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
Information provided by:
Adistem Ltd Identifier:
First received: June 19, 2008
Last updated: June 28, 2008
Last verified: June 2008
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.

Condition Intervention Phase
Type 1 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 1 Diabetes

Resource links provided by NLM:

Further study details as provided by Adistem Ltd:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 30
Study Start Date: November 2007
Estimated Study Completion Date: December 2009
Estimated Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
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.
Other Name: Treatment Group

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 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.

Ages Eligible for Study:   16 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT00703599

Contact: Letitia Lucero-Palma, MD 63-916-478-7512

Beverly Hills Medical Group Recruiting
Makati City, Manila, Philippines
Contact: Florencio Q Lucero, MD    63-917-896-6411   
Principal Investigator: Florencio Q Lucero, MD         
Veterens Memorial Medical Centre Recruiting
Quezon City, Manila, Philippines, 1229
Contact: Emerita A Barrenechea, MD    63-917-811-1008   
Principal Investigator: Emerita A Barrenechea, MD         
Sponsors and Collaborators
Adistem Ltd
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
  More Information

Additional Information:
Responsible Party: Bill Paspaliaris / Director, Adistem Ltd Identifier: NCT00703599     History of Changes
Other Study ID Numbers: Ad-003 
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

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Autoimmune Diseases
Endocrine System Diseases
Glucose Metabolism Disorders
Immune System Diseases
Metabolic Diseases processed this record on May 25, 2016