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

Type 1 Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00646724
• Other study ID #: fuzhough0712
• Secondary ID: fuzhough0712
• Status: Recruiting
• Phase: Phase 1/Phase 2
• First received: March 25, 2008
• Last updated: June 15, 2011
• Start date: January 2008
• Est. completion date: January 2014

Study information

• Verified date: June 2011
• Source: Fuzhou General Hospital
• Contact: Jianming Tan, Professor
• Phone: 008613375918000
• Email: TANJM156[@]YAHOO.COM.CN
• Is FDA regulated: No
• Health authority: China:Fujian Province branch of Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: January 2014
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes Mellitus

Intervention

Biological:
• cotransplantation of islet and mesenchymal stem cell
islet of allograft and MSCs of autograft

Locations

Country	Name	City	State
China	Fuzhou General Hospital	Fuzhou	Fujian

Sponsors (1)

Lead Sponsor	Collaborator
Fuzhou General Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Exogenous insulin requirement		5	No
Primary	Hemoglobin A1c		5	No
Primary	Glucose and C-peptide levels		5	No
Secondary	liver function		5	Yes
Secondary	kidney function		5	Yes
Secondary	Portal vein Ultrasound		1	Yes
Secondary	autoantibodies		5	No
Secondary	Complete Blood Count		5	Yes