Mesenchymal Stem Cell Transplantation in the Treatment of Chronic Allograft Nephropathy

Sponsor
Fuzhou General Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT00659620
Collaborator
(none)
20
1
1
24
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Study Details

Study Description

Brief Summary

Mesenchymal Stem Cell (MSC) have been shown to have immunosuppressive and repairing properties. the investigators will infuse expanded MSC into patients who develop Chronic Allograft Nephropathy. The purpose of this study is to find out MSC is more effective in preventing organ rejection and maintaining kidney function.

Condition or Disease Intervention/Treatment Phase
  • Biological: mesenchymal stem cell
Phase 1/Phase 2

Detailed Description

Kidney transplantation is a common procedure in hospitals, but organ rejection and chronic nephrotoxicity are potential problems for the patient. Approximately ninety percent of the protocol biopsies of renal allografts, performed at 18 months post transplantation, show histological lesions of chronic calcineurin nephrotoxicity. Mesenchymal Stem Cell (MSC) has been shown to have immunosuppressive and repairing properties. Some patient in this study will also receive two infusions of expanded MSC. This study will evaluate the safety and effectiveness of MSC infusions in patients .

This study will last 2 years. Participants will be randomly assigned to receive either the full immunosuppressive therapy and MSC infusions (Group 1) or immunosuppressive therapy alone (Group 2). Patients will undergo MSC infusions at the start of the study on Day 0. One year post- infusions, patients will be evaluated. At Months 12 participants will undergo kidney biopsies. Blood collection will occur at regular intervals, Serum creatinine and the estimated creatinine clearance will be monthly recorded. The transplanted kidney function will be evaluated.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Mesenchymal Stem Cell Transplantation in the Treatment of Chronic Allograft Nephropathy
Study Start Date :
May 1, 2008
Anticipated Primary Completion Date :
May 1, 2008
Anticipated Study Completion Date :
May 1, 2010

Arms and Interventions

Arm Intervention/Treatment
Experimental: 1

transplantation of mesenchymal stem cell

Biological: mesenchymal stem cell
transplantation of mesenchymal stem cell
Other Names:
  • MMF FK506
  • Outcome Measures

    Primary Outcome Measures

    1. Creatinine and creatinine clearance rate [5]

    Secondary Outcome Measures

    1. Patient and graft survival [ Time Frame: At 1 years post-transplant ]. [5]

    2. The proportion of renal biopsy after 12 months [2]

    3. The incidence of infectious complications [5]

    4. Incidence of adverse events associated with MSC and immunosuppression [5]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 60 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Recipients of a renal allograft, Male and female patients age 18 to 60 years of age.

    • Ability to provide written informed consent.

    • The serum creatinine form 176umol/L(2mg/ml) to 440umol/L(5mg/ml)

    • Renal biopsy Criteria: chronic allograft nephropathy (Banff I-II).

    • Immunosuppressant:CNI and MMF and Sirolimus

    • Written informed consent, compliant with local regulations.

    Exclusion Criteria:
    • Recipients with leucopenia (WBC < 3000/mm³), thrombocytopenia (Thr < 100.000/mm³),or hyperlipidemia (Tot Chol > 300 mg/dl or Triglycerides > 300 mg/dl).

    • Recipients of multiple organs.

    • Pregnant women.

    • Previous history of malignancy

    • Active infection including hepatitis B, hepatitis C, HIV, or TB as determined by a positive skin test or clinical presentation, or under treatment for suspected TB.

    • Evidence of cardiovascular disease, existing congestive cardiac failure on physical exam and/or acute coronary syndrome in past 6 months.

    • Inadequate compliance to treatment.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Fuzhou General Hospital Fuzhou Fujian China 350025

    Sponsors and Collaborators

    • Fuzhou General Hospital

    Investigators

    • Principal Investigator: Jianming Tan T Jianming, professor, Fuzhou General Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00659620
    Other Study ID Numbers:
    • fuzhough0712
    • fuzhough0712
    First Posted:
    Apr 16, 2008
    Last Update Posted:
    Apr 16, 2008
    Last Verified:
    Apr 1, 2008
    Keywords provided by , ,
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Apr 16, 2008