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Mesenchymal Stem Cell Transplantation in the Treatment of Chronic Allograft Nephropathy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00659620
Recruitment Status : Unknown
Verified April 2008 by Organ Transplant Institute, China.
Recruitment status was:  Not yet recruiting
First Posted : April 16, 2008
Last Update Posted : April 16, 2008
Information provided by:
Organ Transplant Institute, China

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
Kidney Transplant Chronic Allograft Nephropathy 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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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 2008
Estimated Primary Completion Date : May 2008
Estimated Study Completion Date : May 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases

Arm Intervention/treatment
Experimental: 1
transplantation of mesenchymal stem cell
Biological: mesenchymal stem cell
transplantation of mesenchymal stem cell
Other Name: MMF FK506

Primary Outcome Measures :
  1. Creatinine and creatinine clearance rate [ Time Frame: 5 ]

Secondary Outcome Measures :
  1. Patient and graft survival [ Time Frame: At 1 years post-transplant ]. [ Time Frame: 5 ]
  2. The proportion of renal biopsy after 12 months [ Time Frame: 2 ]
  3. The incidence of infectious complications [ Time Frame: 5 ]
  4. Incidence of adverse events associated with MSC and immunosuppression [ Time Frame: 5 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00659620

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Contact: Jianming Tan T Jianming, Professor 008613375918000 DOCTORTJM@YAHOO.COM
Contact: Junqi Guo G Junqi, vicProfessor 008613960941458

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China, Fujian
Fuzhou General Hospital
Fuzhou, Fujian, China, 350025
Contact: Jianming Tan T Jianming, professor    008613375918000    doctortjm@YAHOO.COM   
Sponsors and Collaborators
Fuzhou General Hospital
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Principal Investigator: Jianming Tan T Jianming, professor Fuzhou General Hospital
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Responsible Party: FUZHOU GENERAL HOSPITAL Identifier: NCT00659620    
Other Study ID Numbers: fuzhough0712
First Posted: April 16, 2008    Key Record Dates
Last Update Posted: April 16, 2008
Last Verified: April 2008
Keywords provided by Organ Transplant Institute, China:
Kidney Transplant
Chronic Allograft Nephropathy
Mesenchymal Stem Cell infusion
Additional relevant MeSH terms:
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Kidney Diseases
Urologic Diseases