We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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
March 25, 2008
March 28, 2008
June 16, 2011
January 2008
January 2012   (Final data collection date for primary outcome measure)
  • Exogenous insulin requirement [ Time Frame: 5 ]
  • Hemoglobin A1c [ Time Frame: 5 ]
  • Glucose and C-peptide levels [ Time Frame: 5 ]
Same as current
Complete list of historical versions of study NCT00646724 on ClinicalTrials.gov Archive Site
  • 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 ]
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
Intervention Model: Single Group Assignment
Masking: None (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.
 
Unknown status
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
Sexes Eligible for Study: All
18 Years to 60 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
China
 
 
NCT00646724
fuzhough0712
fuzhough0712
Yes
Not Provided
Not Provided
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