Cotransplantation of Islet and Mesenchymal Stem Cell in Type 1 Diabetic Patients
Primary Purpose
Type 1 Diabetes Mellitus
Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
cotransplantation of islet and mesenchymal stem cell
Sponsored by
About this trial
This is an interventional treatment trial for Type 1 Diabetes Mellitus focused on measuring Islets of Langerhans Transplantation, Mesenchymal Stem Cells, Type 1 Diabetes Mellitus
Eligibility 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
Sites / Locations
- Fuzhou General HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
cotransplantation of islet and mesenchymal stem cell
Outcomes
Primary Outcome Measures
Exogenous insulin requirement
Hemoglobin A1c
Glucose and C-peptide levels
Secondary Outcome Measures
liver function
kidney function
Portal vein Ultrasound
autoantibodies
Complete Blood Count
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00646724
Brief Title
Cotransplantation of Islet and Mesenchymal Stem Cell in Type 1 Diabetic Patients
Official Title
Cotransplantation of Islet and Mesenchymal Stem Cell in Type 1 Diabetic Patients
Study Type
Interventional
2. Study Status
Record Verification Date
June 2011
Overall Recruitment Status
Unknown status
Study Start Date
January 2008 (undefined)
Primary Completion Date
January 2012 (Anticipated)
Study Completion Date
January 2014 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Fuzhou General Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes Mellitus
Keywords
Islets of Langerhans Transplantation, Mesenchymal Stem Cells, Type 1 Diabetes Mellitus
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
cotransplantation of islet and mesenchymal stem cell
Intervention Type
Biological
Intervention Name(s)
cotransplantation of islet and mesenchymal stem cell
Intervention Description
islet of allograft and MSCs of autograft
Primary Outcome Measure Information:
Title
Exogenous insulin requirement
Time Frame
5
Title
Hemoglobin A1c
Time Frame
5
Title
Glucose and C-peptide levels
Time Frame
5
Secondary Outcome Measure Information:
Title
liver function
Time Frame
5
Title
kidney function
Time Frame
5
Title
Portal vein Ultrasound
Time Frame
1
Title
autoantibodies
Time Frame
5
Title
Complete Blood Count
Time Frame
5
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jianming Tan, Professor
Phone
008613375918000
Email
TANJM156@YAHOO.COM.CN
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jianming Tan, professor
Organizational Affiliation
Fuzhou General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fuzhou General Hospital
City
Fuzhou
State/Province
Fujian
ZIP/Postal Code
350025
Country
China
Individual Site Status
Recruiting
12. IPD Sharing Statement
Learn more about this trial
Cotransplantation of Islet and Mesenchymal Stem Cell in Type 1 Diabetic Patients
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