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
  Purpose

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.


Condition Intervention Phase
Type 2 Diabetes Mellitus
Procedure: Autologous Adipose-derived Stem cells
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase I/II Study of Intravenous Administration of Activated Autologous Adipose-Derived Stromal Vascular Fraction in Patients With Type 2 Diabetes

Resource links provided by NLM:


Further study details as provided by Adistem Ltd:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 34
Study Start Date: November 2007
Estimated Study Completion Date: January 2009
Estimated Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment Group
This is the only arm and that is the treatment group.
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.

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 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.

  Eligibility

Ages Eligible for Study:   40 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00703612

Locations
Philippines
Beverly Hills Medical Group
Makati City, Manila, Philippines, 1223
Veterens Memorial Medical Centre
Quezon City, Manila, Philippines, 1229
Sponsors and Collaborators
Adistem Ltd
Investigators
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
  More Information

Additional Information:
Publications:
Responsible Party: Bill Paspaliaris / Director, Adistem Ltd
ClinicalTrials.gov Identifier: NCT00703612     History of Changes
Other Study ID Numbers: Adis-002
Study First Received: June 19, 2008
Last Updated: June 28, 2008
Health Authority: Philippines: Department of Health

Keywords provided by Adistem Ltd:
Diabetes Mellitus
Adipose-derived stem cells
Adipose stromal vascular fraction
Autologous
Hyperglycemia

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on April 15, 2014