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

NCT ID: NCT02490020

Last Updated: 2015-07-03

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 260 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-31
• Study Completion Date: 2018-12-31

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.

Conditions

Disorder Related to Renal Transplantation; Renal Transplant Rejection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

iv of BMSC to prevent rejection

Routine treatment protocol(ATG 50mg\*3;MP 2.0g to Pred 30mg,then maintaining 5mg qd;MMF 1.0 bid from the first day after op,then maintaining 1-1.5g/d;Plus CNI from the third day after op)+BMSC iv(2\*10\^6cell/kg, 48h before op)

Group Type: EXPERIMENTAL

mesenchymal stem cell

Intervention Type: BIOLOGICAL

routine treatment protocol to prevent rejection

Routine treatment protocol(ATG 50mg\*3;MP 2.0g to Pred 30mg,then maintaining 5mg qd;MMF 1.0 bid from the first day after op,then maintaining 1-1.5g/d;Plus CNI from the third day after op)

Group Type: NO_INTERVENTION

No interventions assigned to this group

ia and iv of MSC to prevent rejection

Routine treatment protocol(ATG 50mg\*3;MP 2.0g to Pred 30mg,then maintaining 5mg qd;MMF 1.0 bid from the first day after op,then maintaining 1-1.5g/d;Plus CNI from the third day after op)+BMSC (iv 2\*10\^6cell/kg + ia 5\*10\^6cell, 48h before op)

Group Type: EXPERIMENTAL

mesenchymal stem cell

Intervention Type: BIOLOGICAL

routine treatment to prevent rejection

Routine treatment protocol(ATG 50mg\*3;MP 2.0g to Pred 30mg,then maintaining 5mg qd;MMF 1.0 bid from the first day after op,then maintaining 1-1.5g/d;Plus CNI from the third day after op)

Group Type: NO_INTERVENTION

No interventions assigned to this group

Routine CMR treatment plus MSC to prevent CMR

Routine CMR treatment protocol(MP as first line approach, ATG as second line approach,ATG be used to treat BPAR in 1 week after op)+MSC( iv 2\*10\^6cell/kg at d1,d7)

Group Type: EXPERIMENTAL

mesenchymal stem cell

Intervention Type: BIOLOGICAL

Routine CMR treatment to prevent CMR

Routine CMR treatment protocol(MP as first line approach, ATG as second line approach,ATG be used to treat BPAR in 1 week after op)

Group Type: NO_INTERVENTION

No interventions assigned to this group

Routine AMR treatment plus MSC to prevent AMR

Routine AMR treatment protocol(plasma exchange and IVIG as first line approach, anti-CD20 monoclonal antibody as second line approach)+MSC( iv 2\*10\^6cell/kg at d1,d7)

Group Type: EXPERIMENTAL

mesenchymal stem cell

Intervention Type: BIOLOGICAL

Routine AMR treatment to prevent AMR

Routine AMR treatment protocol(plasma exchange and IVIG as first line approach, anti-CD20 monoclonal antibody as second line approach)

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

mesenchymal stem cell

Intervention Type: BIOLOGICAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zhujiang Hospital

OTHER

Sponsor Role: collaborator

The Second Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine

OTHER

Sponsor Role: collaborator

Qipeng Sun

OTHER

Sponsor Role: lead

Responsible Party

Qipeng Sun

MD

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Qiquan Sun, MD,PhD

Role: STUDY_DIRECTOR

Third Affiliated Hospital, Sun Yat-Sen University

References

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.

Reference Type: DERIVED

PMID: 29514693 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 29145879 (View on PubMed)

Other Identifiers

zssy20150624

Identifier Type: -

Identifier Source: org_study_id