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

Phase 1

• Conditions: Type 1 Diabetes Mellitus
• Interventions: Procedure: Autologous Adipose-derived Stem cells

• Registration Number: NCT00703599
• Lead Sponsor: Adistem Ltd

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.

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: 2009-11
• Study Completion: 2009-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Lowering of insulin-dependence and anti-hyperglycemic medication dosages	At 2, 4, 12, 24, 36, and 48 weeks

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (2)

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

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