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Mesenchymal Stem Cell Transplantation in the Treatment of Chronic Allograft Nephropathy

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified April 2008 by Organ Transplant Institute, China.
Recruitment status was:  Not yet recruiting
Information provided by:
Organ Transplant Institute, China Identifier:
First received: April 14, 2008
Last updated: NA
Last verified: April 2008
History: No changes posted
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 1 Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

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

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

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

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
Experimental: 1
transplantation of mesenchymal stem cell
Biological: mesenchymal stem cell
transplantation of mesenchymal stem cell
Other Name: MMF FK506

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.


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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT00659620

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

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

Responsible Party: FUZHOU GENERAL HOSPITAL Identifier: NCT00659620     History of Changes
Other Study ID Numbers: fuzhough0712
Study First Received: April 14, 2008
Last Updated: April 14, 2008

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

Additional relevant MeSH terms:
Kidney Diseases
Urologic Diseases processed this record on September 21, 2017