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Mesenchymal Stem Cell Transplantation in the Treatment of Chronic Allograft Nephropathy

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2008 by Organ Transplant Institute, China.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Organ Transplant Institute, China
ClinicalTrials.gov Identifier:
NCT00659620
First received: April 14, 2008
Last updated: NA
Last verified: April 2008
History: No changes posted
  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 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Mesenchymal Stem Cell Transplantation in the Treatment of Chronic Allograft Nephropathy

Resource links provided by NLM:

U.S. FDA Resources

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
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.

  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

No publications provided

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

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

Additional relevant MeSH terms:
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on June 18, 2013