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

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ClinicalTrials.gov Identifier: NCT00703612
Recruitment Status : Unknown
Verified June 2008 by Adistem Ltd.
Recruitment status was:  Active, not recruiting
First Posted : June 23, 2008
Last Update Posted : July 1, 2008
Sponsor:
Information provided by:
Adistem Ltd

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Procedure: Autologous Adipose-derived Stem cells Phase 1 Phase 2

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : November 2007
Estimated Primary Completion Date : December 2008
Estimated Study Completion Date : January 2009

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Arms and Interventions
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Arm Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  1. Lowering of blood glucose be it fasting, random or post prandial [ Time Frame: At 2, 4, 12, 24, 36, and 48 weeks ]

Secondary Outcome Measures :
  1. Decrease in anti-hyperglycemic medication dosages. [ Time Frame: At 2, 4, 12, 24, 36, and 48 weeks. ]
  2. Improvement in the general well-being of patients. [ Time Frame: At 2, 4, 12, 24, 36, and 48 weeks. ]
  3. Lowering of glycosylated hemoglobin (HbA1C). [ Time Frame: At 4, 12, 24, 36, and 48 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   40 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00703612


Locations
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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
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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
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Publications:

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Responsible Party: Bill Paspaliaris / Director, Adistem Ltd
ClinicalTrials.gov Identifier: NCT00703612    
Other Study ID Numbers: Adis-002
First Posted: June 23, 2008    Key Record Dates
Last Update Posted: July 1, 2008
Last Verified: June 2008
Keywords provided by Adistem Ltd:
Diabetes Mellitus
Adipose-derived stem cells
Adipose stromal vascular fraction
Autologous
Hyperglycemia
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases