Clinical trial NCT02490020: A Perspective Multicenter Controlled Study On Application Of Mesenchymal Stem Cell(MSC) To Prevent Rejection After Renal Transplantation By Donation After Cardiac Death
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Disorder Related to Renal Transplantation
Renal Transplant Rejection
Keywords: Renal transplantation
mesenchymal stem cell
Transplantation Rejection
donation after cardiac death
Lead sponsor: Third Affiliated Hospital, Sun Yat-Sen University
Sponsor class: OTHER
Collaborators: name: Zhujiang Hospital
name: The Second Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine
First posted: 2015-07-03
Enrollment: 260
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Numbers of participants enrolled into the MSC group and control group
timeFrame: up to one year
measure: Incident rates of BPAR and DGF after renal transplantation with MSC prevention before operation
timeFrame: up to one year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Third Affiliated Hospital, Sun Yat-Sen University
name: Qiquan Sun, MD,PhD
role: STUDY_DIRECTOR
References:
citation: Sun Q, Huang Z, Han F, Zhao M, Cao R, Zhao D, Hong L, Na N, Li H, Miao B, Hu J, Meng F, Peng Y, Sun Q. Allogeneic mesenchymal stem cells as induction therapy are safe and feasible in renal allografts: pilot results of a multicenter randomized controlled trial. J Transl Med. 2018 Mar 7;16(1):52. doi: 10.1186/s12967-018-1422-x.
citation: Sun Q, Hong L, Huang Z, Na N, Hua X, Peng Y, Zhao M, Cao R, Sun Q. Allogeneic mesenchymal stem cell as induction therapy to prevent both delayed graft function and acute rejection in deceased donor renal transplantation: study protocol for a randomized controlled trial. Trials. 2017 Nov 16;18(1):545. doi: 10.1186/s13063-017-2291-y.