Overview

This trial is active, not recruiting.

Condition type 2 diabetes mellitus
Treatment autologous adipose-derived stem cells
Phase phase 1/phase 2
Sponsor Adistem Ltd
Start date November 2007
End date December 2008
Trial size 34 participants
Trial identifier NCT00703612, Adis-002

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
This is the only arm and that is the treatment group.
autologous adipose-derived stem cells
Intravenous administration of autologous activated stromal vascular fraction derived from 100-120 ml lipoaspirate following mini-liposuction of abdominal adipose tissue.

Primary Outcomes

Measure
Lowering of blood glucose be it fasting, random or post prandial
time frame: At 2, 4, 12, 24, 36, and 48 weeks

Secondary Outcomes

Measure
Decrease in anti-hyperglycemic medication dosages.
time frame: At 2, 4, 12, 24, 36, and 48 weeks.
Improvement in the general well-being of patients.
time frame: At 2, 4, 12, 24, 36, and 48 weeks.
Lowering of glycosylated hemoglobin (HbA1C).
time frame: At 4, 12, 24, 36, and 48 weeks

Eligibility Criteria

Male or female participants from 40 years up to 70 years old.

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

Additional Information

Official title Phase I/II Study of Intravenous Administration of Activated Autologous Adipose-Derived Stromal Vascular Fraction in Patients With Type 2 Diabetes
Principal investigator Emeritta A Barrenechea, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in June 2008.
Information provided to ClinicalTrials.gov by Adistem Ltd.