinally in Patients with Advanced Dry-Form Age-Related Macular Degeneration with Geographic Atrophy, is based on a pre-IND meeting with the FDA and a series of earlier interactions with the agency. Patients will undergo a single transplantation and the study will explore three different doses of OpRegen. Following transplantation, the patients will be followed over 12 months at specified intervals and then at longer time periods, to evaluate the safety and tolerability of the product. A secondary objective of the clinical trial will be to explore the ability of transplanted OpRegen to engraft, survive, and moderate the disease progression. The filing of this IND is the culmination of 12 years of research and development starting at the Hadassah Human Embryonic Stem Cell Research Center at Hadassah University Medical Center, Jerusalem, Israel, under the direction of Prof. Benjamin Reubinoff, MD, PhD and continuing at Cell Cure Neurosciences Ltd., said Charles S. Irving Ph.D., Cell Cures CEO. We look forward to initiating the clinical trial that will, for the first time, utilize xeno-free grade human embryonic stem cell … Continue reading →

Targeting gene expression, researchers have developed a method for extracting a wide variety of potential bone-producing cells from human fat. Within our fat live a variety of cells which have the potential to become bones. The adipose tissue, in theory, is a readily available reservoir for regenerative therapies such as bone healing if doctors can get enough of those cells and compel them to produce bone. The method produced over twice the yield of potential bone-makers (nine percent) compared to their best application of another method: sorting cells based on surface proteins presumed to indicate that a cell is a stem cell (four percent), the researchers noted. "Approaches like this allow us to isolate all the cells that are capable of doing what we want, whether they fit the archetype of what a stem cell is or not," said lead author Hetal Marble from Brown University in the US. The scientists developed a fluorescent tag that could find and identify cells expressing a gene called ALPL. Expression of the gene is an indicator of bone-making potential. If the tag hits the target, it glows. A machine that detects the fluorescing light then separates out the ALPL-expressing cells. The ALPL-expressing cells … Continue reading →