Induction Therapy With Autologous Mesenchymal Stem Cells for Kidney Allografts

March 7, 2011 updated by: Fuzhou General Hospital

Autologous Bone Marrow Mesenchymal Stem Cell Transplantation in Recipients of Living Kidney Allografts

The goal of this study is to evaluate autologous MSCs as an alternative for antibody induction therapy in renal transplantation.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Renal transplantation is the most common and successful type of organ transplantation. Induction therapy with antibody plus the maintenance immunosuppressive agents have greatly improved graft survival in renal transplantation. Since mesenchymal stem cells(MSCs)have been used successfully to treat graft versus host disease and show immune modulation function both in vitro and in vivo and may help in repairing damaged tissue(s), we evaluate autologous MSCs as an alternative for antibody induction therapy. Moreover, we examine if MSCs could improve the recovery of early function in transplanted kidney.

Study Type

Interventional

Enrollment (Actual)

165

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Fujian
      • Fuzhou, Fujian, China, 350025
        • Stem cell therapy center,Fuzhou General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients must be between the ages of 18 and 60 years and meet the institution's criteria for renal transplantation for end-stage renal failure
  • Patient is receiving the first renal transplant
  • Patient is receiving a renal transplant only
  • Women who are of child bearing potential must have a negative pregnancy test (urine test is acceptable) and agree to use reliable contraception for 1 year following transplant
  • Willing to comply with the study visits
  • Be able to sign informed consent document.

Note: The subjects do not need to be local residents in order to be eligible for this trial, but must be willing to reside in the area, or within a four hour drive, for the first three months of the protocol so that we can monitor them closely in the early post transplant period.

Exclusion Criteria:

  • Previously received or is receiving an organ transplant other than a kidney
  • Significant liver disease, defined as having continuously elevated AST (SGOT) or ALT (SGPT) levels greater than 3 times the upper value of the normal range within 28 days prior to study entry
  • HIV infection.
  • Surface antigen positive for HBV.
  • Antibody positive for hepatitis C virus
  • Recipient or donor is positive for tuberculosis (TB), under treatment for suspected TB, or previously exposed to TB
  • Currently receiving an investigational drug or received an investigational drug within 30 days prior to transplant.
  • Currently receiving any immunosuppressive agent.
  • Clinically active bacterial, fungal, viral or parasitic infection
  • Evidence for immunologic memory against donor.
  • Recipients need antibody induction treatment before the operation.
  • Current cancer or a history of cancer within the 5 years prior to study entry.
  • Serious heart and lung diseases.
  • Patients who's RPR is positive
  • Pregnancy or breastfeeding.
  • Have no ability to communicate.
  • Any form of substance abuse, psychiatric disorder, or other condition that, in opinion of the investigator, may interfere with the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: A
Patients in Group A will receive MSCs instead of anti-interleukin 2 receptor antibody for induction therapy. The first MSCs infusion intravenously will be right at releasing renal artery clamp to establish allograft blood flow and the second infusion of MSCs will be performed two weeks after transplantation. Patients will receive standard regular immunosuppressive agents including calcineurin inhibitor, glucocorticoid, and MMF.
Procedure: Kidney transplantation with MSCs infusion
Patients in Group A will receive the first MSCs infusion intravenously within 24 hours after kidney transplant operation , and the second infusion of MSCs will be performed two weeks later.
Other Names:
  • MSCs induction plus a standard or a lower dose of CNI
Active Comparator: B
Patients in Group B will receive MSCs instead of anti-interleukin 2 receptor antibody for induction therapy. The first MSCs infusion intravenously will be right at releasing renal artery clamp to establish allograft blood flow and the second infusion of MSCs will be performed two weeks after transplantation. Patients will receive 80% less of calcineurin inhibitor than in Group A. Other immunosuppressive agents such as glucocorticoid and MMF remained the same doses as in Group A.
Procedure: Kidney transplantation with MSCs infusion
Patients in Group A will receive the first MSCs infusion intravenously within 24 hours after kidney transplant operation , and the second infusion of MSCs will be performed two weeks later.
Other Names:
  • MSCs induction plus a standard or a lower dose of CNI
Active Comparator: C
Patients in Group C will receive anti-interleukin 2 receptor antibody (Basiliximab)for induction therapy. Patients will receive the same doses of regular immunosuppressive agents including calcineurin inhibitor, glucocorticoid, and MMF as in Group A.
Procedure: kidney transplantation without MSC infusion
kidney transplantation with standard immunosuppressive treatment regime
Other Names:
  • Anti-IL2R induction therapy with standard dose of CNI

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence rate of biopsy-proven acute rejection and early renal function recovery
Time Frame: At 1 year post-transplant
At 1 year post-transplant

Secondary Outcome Measures

Outcome Measure
Time Frame
Patient and graft survival and prevalence of adverse events
Time Frame: At 1 year post-transplant
At 1 year post-transplant

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fuzhou General Hospital

Investigators

  • Study Director: Jianming Tan, M.D and Ph.D, Fuzhou General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2008

Primary Completion (Actual)

September 1, 2010

Study Completion (Actual)

October 1, 2010

Study Registration Dates

First Submitted

April 8, 2008

First Submitted That Met QC Criteria

April 11, 2008

First Posted (Estimate)

April 14, 2008

Study Record Updates

Last Update Posted (Estimate)

March 8, 2011

Last Update Submitted That Met QC Criteria

March 7, 2011

Last Verified

February 1, 2011

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • MSC-K-2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Renal Transplant Rejection

Clinical Trials on Kidney transplantation with MSCs infusion

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Cote d'Ivoire

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe