New Cell Therapy Product Closer to Reality for Type 1 Diabetics
A new potentially life-changing device for people with Type 1 diabetes mellitus (T1DM) is one step closer to being available for general use on patients. The device, which is the size of a Band-Aid, is made by ViaCyte, Inc. and delivers human progenitor stem cells designed to regenerate pancreatic cells that produce insulin. ViaCyte is headquartered in San Diego, California with additional operations in Athens, Georgia and is funded in part by the California Institute for Regenerative Medicine (CIRM) and the Juvenile Diabetes Research Foundation (JDRF).
According to the company the encapsulation device called the Encaptra® drug delivery system holds pancreatic progenitor cells produced by a proprietary method from human stem cells and is designed to protect the transplanted cells from a patient’s immune system. Encaptra® can be implanted under the patient’s skin during a surgical procedure that can be performed on an outpatient basis. Once implanted the progenitor cells are expected to develop into mature pancreatic cells capable of secreting insulin and other proteins, and regulating blood sugar levels.
This is the first product candidate of its kind geared toward treating diabetes via encapsulated replacement islet cells. This therapy could reduce or even eliminate the need for insulin injections.
In July 2014 ViaCyte, Inc. filed an Investigational New Drug application (IND) with the United States Food and Drug Administration (FDA) seeking to initiate a Phase 1/2 clinical trial. The application was accepted in August 2014 after which STEP ONE testing to evaluate efficacy, tolerability and safety of the VC-01™ Combination Product began at the University of California San Diego Health System with the support of the UC San Diego Sanford Stem Cell Clinical Center. The trial is under the direction of Principal Investigator Robert Henry, MD.
The opening of a second Phase 1/2 trial testing site at the University of Alberta Hospital in Edmonton, Alberta, Canada was announced by ViaCyte, Inc. in July 2015. The lead Edmonton investigator is JDRF CCTN-funded researcher, Dr. James Shapiro, whose laboratory developed the Edmonton Protocol for the transplant of pancreatic islets as a treatment for T1D. He also holds a Canada Research Chair in Transplant Surgery and Regenerative Medicine.
Dr. Shapiro says “This is a remarkable opportunity that could free T1D patients from severe complications and health issues such as hypoglycemia, eye, kidney and cardiovascular diseases, all without the requirement of powerful lifelong immunosuppression drugs.”
The Canadian trial is funded in part by the JDRF Canadian Clinical Trial Network (CCTN). The STEP ONE clinical trials in Edmonton are also being supported by a Collaborative Research and Innovation Opportunities (CRIO) grant from Alberta Innovates – Health Solutions (AIHS).