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

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  Active, not recruiting
Sponsor:
Information provided by:
Adistem Ltd
ClinicalTrials.gov Identifier:
NCT00703612
First received: June 19, 2008
Last updated: June 28, 2008
Last verified: June 2008

June 19, 2008
June 28, 2008
November 2007
December 2008   (final data collection date for primary outcome measure)
Lowering of blood glucose be it fasting, random or post prandial [ 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 NCT00703612 on ClinicalTrials.gov Archive Site
  • Decrease in anti-hyperglycemic medication dosages. [ Time Frame: At 2, 4, 12, 24, 36, and 48 weeks. ] [ Designated as safety issue: Yes ]
  • Improvement in the general well-being of patients. [ Time Frame: At 2, 4, 12, 24, 36, and 48 weeks. ] [ Designated as safety issue: Yes ]
  • Lowering of glycosylated hemoglobin (HbA1C). [ Time Frame: At 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 Type 2 Diabetics
Phase I/II Study of Intravenous Administration of Activated Autologous Adipose-Derived Stromal Vascular Fraction in Patients With Type 2 Diabetes

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.

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.

Interventional
Phase 1
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Type 2 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.
Experimental: Treatment Group
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.
 
Active, not recruiting
34
January 2009
December 2008   (final data collection date for primary outcome measure)

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
Both
40 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
Philippines
 
NCT00703612
Adis-002
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
Adistem Ltd
June 2008

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