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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2008 by Adistem Ltd.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Adistem Ltd
ClinicalTrials.gov Identifier:
NCT00703599
First received: June 19, 2008
Last updated: June 28, 2008
Last verified: June 2008

June 19, 2008
June 28, 2008
November 2007
November 2009   (final data collection date for primary outcome measure)
Lowering of insulin-dependence and anti-hyperglycemic medication dosages [ Time Frame: At 2, 4, 12, 24, 36, and 48 weeks ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00703599 on ClinicalTrials.gov Archive Site
  • Lowering of glycosylated hemoglobin (HbA1C). [ Time Frame: At 4, 12, 24, 36, and 48 weeks ] [ Designated as safety issue: Yes ]
  • Increased circulating C-Peptide levels [ Time Frame: At 4, 12, 24, 36, and 48 weeks. ] [ Designated as safety issue: No ]
  • Increased general well-being of patients. [ Time Frame: At 2, 4, 12, 24, 36, and 48 weeks. ] [ Designated as safety issue: Yes ]
  • No detrimental change seen in kidney function tests, liver function tests and other haematological parameters. [ Time Frame: At 2, 4, 12, 24, 36, and 48 weeks. ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
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

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.

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.

Interventional
Phase 1
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Type 1 Diabetes Mellitus
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.
Other Name: Treatment Group
Experimental: 1
This is the only arm and that is the treatment group.
Intervention: Procedure: Autologous Adipose-derived Stem cells
Gimble JM, Katz AJ, Bunnell BA. Adipose-derived stem cells for regenerative medicine. Circ Res. 2007 May 11;100(9):1249-60. Review.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
30
December 2009
November 2009   (final data collection date for primary outcome measure)

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.
Both
16 Years to 60 Years
No
Contact: Letitia Lucero-Palma, MD 63-916-478-7512 lettielucero@yahoo.com
Philippines
 
NCT00703599
Ad-003
No
Bill Paspaliaris / Director, Adistem Ltd
Adistem Ltd
Not Provided
Principal Investigator: Emeritta A Barrenechea, MD Veterens Memorial Medical Centre, Philippines
Principal Investigator: Florencio Q Lucero, MD University of Philippines, College of Medicine
Study Director: Letitia Lucero-Palma, MD Far Eastern University-NRMF Hospital, Quezon City, Philippines
Study Chair: Bill Paspaliaris, PhD Adistem Ltd, Hong Kong
Adistem Ltd
June 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP