Induction Therapy With Autologous Mesenchymal Stem Cells for Kidney Allografts

Renal Transplant Rejection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00658073
• Other study ID #: MSC-K-2
• Status: Completed
• Phase: N/A
• First received: April 8, 2008
• Last updated: March 7, 2011
• Start date: March 2008
• Est. completion date: October 2010

Study information

• Verified date: February 2011
• Source: Fuzhou General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 165
• Est. completion date: October 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Renal Transplant Rejection

Intervention

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.
• kidney transplantation without MSC infusion
kidney transplantation with standard immunosuppressive treatment regime

Locations

Country	Name	City	State
China	Stem cell therapy center,Fuzhou General Hospital	Fuzhou	Fujian

Sponsors (1)

Lead Sponsor	Collaborator
Fuzhou General Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence rate of biopsy-proven acute rejection and early renal function recovery		At 1 year post-transplant	Yes
Secondary	Patient and graft survival and prevalence of adverse events		At 1 year post-transplant	Yes