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

Phase 1

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Procedure: Autologous Adipose-derived Stem cells

• Registration Number: NCT00703612
• Lead Sponsor: Adistem Ltd

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.

Study Timeline

• Study Start: 2007-11
• Status Verified: 2008-06
• Study First Submitted: 2008-06-19
• Study First Submitted QC: 2008-06-20
• Study First Posted: 2008-06-23
• Last Update Submitted: 2008-06-28
• Last Update Posted: 2008-07-01
• Primary Completion: 2008-12
• Study Completion: 2009-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 34

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment Group	Autologous Adipose-derived Stem cells	This is the only arm and that is the treatment group.

Primary Outcome Measures

Name	Time	Method
Lowering of blood glucose be it fasting, random or post prandial	At 2, 4, 12, 24, 36, and 48 weeks

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

Veterens Memorial Medical Centre; 🇵🇭 Quezon City, Manila, Philippines

Beverly Hills Medical Group; 🇵🇭 Makati City, Manila, Philippines