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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2014-01-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Type 1 Diabetes Mellitus

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

cotransplantation of islet and mesenchymal stem cell

Group Type EXPERIMENTAL

cotransplantation of islet and mesenchymal stem cell

Intervention Type BIOLOGICAL

islet of allograft and MSCs of autograft

Interventions

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cotransplantation of islet and mesenchymal stem cell

islet of allograft and MSCs of autograft

Intervention Type BIOLOGICAL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No