SBIR-STTR Award

Approximately 3 million Americans and around 24 million people worldwide are affected by Type 1 Diabetes (T1D). Glucose monitoring followed by exogenous insulin injection, allogeneic whole organ pancreas transplantation, and allogeneic islet transplantation are the most common treatments for T1D. These treatments have achieved glycemic control for many patients but result in serious complications. A bioartificial pancreas is a promising treatment for T1D because it contains functional islets. Unfortunately previous attempts at BAP development have been severely limited by insufficient mass transfer within the islet chamber. The founders of Silicon Kidney have developed silicon nanopore membranes (SNM) to achieve high-efficiency blood ultrafiltration while selectively retaining specific solutes for the Bioartificial Kidney Project and this project's successes are directly transferrable to the iBAP. The ultra-high-hydraulic-permeable characteristic of the SNM will enable appropriate mass transport (especially oxygen, glucose, and insulin) within the islet chamber to achieve optimal islet performance, while the ultra-selective characteristic of the SNM enable unprecedented immunoisolation. The iBAP will be connected between an arterial and venous graft and a pressure drop across the Islet Chamber will produce an ultrafiltrate flow within the Islet Chamber. The ultrafiltrate will provide convective mass transport of nutrients (especially oxygen and glucose) to the Islet Chamber and insulin to the blood channels. The long-term objective of our project is to create the intravascular Bioartificial Pancreas (iBAP) to achieve exogenous insulin independent glycemic control of Type 1 Diabetes (T1D). This Phase I SBIR project will prove the feasibility of the iBAP by demonstrating proper Islet Chamber performance in vitro and iBAP hemocompatibility in vivo.

Public Health Relevance Statement:


Public Health Relevance:
Type 1 Diabetes (T1D) affects over 3 million Americans and incurs a substantial cost on the US health care system. Silicon Kidney is developing a new bioartificial pancreas (iBAP) that will improve T1D outcomes, increase patient quality of life, and significantly reduce the cost of T1D on the health care system.

Project Terms:
Affect; Allogenic; American; Animal Model; Biological Markers; Blood; Blood coagulation; Blood flow; Blood Platelets; Blood Pressure; C-reactive protein; Canis familiaris; Characteristics; clinically relevant; common treatment; cost; cytokine; density; Deposition; Devices; Diffusion; Drops; Exposure to; Glucose; glucose monitor; glycemic control; Haptoglobins; Healthcare Systems; Hemolysis; Hour; Hypertension; Hypotension; Immune; Implant; improved; In Vitro; in vivo; Inflammation; Injection of therapeutic agent; Insulin; Insulin-Dependent Diabetes Mellitus; Interleukin-6; islet; Islets of Langerhans Transplantation; Kidney; Kinetics; lactate dehydrogenase 3; Membrane; Modeling; nanopore; Nutrient; Organ; Outcome; Oxygen; Pancreas; pancreas development; Pancreas Transplantation; Patients; Performance; Permeability; Phase; phase 2 study; Physiological; Polymers; Preclinical Testing; pressure; Production; Proteins; public health relevance; Quality of life; Shapes; Side; Silicon; Small Business Innovation Research Grant; solute; success; Thick; Thrombosis; Thrombus; Ultrafiltration; Variant; Venous

Approximately 3 million Americans and around 24 million people worldwide are affected by Type 1 Diabetes (T1D). Exogenous insulin injection, allogeneic whole organ pancreas transplantation, and allogeneic islet transplantation are the most common treatments for T1D. These treatments can achieve glycemic control for many patients but result in serious complications. A bioartificial pancreas is a promising treatment for T1D because it contains functional islets. However, previous attempts to develop a bioartificial pancreas have been severely limited by insufficient mass transfer within the islet chamber. Silicon Kidney LLC has developed and is commercializing the silicon nanopore membranes (SNM), which achieves high-efficiency blood ultrafiltration while selectively retaining specific solutes. The ultra-high hydraulic permeability characteristic of the SNM will enable appropriate mass transport (especially oxygen, glucose, and insulin) within the islet chamber to achieve optimal islet performance, while the ultra-selective pore characteristic of the SNM enable unprecedented immunoisolation. The ultimate objective of this Phase II SBIR project is to create a full-scale iBAP containing a clinically relevant islet dose and perform pre-clinical hemocompatibility and functionality testing in a large scale animal model.

Public Health Relevance Statement:
Type 1 Diabetes (T1D) affects approximately 3 million Americans and incurs a substantial cost to the US health care system. Our multidisciplinary team at Silicon Kidney LLC and the University of California, San Francisco is developing a new intravascular bioartificial pancreas (iBAP) that will improve T1D outcomes, increase patient quality of life, and significantly reduce the cost of T1D on the health care system.

Project Terms:
Adult; Affect; Allogenic; American; Animal Model; Area; arm; Arteries; base; Beta Cell; biomaterial compatibility; Blood; Blood flow; Blood Pressure; Cadaver; California; Cells; Characteristics; Clinical; Clinical Research; clinical translation; Clinical Trials; clinically relevant; common treatment; Convection; cost; density; design; Devices; Diffusion; Dose; Drops; Encapsulated; Family suidae; fasting glucose; Foundations; Geometry; Glucose; glycemic control; Healthcare Systems; Housing; Human; Implant; implantation; improved; In Vitro; Injections; Insulin; Insulin-Dependent Diabetes Mellitus; intravenous glucose tolerance test; islet; islet stem cells; Islets of Langerhans Transplantation; Kidney; Kinetics; Legal patent; Mechanics; Membrane; Modeling; multidisciplinary; nanopore; Nutrient; Organ; Outcome; Oxygen; Pancreas; Pancreas Transplantation; Patients; Performance; Permeability; Phase; Physiological; Polymers; Positioning Attribute; pre-clinical; Preclinical Testing; Preparation; pressure; Production; prototype; Quality of life; Research; San Francisco; Silicon; Small Business Innovation Research Grant; solute; Source; Technology; Testing; Therapeutic immunosuppression; Tissue Donors; type I diabetic; Ultrafiltration; Universities; Veins