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NCT00703599 Clinical Trial

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

Type 1 Diabetes Mellitus Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT00703599
Other study ID # Ad-003
Secondary ID
Status Recruiting
Phase Phase 1/Phase 2
First received June 19, 2008
Last updated June 28, 2008
Start date November 2007
Est. completion date December 2009

Study information
Verified date June 2008
Source Adistem Ltd
Contact Letitia Lucero-Palma, MD
Phone 63-916-478-7512
Email lettielucero@yahoo.com
Is FDA regulated No
Health authority Philippines: Department of Health
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 30
Est. completion date December 2009
Est. primary completion date November 2009
Accepts healthy volunteers No
Gender Both
Age group 16 Years to 60 Years
Eligibility 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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Procedure:
• 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.

Locations
Country Name City State
Philippines Beverly Hills Medical Group Makati City Manila
Philippines Veterens Memorial Medical Centre Quezon City Manila

Sponsors (1)
Lead Sponsor Collaborator
Adistem Ltd

Country where clinical trial is conducted

Philippines, 

References & Publications (1)

Gimble JM, Katz AJ, Bunnell BA. Adipose-derived stem cells for regenerative medicine. Circ Res. 2007 May 11;100(9):1249-60. Review. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Lowering of insulin-dependence and anti-hyperglycemic medication dosages At 2, 4, 12, 24, 36, and 48 weeks Yes
Secondary Lowering of glycosylated hemoglobin (HbA1C). At 4, 12, 24, 36, and 48 weeks Yes
Secondary Increased circulating C-Peptide levels At 4, 12, 24, 36, and 48 weeks. No
Secondary Increased general well-being of patients. At 2, 4, 12, 24, 36, and 48 weeks. Yes
Secondary No detrimental change seen in kidney function tests, liver function tests and other haematological parameters. At 2, 4, 12, 24, 36, and 48 weeks. Yes
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