Safety and Efficacy of Autologous Adipose-Derived Stem Cell Transplantation in Patients With Type 1 Diabetes

Study Overview
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Brief Summary
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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
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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.

Official Title
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Phase I/II Study of Intravenous Administration of Activated Autologous Adipose-Derived Stromal Vascular Fraction in Patients With Type 1 Diabetes

Conditions
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Type 1 Diabetes Mellitus

Intervention / Treatment
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* Procedure: Autologous Adipose-derived Stem cells


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>This is the only arm and that is the treatment group. | Procedure: Autologous Adipose-derived Stem cells<br>* Intravenous administration of autologous activated stromal vascular fraction derived from 100-120 ml lipoaspirate following mini-liposuction of abdominal adipose tissue.<br>* Other names: Treatment Group;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lowering of insulin-dependence and anti-hyperglycemic medication dosages |  | At 2, 4, 12, 24, 36, and 48 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes Mellitus, Adipose-derived stem cells, Adipose stromal vascular fraction, Autologous, Insulin-dependence