Induction Therapy With Autologous Mesenchymal Stem Cells for Kidney Allografts

NCT00658073 | Completed DMC

• 1 other identifier: MSC-K-2
• Study Type: interventional
• Target: 165
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Renal Transplant Rejection

Keywords

Kidney transplant; Mesenchymal stem cell (MSC)

Outcome Measures

Primary Outcomes (1)

• Incidence rate of biopsy-proven acute rejection and early renal function recovery

  At 1 year post-transplant

Secondary Outcomes (1)

• Patient and graft survival and prevalence of adverse events

  At 1 year post-transplant

Study Arms (3)

A

ACTIVE COMPARATOR

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

B

ACTIVE COMPARATOR

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

C

ACTIVE COMPARATOR

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

Interventions

Kidney transplantation with MSCs infusion PROCEDURE

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.

Also known as: MSCs induction plus a standard or a lower dose of CNI

A; B

kidney transplantation without MSC infusion PROCEDURE

kidney transplantation with standard immunosuppressive treatment regime

Also known as: Anti-IL2R induction therapy with standard dose of CNI

C

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fuzhou General Hospital: lead

Study Sites (1)

Stem cell therapy center,Fuzhou General Hospital

Fuzhou, Fujian, 350025, China

Location

Related Publications (1)

• Tan J, Wu W, Xu X, Liao L, Zheng F, Messinger S, Sun X, Chen J, Yang S, Cai J, Gao X, Pileggi A, Ricordi C. Induction therapy with autologous mesenchymal stem cells in living-related kidney transplants: a randomized controlled trial. JAMA. 2012 Mar 21;307(11):1169-77. doi: 10.1001/jama.2012.316.

  PMID: 22436957 DERIVED

MeSH Terms

Interventions

Kidney Transplantation; cni protein, Drosophila

Intervention Hierarchy (Ancestors)

Renal Replacement Therapy; Therapeutics; Organ Transplantation; Transplantation; Surgical Procedures, Operative; Urologic Surgical Procedures; Urogenital Surgical Procedures

Study Officials

• Jianming Tan, M.D and Ph.D

  Fuzhou General Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 8, 2008
• First Posted: April 14, 2008
• Study Start: March 1, 2008
• Primary Completion: September 1, 2010
• Study Completion: October 1, 2010
• Last Updated: March 8, 2011

Record last verified: 2011-02

Locations

CN (1)