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AlloCure, Stem Cell Therapy for Kidney Failure

AlloCure,  the developer of an adult stem cell therapy for severe kidney disease, has moved its headquarters from Salt Lake City to Burlington, MA and hired a new President and CEO, Robert Brenner, MD. AlloCure is preparing for Phase 2 Trials in Acute Kidney Injury and has reached an important milestone in their evolution, with the completion of enrollment in a Phase 1 trial in acute kidney injury and are now preparing for a Phase 2 study aimed at providing clinical proof-of-concept for our technology.

This study was designed to give patients a single high-dose infusion of these mesenchymal stem cells after they underwent surgery which put them on a heart bypass machine. While patients weren’t randomly assigned to a control group to offer a strong comparative benchmark, researchers did follow other patients who got similar surgeries without the cell therapy infusion.

AlloCure have a different strategy that hinges on an infusion of adult stem cells that might be able to prevent acute kidney injury from happening, or help reverse the damage in the early stages; having learned how to take a certain kind of adult stem cell found in the bone marrow, called mesenchymal stem cells, and greatly expand their numbers in a consistent manufacturing procedure. Importantly, they’ve shown they can isolate cells without certain markers on the surface, known as antigens; that could provoke the patient’s immune system to recognize the cells as foreign invaders that must be attacked. This means that cells from any individual could be grown and infused into any patient, without requiring a genetic match. Because the infusion would be standardized, it’s possible the cells could be kept in stock at hospitals and given “off-the-shelf” when a kidney specialist sees signs of acute kidney injury.

Acute kidney injury (AKI) is a serious medical condition and is associated with considerable morbidity, mortality and healthcare costs. There are currently no effective treatment options to prevent or treat AKI, other than supportive measures, including dialysis. AlloCure’s innovative cell therapy offers the promise of improving outcomes in patients afflicted with this serious condition.

AlloCure was founded in 2008 and previously known as NephroGen, have made great progress in the development of the first effective cell therapy for the treatment of kidney diseases as well as other unmet medical needs. The AlloCure laboratory in Hamburg, Germany, headed by Chief Scientific Officer and Professor Axel Zander, together with Professor Claudia Lange, both prominent stem cell biologists and bone marrow transplant experts, has developed proprietary and highly efficient protocols for the harvesting, expansion, and functional characterization of bone marrow-derived human Mesenchymal Stem Cells (NYSEARCA:MSC), also termed Multipotent Stromal Cells. These AlloCure protocols were used to prepare the allogeneic MSCs (no matching of donor and recipient tissues required, permitting off-the-shelf use) that were tested in the phase I clinical trial for acute kidney injury. The design of the trial was based on extensive pre-clinical studies conducted by Dr. Christof Westenfelder, Chief Medical Officer, an experienced investigator in the field of Nephrology, at AlloCure’s laboratory in Salt Lake City, Utah. This work established the protective activity of MSCs in experimental acute kidney injury, and identified the critical mechanisms whereby these cells both protect and stimulate the repair and return of function of an injured kidney or other organ. Both the Hamburg and Salt Lake City laboratories continue to pursue important investigations in support of the therapeutic application of these unique MSCs.

AlloCure, a privately held, venture-funded company, raised a $14.5M Series A financing from SV Life sciences and Novo A/S in July 2008. AlloCure’s headquarters is now located in Burlington, MA with other locations in Salt Lake City, UT and Hamburg, Germany. For more information about AlloCure: http://www.allocure.com. (HWM and L Timmerman, Xconomy)