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

April 14, 2008
April 16, 2008
April 16, 2008
May 2008
May 2008   (Final data collection date for primary outcome measure)
Creatinine and creatinine clearance rate [ Time Frame: 5 ]
Same as current
No Changes Posted
  • 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 ]
Same as current
Not Provided
Not Provided
Mesenchymal Stem Cell Transplantation in the Treatment of Chronic Allograft Nephropathy
Mesenchymal Stem Cell Transplantation in the Treatment of Chronic Allograft Nephropathy
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.

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.

Phase 1
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Kidney Transplant
  • Chronic Allograft Nephropathy
Biological: mesenchymal stem cell
transplantation of mesenchymal stem cell
Other Name: MMF FK506
Experimental: 1
transplantation of mesenchymal stem cell
Intervention: Biological: mesenchymal stem cell
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Unknown status
Same as current
May 2010
May 2008   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 60 Years   (Adult)
Contact information is only displayed when the study is recruiting subjects
Not Provided
Not Provided
Fuzhou General Hospital
Not Provided
Principal Investigator: Jianming Tan T Jianming, professor Fuzhou General Hospital
Organ Transplant Institute, China
April 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP