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

This study is currently recruiting participants.
Verified June 2011 by Fuzhou General Hospital
Sponsor:
Information provided by:
Fuzhou General Hospital
ClinicalTrials.gov Identifier:
NCT00646724
First received: March 25, 2008
Last updated: June 15, 2011
Last verified: June 2011
History of Changes

March 25, 2008
June 15, 2011
January 2008
January 2012   (final data collection date for primary outcome measure)
  • Exogenous insulin requirement [ Time Frame: 5 ] [ Designated as safety issue: No ]
  • Hemoglobin A1c [ Time Frame: 5 ] [ Designated as safety issue: No ]
  • Glucose and C-peptide levels [ Time Frame: 5 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00646724 on ClinicalTrials.gov Archive Site
  • liver function [ Time Frame: 5 ] [ Designated as safety issue: Yes ]
  • kidney function [ Time Frame: 5 ] [ Designated as safety issue: Yes ]
  • Portal vein Ultrasound [ Time Frame: 1 ] [ Designated as safety issue: Yes ]
  • autoantibodies [ Time Frame: 5 ] [ Designated as safety issue: No ]
  • Complete Blood Count [ Time Frame: 5 ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Cotransplantation of Islet and Mesenchymal Stem Cell in Type 1 Diabetic Patients
Cotransplantation of Islet and Mesenchymal Stem Cell in Type 1 Diabetic Patients

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.
Not Provided
Interventional
Phase 1
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Type 1 Diabetes Mellitus
Biological: cotransplantation of islet and mesenchymal stem cell
islet of allograft and MSCs of autograft
Experimental: 1
cotransplantation of islet and mesenchymal stem cell
Intervention: Biological: cotransplantation of islet and mesenchymal stem cell
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
30
January 2014
January 2012   (final data collection date for primary outcome measure)

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
Both
18 Years to 60 Years
No
Contact: Jianming Tan, Professor 008613375918000 TANJM156@YAHOO.COM.CN
China
 
NCT00646724
fuzhough0712, fuzhough0712
Yes
FUZHOU GENERAL HOSPITAL
Fuzhou General Hospital
Not Provided
Principal Investigator: Jianming Tan, professor Fuzhou General Hospital
Fuzhou General Hospital
June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP