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Mesenchymal Stem Cell Transplantation in the Treatment of Chronic Allograft Nephropathy

This study is not yet open for participant recruitment.
Verified by Organ Transplant Institute, China, April 2008

Sponsored by: Fuzhou General Hospital
Information provided by: Organ Transplant Institute, China
ClinicalTrials.gov Identifier: NCT00659620
  Purpose

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 Intervention Phase
Kidney Transplant
Chronic Allograft Nephropathy
Biological: mesenchymal stem cell
Phase I
Phase II

MedlinePlus related topics:   Kidney Transplantation   

ChemIDplus related topics:   Tacrolimus    Tacrolimus anhydrous   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study
Official Title:   Mesenchymal Stem Cell Transplantation in the Treatment of Chronic Allograft Nephropathy

Further study details as provided by Organ Transplant Institute, China:

Primary Outcome Measures:
  • Creatinine and creatinine clearance rate [ Time Frame: 5 ] [ Designated as safety issue: Yes ]

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

Estimated Enrollment:   20
Study Start Date:   May 2008
Estimated Study Completion Date:   May 2010
Estimated Primary Completion Date:   May 2008 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
1: Experimental
transplantation of mesenchymal stem cell
Biological: mesenchymal stem cell
transplantation of mesenchymal stem cell

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.

  Eligibility
Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00659620

Contacts
Contact: Jianming Tan T Jianming, Professor     008613375918000     DOCTORTJM@YAHOO.COM    
Contact: Junqi Guo G Junqi, vicProfessor     008613960941458     guojunq2002@yahoo.com.cn    

Locations
China, FUJIAN
Fuzhou General Hospital     Not yet recruiting
      FUZHOU, FUJIAN, China, 350025
      Contact: Jianming Tan T Jianming, professor     008613375918000     doctortjm@YAHOO.COM    

Sponsors and Collaborators
Fuzhou General Hospital

Investigators
Principal Investigator:     Jianming Tan T Jianming, professor     Fuzhou General Hospital    
  More Information


Responsible Party:   FUZHOU GENERAL HOSPITAL ( FUZHOU GENERAL HOSPITAL )
Study ID Numbers:   fuzhough0712, fuzhough0712
First Received:   April 14, 2008
Last Updated:   April 14, 2008
ClinicalTrials.gov Identifier:   NCT00659620
Health Authority:   China: State Food and Drug Administration;   United States: Federal Government

Keywords provided by Organ Transplant Institute, China:
Kidney Transplant  
Chronic Allograft Nephropathy  
Mesenchymal Stem Cell infusion  

Study placed in the following topic categories:
Urologic Diseases
Tacrolimus
Kidney Diseases

ClinicalTrials.gov processed this record on October 17, 2008




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