The clinical need for novel technologies that effectively treat patients with T1DM and render them insulin-independent is great. Endogenous insulin replacement by pancreas or islet transplants is currently the only treatment that can achieve insulin-independence and provide significant end organ protection in patients with autoimmune-mediated T1DM. However, the shortage of pancreas donors and the need for repeated islet transplants, requiring up to five donors each, continue to limit the availability of these expensive therapies. Both transplant modalities depend on the permanent use of potentially toxic antirejection drugs. We previously reported that allogeneic, i.p. administered “Neo-Islets” (NIs), composed of cultured islet cells coaggregated with high numbers of immunoprotective and cytoprotective Adipose Derived Stem Cells (ASCs) reestablished normoglycemia in autoimmune T1DM NOD mice without the use of encapsulation devices or immunosuppressive agents. With FDA guidance, we are currently testing this NI technology in a pilot study of insulin-dependent, spontaneously diabetic pet dogs by the i.p. administration of 2x10e5 NIs/kg bw to metabolically controlled (blood glucose, triglycerides) dogs under light anesthesia and ultrasound guidance. Dogs are continued on insulin as needed and are to be followed for 3 years for adverse events, glycemic control, insulin need. Two dogs have been treated. One has been followed for 6 months, the other for 3 months. While decreasingly insulin dependent with significantly improved glycemic control, and no IgG response to the allogeneic NIs, no adverse events have been observed.
In conclusion, these data demonstrate that this novel technology is safe, feasible and holds promise for the treatment of dogs with insulin dependent DM, but that further protocol/dosing optimization is required.
C. Westenfelder: Consultant; Self; SymbioCellTech, LLC. A. Gooch: Other Relationship; Self; SymbioCellTech, LLC. N.K. Loy Son: None. N. Avila: None. J.R. Fischer: None.