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

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-derived stem cells is of benefit in the management of types 2 diabetics.

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 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.

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 2 Diabetes

Conditions
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Type 2 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 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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 70 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: Treatment Group<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>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lowering of blood glucose be it fasting, random or post prandial |  | At 2, 4, 12, 24, 36, and 48 weeks | 

Secondary Outcome Measures

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

 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, Hyperglycemia