Phase I/II Study of Intravenous Administration of Activated Autologous Adipose-Derived Stromal Vascular Fraction in Patients With Type 1 Diabetes
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Type 1 Diabetes Mellitus
- Sponsor
- Adistem Ltd
- Enrollment
- 30
- Locations
- 2
- Primary Endpoint
- Lowering of insulin-dependence and anti-hyperglycemic medication dosages
- Last Updated
- 17 years ago
Overview
Brief Summary
The purpose of this study is to determine whether intravenous administration of autologous adipose stem cells is safe and beneficial in patients with type 1 diabetes.
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 I/II study is to determine whether the intravenous administration of activated adipose-derived stromal vascular fraction as a single procedure is safe and efficacious in patients with Type 1 Diabetes Mellitus. Patients will be observed over 12 months following the procedure, with 2 weeks, 1 month and tri-monthly diagnostics and life style questionaires.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Confirmed diagnosis of Type I diabetes for at least 2 years
- •Insulin-dependent
Exclusion Criteria
- •Presence of acute diabetic complications in the acute stage as recent myocardial infarction, recent CVA or acute renal failure.
Outcomes
Primary Outcomes
Lowering of insulin-dependence and anti-hyperglycemic medication dosages
Time Frame: At 2, 4, 12, 24, 36, and 48 weeks
Secondary Outcomes
- Lowering of glycosylated hemoglobin (HbA1C).(At 4, 12, 24, 36, and 48 weeks)
- Increased circulating C-Peptide levels(At 4, 12, 24, 36, and 48 weeks.)
- Increased general well-being of patients.(At 2, 4, 12, 24, 36, and 48 weeks.)
- No detrimental change seen in kidney function tests, liver function tests and other haematological parameters.(At 2, 4, 12, 24, 36, and 48 weeks.)