NCT00646724

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jan 2008

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 25, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 28, 2008

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
Last Updated

June 16, 2011

Status Verified

June 1, 2011

Enrollment Period

4 years

First QC Date

March 25, 2008

Last Update Submit

June 15, 2011

Conditions

Type 1 Diabetes Mellitus

Keywords

Islets of Langerhans TransplantationMesenchymal Stem CellsType 1 Diabetes Mellitus

Outcome Measures

Primary Outcomes (3)

  • Exogenous insulin requirement

    5

  • Hemoglobin A1c

    5

  • Glucose and C-peptide levels

    5

Secondary Outcomes (5)

  • liver function

    5

  • kidney function

    5

  • Portal vein Ultrasound

    1

  • autoantibodies

    5

  • Complete Blood Count

    5

Study Arms (1)

1

EXPERIMENTAL

cotransplantation of islet and mesenchymal stem cell

Biological: cotransplantation of islet and mesenchymal stem cell

Interventions

cotransplantation of islet and mesenchymal stem cellBIOLOGICAL

islet of allograft and MSCs of autograft

1

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fuzhou General Hospital

Fuzhou, Fujian, 350025, China

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Jianming Tan, professor

    Fuzhou General Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jianming Tan, Professor

CONTACT

008613375918000TANJM156@YAHOO.COM.CN

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 25, 2008

First Posted

March 28, 2008

Study Start

January 1, 2008

Primary Completion

January 1, 2012

Study Completion

January 1, 2014

Last Updated

June 16, 2011

Record last verified: 2011-06

Locations

CN(1)