Induction Therapy With Autologous Mesenchymal Stem Cells for Kidney Allografts

This study has been completed.
Sponsor:
Information provided by:
Fuzhou General Hospital
ClinicalTrials.gov Identifier:
NCT00658073
First received: April 8, 2008
Last updated: March 7, 2011
Last verified: February 2011
  Purpose

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


Condition Intervention
Renal Transplant Rejection
Procedure: Kidney transplantation with MSCs infusion
Procedure: kidney transplantation without MSC infusion

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Autologous Bone Marrow Mesenchymal Stem Cell Transplantation in Recipients of Living Kidney Allografts

Resource links provided by NLM:


Further study details as provided by Fuzhou General Hospital:

Primary Outcome Measures:
  • Incidence rate of biopsy-proven acute rejection and early renal function recovery [ Time Frame: At 1 year post-transplant ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Patient and graft survival and prevalence of adverse events [ Time Frame: At 1 year post-transplant ] [ Designated as safety issue: Yes ]

Enrollment: 165
Study Start Date: March 2008
Study Completion Date: October 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: 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 Name: Anti-IL2R induction therapy with standard dose of CNI

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.

  Eligibility

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

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00658073

Locations
China, Fujian
Stem cell therapy center,Fuzhou General Hospital
Fuzhou, Fujian, China, 350025
Sponsors and Collaborators
Fuzhou General Hospital
Investigators
Study Director: Jianming Tan, M.D and Ph.D Fuzhou General Hospital
  More Information

No publications provided by Fuzhou General Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jianming Tan M.D and Ph.D, Fuzhou General Hospital
ClinicalTrials.gov Identifier: NCT00658073     History of Changes
Other Study ID Numbers: MSC-K-2
Study First Received: April 8, 2008
Last Updated: March 7, 2011
Health Authority: China: Ministry of Health

Keywords provided by Fuzhou General Hospital:
Kidney transplant
Mesenchymal stem cell (MSC)

Additional relevant MeSH terms:
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 15, 2014