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
• 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

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes Mellitus

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

External Links

•   NIH website describing basic facts on adult stem cells