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Mesenchymal Stem Cell Transplantation in the Treatment of Chronic Allograft Nephropathy

NCT ID: NCT00659620

Last Updated: 2008-04-16

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

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-05-31

Study Completion Date

2010-05-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Kidney Transplant Chronic Allograft Nephropathy

Keywords

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Kidney Transplant Chronic Allograft Nephropathy Mesenchymal Stem Cell infusion

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

transplantation of mesenchymal stem cell

Group Type EXPERIMENTAL

mesenchymal stem cell

Intervention Type BIOLOGICAL

transplantation of mesenchymal stem cell

Interventions

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mesenchymal stem cell

transplantation of mesenchymal stem cell

Intervention Type BIOLOGICAL

Other Intervention Names

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MMF FK506

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fuzhou General Hospital

OTHER

Sponsor Role lead

Responsible Party

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FUZHOU GENERAL HOSPITAL

Principal Investigators

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Jianming Tan T Jianming, professor

Role: PRINCIPAL_INVESTIGATOR

Fuzhou General Hospital

Locations

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Fuzhou General Hospital

Fuzhou, Fujian, China

Site Status

Countries

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China

Central Contacts

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Jianming Tan T Jianming, Professor

Role: CONTACT

Phone: 008613375918000

Email: [email protected]

Junqi Guo G Junqi, vicProfessor

Role: CONTACT

Phone: 008613960941458

Email: [email protected]

Facility Contacts

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Jianming Tan T Jianming, professor

Role: primary

Other Identifiers

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fuzhough0712

Identifier Type: -

Identifier Source: secondary_id

fuzhough0712

Identifier Type: -

Identifier Source: org_study_id