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

Adistem

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Type 1 Diabetes Mellitus

Treatments: Procedure: Autologous Adipose-derived Stem cells

Study type: Interventional

Funder types: Industry

Identifiers

NCT00703599

Ad-003

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 16 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

1

Experimental group

Description:

This is the only arm and that is the treatment group.

Treatment:

Procedure: Autologous Adipose-derived Stem cells