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

Status
UNKNOWN
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02490020
Enrollment
260
Registered
2015-07-03
Start date
2016-01-31
Completion date
2018-12-31
Last updated
2015-07-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Disorder Related to Renal Transplantation, Renal Transplant Rejection

Keywords

Renal transplantation, mesenchymal stem cell, Transplantation Rejection, donation after cardiac death

Brief 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.

Interventions

BIOLOGICALmesenchymal stem cell

Sponsors

Zhujiang Hospital
CollaboratorOTHER
The Second Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine
CollaboratorOTHER
Qipeng Sun
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Numbers of participants enrolled into the MSC group and control groupup to one year80-100 cases will be enrolled to the group.
Incident rates of BPAR and DGF after renal transplantation with MSC prevention before operationup to one yearCases 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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 8, 2026