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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on September 16, 2014