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Research and Development Outlook for the 2018 Calendar Year
Our research and development program for 2018 includes the following:
- Initiate a clinical trial of our Cell Pouch\u2122 in collaboration with JDRF under our recently cleared US IND for patients with hypoglycemia unawareness using human donor islets and a standard of care antirejection drug regimen to further study the safety and efficacy of the device and islets;
- Clinical evaluation of the Cell Pouch\u2122 for insulin-dependent diabetes who have received an islet transplant;
- In coordination with the EU Horizon 2020 HemAcure Consortium. conduct cell production and preclinical studies for treatment of hemophilia A consisting of factor VIII releasing therapeutic cells transplanted within Sernova’s Cell Pouch\u2122;
- Conduct preclinical studies for treatment of hypo-thyroid disease consisting of thyroid hormone releasing tissue transplanted within Sernova’s Cell Pouch\u2122;
- Production of human stem-cell-derived cells for diabetes and in vivo proof of principle assessment of these differentiated human stem cells for their safety and efficacy within Sernova’s Cell Pouch\u2122 for the treatment of insulin-dependent diabetes;
- Assessment of novel microencapsulation technologies within the Cell Pouch\u2122 cells, to further develop and advance Sernova’s therapeutic vision for diabetes of a product consisting of locally immune protected therapeutic cells within the Cell Pouch\u2122; and
- Continue to collaborate with pharmaceutical companies to assess safety and efficacy of our combined technologies in preclinical studies for potential negotiation of a licensing arrangement and commercial development partnership for our hemophilia and diabetes programs.
Quelle: letzter Quartalsbericht