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

Phase 1

• Conditions: Type 1 Diabetes Mellitus
• Interventions: Biological: cotransplantation of islet and mesenchymal stem cell

• Registration Number: NCT00646724
• Lead Sponsor: Fuzhou General Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-01
• Study First Submitted: 2008-03-25
• Study First Submitted QC: 2008-03-25
• Study First Posted: 2008-03-28
• Status Verified: 2011-06
• Last Update Submitted: 2011-06-15
• Last Update Posted: 2011-06-16
• Primary Completion: 2012-01
• Study Completion: 2014-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	cotransplantation of islet and mesenchymal stem cell	cotransplantation of islet and mesenchymal stem cell

Primary Outcome Measures

Name	Time	Method
Exogenous insulin requirement	5
Hemoglobin A1c	5
Glucose and C-peptide levels	5

Secondary Outcome Measures

Name	Time	Method
liver function	5
kidney function	5
Portal vein Ultrasound	1
autoantibodies	5
Complete Blood Count	5

Trial Locations

Locations (1)

Fuzhou General Hospital; 🇨🇳 Fuzhou, Fujian, China