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
Sponsor:
Information provided by:
Adistem Ltd
ClinicalTrials.gov Identifier:
NCT00703599
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 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.

  Eligibility

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

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00703599

Contacts
Contact: Letitia Lucero-Palma, MD 63-916-478-7512 lettielucero@yahoo.com

Locations
Philippines
Beverly Hills Medical Group Recruiting
Makati City, Manila, Philippines
Contact: Florencio Q Lucero, MD    63-917-896-6411    dr-flucero@pldtdsl.net   
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    emieab@yahoo.com   
Principal Investigator: Emerita A Barrenechea, MD         
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, Hong Kong
  More Information

Additional Information:
Publications:
Responsible Party: Bill Paspaliaris / Director, Adistem Ltd
ClinicalTrials.gov 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
Autologous
Insulin-dependence

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on April 23, 2014