Trial record 20 of 37 for:    Islets of Langerhans Transplantation | Open Studies

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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by Fuzhou General Hospital.
Recruitment status was  Recruiting
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
  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: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ 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 ]

Secondary Outcome Measures:
  • 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 ]

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

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided

Responsible Party: FUZHOU GENERAL HOSPITAL
ClinicalTrials.gov Identifier: NCT00646724     History of Changes
Other Study ID Numbers: fuzhough0712, fuzhough0712
Study First Received: March 25, 2008
Last Updated: June 15, 2011
Health Authority: China:Fujian Province branch of Food and Drug Administration

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

ClinicalTrials.gov processed this record on August 01, 2014