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

Phase I/II Study of Intravenous Administration of Activated Autologous Adipose-Derived Stromal Vascular Fraction in Patients With Type 1 Diabetes

Status

UNKNOWN

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00703599

Enrollment

Registered

2008-06-23

Start date

2007-11-30

Completion date

2009-12-31

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 1 Diabetes Mellitus

Keywords

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

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.

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

16 Years to 60 Years

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.

Design outcomes

Primary

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

Secondary

Measure	Time frame
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.

Countries

Philippines

Contacts

Primary ContactLetitia Lucero-Palma, MD

lettielucero@yahoo.com63-916-478-7512

Outcome results

None listed

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