With an aging population, obesity on the rise, and sedentary lifestyles becoming increasingly common, diabetes has grown into a major health concern in the U.S. and worldwide. According to the Center for Disease Control (CDC), 29.1 million people or 9.3% of the U.S. population has diabetes, including an estimated 8.1 million who are undiagnosed. According to the American Diabetes Association, the 2012 cost of this disease in the U.S. was “$245 billion per annum or approximately $500,000 every minute.”
In a historic achievement, the Diabetes Research Institute a Center of Excellence at the University of Miami Miller School of Medicine, announced the first patient in its clinical trial had stopped insulin injections after the implantation of islet cells within a biological scaffold.
Given the growing promise of regenerative medicine, the following companies are also exploring cell-based treatments for diabetes.
Companies Developing Cell Therapies for Diabetes
Given the growing promise of regenerative medicine, the following companies are exploring cell-based approaches to reversing diabetes.
In February 2016, San Diego based ViaCyte acquired an exclusive license to “BetaLogics intellectual property in the field of metabolic disease, including diabetes, and the transfer of related assets to ViaCyte.” The news positioned ViaCyte as a leader in stem cell therapeutics for the treatment of Type 1 and 2 diabetes.
According the Dr. Paul Laikind, ViaCyte’s President and CEO, “For more than a decade BetaLogics and ViaCyte have been independently working toward a stem cell-derived therapy for diabetes. By combining the intellectual property and other assets of BetaLogics with ViaCyte, we will further strengthen our advanced program focused on insulin-dependent diabetes and solidify our leadership in the field.”
According to ViaCyte, it differentiates stem cells into pancreatic beta cell precursors (PEC-01™) and subcutaneously implants them into patients using a retrievable medical device (an Encaptra® cell delivery system), allowing the implanted precursor cells to mature into endocrine cells that can secrete insulin and other hormones in a controlled manner to support healthy blood glucose levels.
In September 2015, Sernova Corporation secured exclusive worldwide rights to patent-pending technologies developed by researchers at the University Health Network (UHN) in Canada, with the license giving them the capacity to turn stem cells into glucose-responsive therapeutic cells for use in the treatment of insulin-dependent diabetes.
According to Sernova’s CEO, “This agreement provides us with a proprietary source of stem cell derived glucose responsive therapeutic cells. When placed within Sernova’s prevascularized Cell Pouch(TM), and protected locally from immune system attack, we believe that Sernova has the potential to provide a significant break-through in the quality of treatment for the millions of people suffering from insulin-dependent diabetes.”
In January 2016, Sernova then announced a service agreement with the Centre for Commercialization of Regenerative Medicine (CCRM) to “establish, optimize and validate Sernova’s licensed technology for creating stem cell derived therapeutic cells that produce insulin and are glucose responsive.”
3. Betalin Therapeutics
Betalin Therapeutics, Ltd., based in Ramat Gan, Israel, is led by Mr. Jacob Ben-Arie (CEO). The company is developing the Engineered Micro Pancreas (EMP), a breakthrough technology that will enable it to implant pancreatic cells, which include insulin-producing cells to restore the body’s intrinsic insulin generation capabilities. This miniature pancreas is implanted in the patients’ body under the skin, using a local anesthesia with minimal risk to the patient and costs of the procedure.
Betalin has acquired technology that is based on the premise that in order for beta cells to function properly it is necessary to provide an appropriate stromal (connective tissue) micro-environment. In its first phase, Betalin will use the platform technology to create engineered micro pancreata (EMPs) composed of naked islets (Io) and micro-scaffolds. EMPs will be used instead of naked islets in islet transplantation therapy to provide significant levels of glucose-regulated insulin secretion over extended periods of time.
A small but powerful company working in this area is AltuCell, a company whose mission is to find a cure for insulin-dependent diabetes. Led by CEO Gary Harlem, AltuCell is a private pharmaceutical company with a world-renowned medical team spread across the U.S. and Europe. In a recent peer-review article published in the journal Xenotransplantation on Sept. 27th 2016, AltuCell’s medical lead Dr. Giovanni Luca announced:
“In this study the Calafiore group has transplanted microencapsulated porcine Sertoli cells into the subcutaneous fat of 30 type 2 diabetic-prone obese mice (db/db) after they had become frankly diabetic. Remarkably 60% of the treated mice (18 out of the 30) had their glucose control restored and demonstrated normal glucose tolerance tests. The remaining 40% “failures” all showed improvements as assessed by reduced HbA1c levels. Control mice remained diabetic.”
AltuCell’s preclinical breakthrough utilizing microencapsulated Sertoli cells to establish reversal of diabetes in a murine (mouse) mode is further highlighted in the article “Altucell Releases Evidence in Support of Microencapsulated Sertoli Cells for Reversal of Diabetes.”
5. NextCell Pharma AB
In July 2017, Stockholm based NextCell Pharma submitted an application to the Medical Products Agency for a clinical trial in autoimmune diabetes with its stem cell product ProTrans™. Protrans™ is composed of stem cells derived from the umbilical cord tissue and intended for use in the treatment of inflammatory and autoimmune diseases.
More recently, NextCell Pharma AB announced on September 5, 2017 that its clinical trial application for ProTrans™ had been granted by the Ethics Committee. The clinical trial is designed to evaluate the safety of ProTrans™, as well as its ability to positively affect endogenous insulin production in adult Type 1 Diabetes patients.
6. Osiris Therapeutics
Osiris Therapeutics is exploring the use of its Prochymal cell therapy for multiple indications, including the treatment of diabetes. In 2014, Osiris completed a Phase II Type 1 Diabetes clinical trial that evaluated the efficacy and safety of Prochymal. Titled “PROCHYMAL® (Human Adult Stem Cells) for the Treatment of Recently Diagnosed Type 1 Diabetes Mellitus (T1DM),” the clinical trial was completed December 2014. Prochymal is an adult human mesenchymal stem cell (MSC) product that may delay the progression of type 1 diabetes by preserving beta cell function, and therefore, insulin production.
Mesoblast Limited is exploring the use of its human mesenchymal progenitor cells (MPC) product for the treatment of Type 2 Diabetes. It first demonstrated the efficacy of its product in preclinical trials, as an injection of MPCs into diabetic mice produced an increase in blood insulin levels and a reduction in blood glucose levels.
Mesoblast then moved into clinical trials, publishing the results of its Phase 2 trial of its intravenously (IV) administered MPCs for the treatment of type 2 diabetes in Diabetes Care, a journal of the American Diabetes Association (ADA). Titled “Allogeneic Mesenchymal Precursor Cells in Type 2 Diabetes: A Randomized, Placebo-Controlled, Dose Escalation Safety and Tolerability Pilot Study,” it was the first controlled trial to investigate cell therapy using adult allogeneic mesenchymal lineage cells in subjects with type 2 diabetes. Furthermore, it demonstrated the safety and feasibility of leveraging MPCs in subjects with type 2 diabetes.
Other Companies Exploring Cell Therapies for Diabetes?
Are there other companies that should be on this list? Mention them in the comments below and we’ll add them.