A Perspective Multicenter Controlled Study On Application Of Mesenchymal Stem Cell(MSC) To Prevent Rejection After Renal Transplantation By Donation After Cardiac Death

Renal Transplant Rejection Clinical Trial

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02490020
• Other study ID #: zssy20150624
• Status: Enrolling by invitation
• Phase: Phase 1
• First received: June 29, 2015
• Last updated: July 2, 2015
• Start date: January 2016
• Est. completion date: December 2018

Study information

• Verified date: July 2015
• Source: Third Affiliated Hospital, Sun Yat-Sen University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China:Ethics Committee of Human Study at the Third Affiliated Hospital of Sun Yat-sen University
• Study type: Interventional

Clinical Trial Summary

Although donation after cardiac death(DCD) is the major source of renal transplantation in China, high incidence rate of rejection and delayed graft function(DGF) is existing due to the prolonged ischemia time. According to the previous single center study, mesenchymal stem cell (MSC) had an effect to prevent rejection and DGF after renal transplantation, but there was no perspective multicenter controlled study to confirm it. This perspective multicenter controlled study will focus on clarifying the key role of MSC applied via renal arterial or peripheral vein injection, to reduce the rejection and DGF after renal transplantation. The investigators have established GMP workshop and solid research foundation of transplant rejection. This study will provide a new reasonable way for immune induction of renal transplantation by DCD.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 260
• Est. completion date: December 2018
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

1. Study on prevention of MSC to rejection after transplantation

• Age between 18-60 years

• having the indication of renal transplantation

• having no absolute contraindication

• renal transplantation by donation after citizen death

• the first time to receive renal transplantation

• signed informed consent

2. Study on treatment of MSC to rejection after transplantation

• renal transplantation by donation after citizen death

• BPAR

• having no contraindication of renal biopsy

• signed informed consent

Exclusion Criteria:

• loss to follow-up

• serious adverse events

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Disorder Related to Renal Transplantation
• Renal Transplant Rejection

Intervention

Biological:
• mesenchymal stem cell

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Qipeng Sun	The Second Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine, Zhujiang Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Numbers of participants enrolled into the MSC group and control group	80-100 cases will be enrolled to the group.	up to one year	Yes
Primary	Incident rates of BPAR and DGF after renal transplantation with MSC prevention before operation	Cases enrolled into the group will be monitored renal function,renal biopsy and other opportunistic infection.The incident rates of DGF and BPAR will be calculated and compare with the control group.	up to one year	Yes