SBIR-STTR Award

The overall objective of this research program is to develop implantable microreactors containing islets for treatment of diabetic patients. We will focus on development of technology required to fabricate these microreactors, and on in vitro studies of islet viability and function. These spherical microreactors will consist of a core which contains the islets, surrounded by a permselective shell. This permselective coating permits crossover of low molecular weight substances, including nutrients, electrolytes, oxygen and bioactive secretory products such as insulin, but not of immunocytes and other transplant rejection effector mechanisms. These microreactors are of sufficiently small diameter that they can be injected subcutaneously, intraperitoneally or in other sites simply by using a hypodermic syringe and needle. This approach does not require lifelong regimen of immunosuppressive drugs with serious side effects. In addition, it does not require costly and complicated surgery, and offers a solution to the presently insurmountable problem of procuring sufficient numbers of human pancreatic organs by permitting xenografting of islets from animal sources.Awardee's statement of the potential commercial applications of the research:Development of implantable microreactors would enable transplantation of islets isolated from animals into diabetic patients without use of immunosuppressive drugs.National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

We will develop implantable microreactors containing islets from animal sources for treatment of diabetic patients. These spherical microreactors are permselective to permit penetration of lower molecular weight substances including nutrients, electrolytes, oxygen and bioactive secretory products such as insulin, while excluding immunocytes, antibodies, complement and other transplant rejection effector molecule. These microreactors are of sufficiently small diameter that they can be injected subcutaneously, intraperitoneally or in other sites simply by using a hypodermic syringe and needle. This approach does not require a life long regimen of immunosuppressive drugs with serious side effects. In addition, it does not require costly and complicated surgery, and offers a solution to the presently insurmountable problem of procuring sufficient numbers of human pancreatic organs by permitting xenografting of islets from animal sources.Successful Phase I research focused on development of technology required to fabricate these microreactors and in vitro studies of islet viability and function. The Phase II studies will build upon these findings. Microreactor designs and fabrication techniques will be further refined. The in vivo effects of implanted microreactors containing islets from animal sources on glucose homeostasis in diabetic rats and dogs will be examined in detail. A preferred microreactor design and fabrication protocol will be developed for testing in diabetic patients.National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)