Technology Overview
Adult bone marrow or fat-derived Mesenchymal Stem Cells from unrelated donors are ex vivo aggreghated with cultured Insulin producing Cells from the Pancreas. The resulting 3-D Organoids, "NEo-Islets", are administered, under Ultrasound guidance, into the abdominal cavity of subjects with Type I Diabetes . They are taken up by the Omentum where they engraft and physiologically release Insulin into the portal venous system of the Liver, thereby permanently establishing insulin-independence and normal blood glucose levels. No toxic anti-rejection drugs are required, and ~ 600 therapeutic doses can be produced from a single donor. This highly competitive technology has been tested in mouse modelsof Type I diabetes and shown to be effective in an ongoing FDA-guided clinical pilot study in spontaneously diabetic pet dogs. A successful Pre-IND meeting was held and the required laboratory work that will lead to the issue of an IND for the conduct of a first in human Clinical Trial is underway and needs adequate funding at this time.
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