SCT has developed stem cell-based therapies to cure Insulin-Dependent Diabetes, and to treat Microvascular Disorders.
Address: 615 Arapeen Dr. Suite 210
SLC, UT 84108
Phone: 801-979-2823
URL: http://symbiocelltech.com
THE PROBLEM: Type 1 diabetes mellitus (T1DM, juvenile onset) is an autoimmune disorder that results in the destruction of the insulin producing beta cells in the islets of the pancreas. Despite treatment with insulin, multi-organ complications develop, and premature death occurs. Therapies that reestablish insulin production, eliminating the need for insulin injections, and thus halting complications are urgently needed. This is currently done via pancreas or islet transplants, but transplants require life-long anti-rejection drugs that are often toxic, and they require donors. For islet transplants, up to 15 deceased donors are required for one successful transplant. KEY TECHNOLOGY: SCT has developed a durable, stem cell-enabled, biologic therapy for Diabetes in humans and companion animals. Culture expanded pancreatic islet cells are aggregated with high numbers of healthy, adult Mesenchymal Stem Cells (MSCs) to form NEO-ISLETS (NIs) the size of normal islets. When implanted, these NIs begin producing insulin and other islet hormones, supplying the recipient with insulin that is delivered only as needed, improving blood glucose levels, and reducing or eliminating the need for exogenous insulin. SUPERIORITY of SCT’S TECHNOLOGY: Delivered in a simple, minimally invasive out-patient procedure that requires no foreign materials. Pre-clinical testing in mice, and testing in spontaneously diabetic pet dogs show it to be, thus far, free from significant adverse effects. Capable of halting the negative lifestyle impact of diabetes. Scalable for world-wide distribution. Overcomes the donor scarcity issue, as more than 100 therapeutic doses can be generated from one donor (islet transplants require up to 5 donors repeatedly). Overcomes the need for potentially toxic antirejection drugs. Costs: pancreas and islet transplants in patients currently cost ~$300,000. NI therapy is expected to cost ~$100,000.
While SCT is working on multiple aspects of regenerative medicine for microvascular diseases, our current main focus is Type 1 Diabetes, and this section covers only that technology. SCT has developed and is patenting (3 PATENTS) the technology for a fundamentally new, adult stem cell-enabled therapy in which culture expanded pancreatic islet cells are aggregated with high numbers of healthy, adult Mesenchymal Stem Cells (MSCs) to form “Neo-Islets” (NIs) the size of normal islets. The Purpose for engineering NIs of this composition is based on the well-known facts (a) that MSCs can effectively support the survival of neighboring cells, such as islet cells in the NIs, and (b) that they exert powerful anti-inflammatory, cell-survival, angiogenic and, very critically, unique immune modulating actions. The latter, as we show both pre-clinically and in the clinical, real-world FDA guided INAD study being conducted in pet dogs, eliminate the need for the use of potentially toxic anti-rejection drugs or immune-isolating islet cell encapsulation devices that can fail due to foreign body reactions. PUBLICATIONS: Much of SCT’s work is peer reviewed and published in respected scientific journals. SCT’s Preclinical Data are published here: Westenfelder, et al., Stem Cells Transl Med. 2017;6(7):1631-1643. This was the most commonly downloaded and read publication of 2017-2018. Interim results from SCT’s Clinical Data from insulin-dependent, spontaneously diabetic, pet dogs are published here: Gooch, et al., PlosOne 2019; Sep 19;14(9):e0218688. • Based on thus-far positive results from this study, SCT has reached an agreement on Option and Licensing terms for this product with a global French veterinary pharmaceutical company. Similarly, SCT has recently held a successful PRE-IND MEETING with the FDA to pursue the conduct of a phase 1 human clinical trial. A DETAILED SUMMARY of SCT’s supporting studies and illustration of SCT’s main technology is found in the following section.