SALT LAKE CITY, Sept. 20, 2019 /PRNewswire/ -- SymbioCellTech, LLC , a biotechnology company in Salt Lake City pioneering stem cell therapy for diabetes and associated auto-immune disorders and microvascular conditions, today announced the online journal PLOS ONE published interim data demonstrating ongoing safety and efficacy of "Neo-Islet" cellular therapy, a technology that co-aggregates mesenchymal stem cells with culture-expanded pancreatic islet cells to form three-dimensional cellular clusters, termed "Neo-Islets." A single dose of Neo-Islets administered into the abdominal cavity provides durable blood sugar control without the need for potentially toxic anti-rejection drugs or encapsulation devices.
Type-1 diabetes is an auto-immune disease in which the patient's own immune system attacks and destroys the islet cells of the pancreas, resulting in an inability for the body to produce insulin. The American Diabetes Association estimates that over 20% of U.S. medical expenditures can be attributed to the provision of diabetes care, and the World Health Organization estimates over 10,000 people die every day from diabetes and its associated complications. The standard cell therapy for Type 1 diabetes is islet cell transplantation into the liver, however, this approach is expensive and has serious drawbacks, including the need for potentially toxic immunosuppressive drugs, and it also suffers from a lack of available donor pancreas cells to treat the large number of patients in need of therapy.
In order to avoid the need for immunosuppressive agents, other biotechnology companies have utilized artificial encapsulation devices made from foreign material, however, scientists at SymbioCellTech have employed adult stem cells to block the immune attack on transplanted pancreatic islet cells, a process they term "natural encapsulation." By using this approach, rather than placing an artificial device in the body, the Neo-Islets do not mount a foreign body reaction that can lead to graft and therapy failure. Neo-Islets are biologically pure cellular structures that possess all functions of normal pancreatic islet cells, while permanently shielding their pancreatic islet cell component from rejection and immune-mediated destruction.
In the PLOS ONE journal article, Interim report on the effective intraperitoneal therapy of insulin-dependent diabetes mellitus in pet dogs using "Neo-Islets," aggregates of adipose stem and pancreatic islet cells (INAD 012-776), SymbioCellTech scientists describe the results of implanted Neo-Islets into pet dogs that had naturally developed auto-immune Type-1 diabetes, which largely resembles human Type I diabetes. Within a few months, all treated dogs experienced a reduction in the need for exogenous insulin without the need for anti-rejection drugs or encapsulation devices. SCT previously showed the Neo-Islets continue to produce all physiological hormones that normal healthy pancreatic islets secrete (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5689775/).
Based on the strength of these preclinical data, SymbioCellTech is preparing for an FDA Investigational New Drug (IND) submission to gain approval to begin testing Neo-Islet therapy in human clinical trials in patients with Type I diabetes.
In conclusion, SymbioCellTech scientists believe that Neo-Islet therapy is a durable all-biologic platform that has the potential to revolutionize the treatment of a Type I Diabetes and other auto-immune diseases. Currently, SymbioCellTech is focused on treating insulin-dependent diabetes due to the magnitude of this global medical problem.
The cited publication can be found here: https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0218688
SymbioCellTech, LLC is a privately held biotechnology company in Salt Lake City, Utah, focused on the development of stem cell therapies for the treatment of diabetes, microvascular, neurodegenerative, and auto-immune diseases. The aforementioned results are from an FDA-approved canine clinical trial testing the safety and efficacy of Neo-Islets as a functional cure for Type-1 diabetes in pet dogs. SymbioCellTech is now preparing an FDA IND submission for human clinical trials for Type-1 diabetes. For more information on SymbioCellTech, please visit www.symbiocelltech.com.