- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00646724
Cotransplantation of Islet and Mesenchymal Stem Cell in Type 1 Diabetic Patients
June 15, 2011 updated by: Fuzhou General Hospital
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
30
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Jianming Tan, Professor
- Phone Number: 008613375918000
- Email: TANJM156@YAHOO.COM.CN
Study Locations
-
-
Fujian
-
Fuzhou, Fujian, China, 350025
- Recruiting
- Fuzhou General Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
cotransplantation of islet and mesenchymal stem cell
|
islet of allograft and MSCs of autograft
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Exogenous insulin requirement
Time Frame: 5
|
5
|
Hemoglobin A1c
Time Frame: 5
|
5
|
Glucose and C-peptide levels
Time Frame: 5
|
5
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
kidney function
Time Frame: 5
|
5
|
Portal vein Ultrasound
Time Frame: 1
|
1
|
liver function
Time Frame: 5
|
5
|
Complete Blood Count
Time Frame: 5
|
5
|
autoantibodies
Time Frame: 5
|
5
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Jianming Tan, professor, Fuzhou General Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2008
Primary Completion (Anticipated)
January 1, 2012
Study Completion (Anticipated)
January 1, 2014
Study Registration Dates
First Submitted
March 25, 2008
First Submitted That Met QC Criteria
March 25, 2008
First Posted (Estimate)
March 28, 2008
Study Record Updates
Last Update Posted (Estimate)
June 16, 2011
Last Update Submitted That Met QC Criteria
June 15, 2011
Last Verified
June 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- fuzhough0712
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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