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

Phase I/II Study of Intravenous Administration of Activated Autologous Adipose-Derived Stromal Vascular Fraction in Patients With Type 2 Diabetes

Status

UNKNOWN

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00703612

Enrollment

Registered

2008-06-23

Start date

2007-11-30

Completion date

2009-01-31

Last updated

2008-07-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes Mellitus

Keywords

Diabetes Mellitus, Adipose-derived stem cells, Adipose stromal vascular fraction, Autologous, Hyperglycemia

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.

Interventions

PROCEDUREAutologous 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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

40 Years to 70 Years

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	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

Countries

Philippines

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026