Safety and Efficacy of Autologous Adipose-Derived Stem Cell Transplantation in Type 2 Diabetics

• Decrease in anti-hyperglycemic medication dosages. [ Time Frame: At 2, 4, 12, 24, 36, and 48 weeks. ] [ Designated as safety issue: Yes ]
• Improvement in the general well-being of patients. [ Time Frame: At 2, 4, 12, 24, 36, and 48 weeks. ] [ Designated as safety issue: Yes ]
• Lowering of glycosylated hemoglobin (HbA1C). [ Time Frame: At 4, 12, 24, 36, and 48 weeks ] [ Designated as safety issue: Yes ]

The purpose of this study is to determine whether intravenous administration of autologous adipose-derived stem cells is of benefit in the management of types 2 diabetics.

Diabetes Mellitus is of large epidemic proportions worldwide. It is proliferating at such a fast rate that new novel drugs and other therapeutic approaches are required. The purpose of this Phase 1/Phase 2 study is to determine whether the intavenous administration of activated adipose-derived stromal vascular fraction as a single procedure is safe to and can benefit the disease pathology of patients with Type 2 Diabetes Mellitus (insulin resistance). Patients will be observed over 12 months following the procedure, with a 2 week, 1 month and then tri monthly diagnostics and life style questionaires.

Inclusion Criteria:

• Confirmed diagnosis of Type II diabetes for at least 2 years
• Type 2 diabetics on oral hypoglycemic agents and/or insulin
• Fasting blood sugar of >200mg% on at least two occasions
• Willing to keep a weekly diary and undergo observation for 12 months

Exclusion Criteria:

• Presence of of previous and/or acute diabetic complications such as myocardial infarction, CVA or nephropathy