Phase I/II Study of Intravenous Administration of Activated Autologous Adipose-Derived Stromal Vascular Fraction in Patients With Type 2 Diabetes
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Type 2 Diabetes Mellitus
- Sponsor
- Adistem Ltd
- Enrollment
- 34
- Locations
- 2
- Primary Endpoint
- Lowering of blood glucose be it fasting, random or post prandial
- Last Updated
- 17 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Lowering of blood glucose be it fasting, random or post prandial
Time Frame: At 2, 4, 12, 24, 36, and 48 weeks
Secondary Outcomes
- Decrease in anti-hyperglycemic medication dosages.(At 2, 4, 12, 24, 36, and 48 weeks.)
- Improvement in the general well-being of patients.(At 2, 4, 12, 24, 36, and 48 weeks.)
- Lowering of glycosylated hemoglobin (HbA1C).(At 4, 12, 24, 36, and 48 weeks)