Diabetes T2
Type 1 diabetes results from autoimmune-mediated destruction of insulin-secreting β cells in the islets of Langerhans of the pancreas, whereas Type 2 diabetes is a disease of older individuals that is due to systemic insulin resistance and reduced insulin secretion by pancreatic β cells. Surgical resection of the pancreas may also cause insulin dependent diabetes depending on the size of the remaining pancreas. Somajen D 70 Supraselective infusions focus on improving islet function, insulin resistance, glycemic control, regeneration of pancreatic islet beta cells, increase in endogenous insulin levels and an overall reduction in HbA1c and insulin supplementation.
Protocol
Biologic
Follow-up
Endpoint parameters
Somajen D 70 Supraselective intrapancreatic – dorsal pancreatic artery, gastroduodenal (superior pancreaticoduodenal artery), splenic artery. Aimed at halting / reducing supplemental insulin intake
Somajen D 70 Proprietary biologic / Bone Marrow derived mononuclear cells (autologous trial)
1Y: 30D, 3M, 6M, 12M Baseline diagnostic tests; DSA & CTA, plasma glucose test, hyperglycemia levels, endogenous insulin production;
C-peptide, exogenous insulin intake, tests for recognized genetic mutations; HMGA1, Diabetes Self- Management Questionnaire (DSMQ), follow-up by endocrinologist
Improving islet function, insulin resistance, glycemic control, regeneration of pancreatic islet beta cells; increase in endogenous insulin levels. Reduction in HbA1c and insulin supplementation
Inclusion criteria: Type-2 Diabetes Mellitus (T2DM); M/F (Ag18-70); hyperglycemic; receiving insulin therapy, recognized genetic mutations may disqualify patients
Regeneration
Generation of insulin-producing cells from progenitor cells
Stem cells are instructed to develop into cells with a β-like phenotype by expression of transcription factors known to promote pancreas and islet development and incubation with additional soluble inducers. Genes that allow selection (such as neomycin resistance or green fluorescence protein) are also introduced into the cells under control of the insulin promoter, facilitating purification of cells expressing the insulin gene. The selected cells can be further engineered with immunoprotective genes and encapsulated to increase their survival following transplantation into diabetic patients.
