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Cotransplantation of Islet and Mesenchymal Stem Cell in Type 1 Diabetic Patients

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2011 by Fuzhou General Hospital.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00646724
First Posted: March 28, 2008
Last Update Posted: June 16, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Fuzhou General Hospital
  Purpose
The study evaluates the safety and efficacy of Cotransplantation of Islet and Mesenchymal Stem Cell in Type 1 Diabetic Patients. The researchers hypothesize that additional Mesenchymal Stem Cell infusion can benefit the promising clinical islet transplantation through the following mechanisms: protection of islet from inflammatory damage, immunological modulation, engraftment promotion, thus decrease or eliminate the need of exogenous insulin and improve β-cell function.

Condition Intervention Phase
Type 1 Diabetes Mellitus Biological: cotransplantation of islet and mesenchymal stem cell Phase 1 Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Cotransplantation of Islet and Mesenchymal Stem Cell in Type 1 Diabetic Patients

Resource links provided by NLM:


Further study details as provided by Fuzhou General Hospital:

Primary Outcome Measures:
  • Exogenous insulin requirement [ Time Frame: 5 ]
  • Hemoglobin A1c [ Time Frame: 5 ]
  • Glucose and C-peptide levels [ Time Frame: 5 ]

Secondary Outcome Measures:
  • liver function [ Time Frame: 5 ]
  • kidney function [ Time Frame: 5 ]
  • Portal vein Ultrasound [ Time Frame: 1 ]
  • autoantibodies [ Time Frame: 5 ]
  • Complete Blood Count [ Time Frame: 5 ]

Estimated Enrollment: 30
Study Start Date: January 2008
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
cotransplantation of islet and mesenchymal stem cell
Biological: cotransplantation of islet and mesenchymal stem cell
islet of allograft and MSCs of autograft

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male and female patients age 18 to 60 years of age
  • Ability to provide written informed consent
  • Manifest signs and symptoms that are severe enough to be incapacitating
  • Patients with poor diabetes control (HbA1c > 7% but < 12%)
  • Progressive diabetic complications

Exclusion Criteria:

  • age < 18 years or > 60 years
  • diabetic history < 5 years
  • BMI > 27
  • body weight > 80 kg
  • exogenous insulin requirement > 1 unit/kg/day
  • severe anemia (male < 8 g/dl, female < 7 g/dl)
  • low white blood cell count (< 3000/dl)
  • liver dysfunction
  • Active infection including hepatitis B, hepatitis C, HIV, or TB
  • panel reactive antibody > 20%
  • Any medical condition that, in the opinion of the investigator, will interfere with the safe completion of the trial
  Contacts and Locations
Information from the National Library of Medicine

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): NCT00646724


Contacts
Contact: Jianming Tan, Professor 008613375918000 TANJM156@YAHOO.COM.CN

Locations
China, Fujian
Fuzhou General Hospital Recruiting
Fuzhou, Fujian, China, 350025
Sponsors and Collaborators
Fuzhou General Hospital
Investigators
Principal Investigator: Jianming Tan, professor Fuzhou General Hospital
  More Information

Responsible Party: FUZHOU GENERAL HOSPITAL
ClinicalTrials.gov Identifier: NCT00646724     History of Changes
Other Study ID Numbers: fuzhough0712
First Submitted: March 25, 2008
First Posted: March 28, 2008
Last Update Posted: June 16, 2011
Last Verified: June 2011

Keywords provided by Fuzhou General Hospital:
Islets of Langerhans Transplantation
Mesenchymal Stem Cells
Type 1 Diabetes Mellitus

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