Stem Cell Therapy Holds New Promise for Type 1 Diabetics
A new stem cell therapy for Type 1 diabetes has received the “green light” from the FDA and Health Canada, signaling the start of clinical trials to assess the safety and efficacy of the technique. The therapy is being developed by ViaCyte, a California-based company focused on regenerative medicine, and it focuses on implanting healthy, functioning pancreatic cells – islet cells – grown from stem cells. The clinical trial will be the first ever to evaluate stem cell-derived islet cells to treat Type 1 diabetes.
ViaCyte’s Novel Approach
In Type 1 diabetes, insulin-producing islet cells in the pancreas are destroyed by the immune system, which means patients are unable to produce the insulin they need to manage their glucose levels. For years, insulin injections were the only method for managing blood sugar levels and preventing potentially life-threatening hypoglycemic episodes. Then more recently, surgeons began transplanting islet cells from donors, enabling Type 1 patients who received the transplants to produce at least some insulin endogenously. While islet cell transplants offered great promise, the approach has been severely limited by the number of islet donors.
ViaCyte’s technique, called PEC-Direct 1, uses stem cells to grow new insulin-producing islet cells, and then transplants those cells into the pancreas of patients with Type 1 diabetes. Because the autoimmune disorder that destroys pancreas cells is still active in Type 1 patients, immune-suppressing medications will be need to be administered on an ongoing basis to prevent the new cells from being destroyed. A second type of therapy also in the works – PEC-Encap – uses a special encapsulated cell delivery system to protect the cells from the immune system reaction.
In the initial trial, 40 patients with Type 1 diabetes will be enrolled. The trial will evaluate how well the stem cell transplant islet cells promote “clinically relevant insulin production” in patients with little to no ability to produce insulin endogenously, the company said. The researchers also will examine the use of injectable insulin during the study as well as the incidence of hypoglycemic events.
Clinical Trials at the Foot & Ankle Clinic
Clinical trials play a critically important role in helping patients with both Type 1 and Type 2 diabetes manage their disease and the complications it can cause. Dr. Felix Sigal is a top clinical researcher in diabetic foot ulcers, helping patients gain access to novel therapies that can make a significant difference in their health and their quality of life. To find out more about the Foot & Ankle Clinic or to learn about the podiatric care and treatment options for people with diabetes, visit us online or call us at 213-365-0793 today.