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Effect of BM-MSCs in DCD Kidney Transplantation

Primary Purpose

Kidney Transplantation, Acute Kidney Tubular Necrosis

Status

Unknown status

Phase

Phase 1

Locations

China

Study Type

Interventional

Intervention

bone marrow-derived mesenchymal stem cells

Saline

Induction therapy (ATG or Basiliximab)

Maintenance therapy (Low-dose CNI + MPA + steroids)

About this trial

This is an interventional treatment trial for Kidney Transplantation focused on measuring kidney transplantation, mesenchymal stem cell, donation after citizen's death, ischemia reperfusion injury, renal function recovery

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Primary kidney transplantation
Receiving induction therapy and combined immunosuppressive regimens (CNIs + MPA + steroids)
Patient is willing and capable of giving written informed consent for study participation and able to participate in the study for 12 months

Exclusion Criteria:

Secondary kidney transplantation
Combined or multi-organ transplantation
Women who are pregnant, intend to become pregnant in the next 1 years, breastfeeding, or have a positive pregnancy test on enrollment or prior to study medication administration
Panel reactive antibody (PRA)>20%
CDC crossmatch is positive
Donors or recipients are known hepatitis C antibody-positive or polymerase chain reaction (PCR) positive for hepatitis C
Donors or recipients are known hepatitis B surface antigen-positive or PCR positive for hepatitis B
Donors or recipients are known human immunodeficiency virus (HIV) infection
Patients with active infection
Recipients with a history of substance abuse (drugs or alcohol) within the past 6 months, or psychotic disorders that are not capable with adequate study follow-up.
Patients with severe cardiovascular dysfunction
WBC<3*10^9/L or RBC <5g/dL
Highly allergic constitution or having severe history of allergies.
Patients with active peptic ulcer disease, chronic diarrhea, or gastrointestinal problem affect absorption
Patients with a history of cancer within the last 5 years
Prisoner or patients compulsorily detained (involuntarily incarcerated) for treatment or either a psychiatric or physical (e.g. infectious disease) illness

Sites / Locations

The First Affiliated Hospital, Sun Yat-sen University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

MSCs group

Control group

Arm Description

Allogeneic bone marrow-derived mesenchymal stem cells (10^6/kg) from third party donors is intravenously given at day 0 (after renal artery reperfusion), day 7, day 14 and day 21.Induction therapy: ATG or Basiliximab; Maintenance therapy: low-dose Tacrolimus + mycophenolic acid + prednisone. The third-party MSCs have no similar HLA alleles of kidney donors, and have no HLA alleles specific to preformed anti-HLA antibodies in recipients prior to KTx.

Placebo (saline) is intravenously given at day 0 (after renal artery reperfusion), day 7, day 14 and day 21. Induction therapy: ATG or Basiliximab; Maintenance therapy: low-dose Tacrolimus + mycophenolic acid + prednisone.

Outcomes

Primary Outcome Measures

Estimated glomerular filtration rate

eGFR at one month post-transplant

Secondary Outcome Measures

Incidence of slow graft function

Incidence of delayed graft function

Proportion of normal renal function recovery

Time to renal function recovery

Patient survival

Renal graft survival

Incidence of acute rejection

Severe adverse events

Estimated glomerular filtration rate

eGFR up to 12 months post-transplant

Full Information

NCT ID

NCT02561767

First Posted

September 25, 2015

Last Updated

September 25, 2015

Sponsor

First Affiliated Hospital, Sun Yat-Sen University

Collaborators

Second Affiliated Hospital of Guangzhou Medical University

1. Study Identification

Unique Protocol Identification Number

NCT02561767

Brief Title

Effect of BM-MSCs in DCD Kidney Transplantation

Official Title

The Efficacy and Safety of Bone Marrow-derived Mesenchymal Stem Cells in Kidney Transplantation From Chinese Donation After Citizen Death (DCD): A Multi-center Randomized Controlled Trial

Study Type

Interventional

2. Study Status

Record Verification Date

September 2015

Overall Recruitment Status

Unknown status

Study Start Date

October 2015 (undefined)

Primary Completion Date

October 2016 (Anticipated)

Study Completion Date

October 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

First Affiliated Hospital, Sun Yat-Sen University

Collaborators

Second Affiliated Hospital of Guangzhou Medical University

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

This study is designed to determine the efficacy and safety of allogeneic bone marrow-derived mesenchymal stem cells in kidney transplantation from Chinese donation after citizen's death (DCD). A pair uremia patients receiving kidney grafts from a same donor are randomized into two groups: MSCs group and control group. Besides routine induction therapy (ATG or Basiliximab) and maintenance immunosuppressive drugs (low-dose Tacrolimus + MPA + prednisone), patients in MSCs group are administered MSCs treatment (1*10^6/kg). Allogeneic bone marrow-derived MSCs (1*10^6/kg) are given intravenously at day 0 (post renal reperfusion during surgery), day 7, day 14 and day 21. The renal allograft function, rejection, patient/graft survival and severe adverse events within 12 months post-transplant are monitored.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Kidney Transplantation, Acute Kidney Tubular Necrosis

Keywords

kidney transplantation, mesenchymal stem cell, donation after citizen's death, ischemia reperfusion injury, renal function recovery

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

MSCs group

Arm Type

Experimental

Arm Description

Arm Title

Control group

Arm Type

Placebo Comparator

Arm Description

Intervention Type

Other

Intervention Name(s)

bone marrow-derived mesenchymal stem cells

Other Intervention Name(s)

BM-MSCs

Intervention Description

BM-MSCs is harvested from third-party health volunteer donors.

Intervention Type

Other

Intervention Name(s)

Saline

Intervention Description

Saline as placebo of MSCs

Intervention Type

Drug

Intervention Name(s)

Induction therapy (ATG or Basiliximab)

Other Intervention Name(s)

ATG or Basiliximab

Intervention Description

ATG, antithymocyte globulin; Basiliximab, anti-CD25 mAb. Recipients receive ATG or Basiliximab as induction therapy in both MSCs group and control group.

Intervention Type

Drug

Intervention Name(s)

Maintenance therapy (Low-dose CNI + MPA + steroids)

Other Intervention Name(s)

Low-dose tacrolimus + Mycophenolic acid (MPA) + steroids

Intervention Description

Maintenance immunosuppressive therapy consists of low-dose tacrolimus and mycophenolic acid and steroids. Recipients receive the same maintenance therapy in both MSCs group and control group.

Primary Outcome Measure Information:

Title

Estimated glomerular filtration rate

Description

eGFR at one month post-transplant

Time Frame

1 month

Secondary Outcome Measure Information:

Title

Incidence of slow graft function

Time Frame

12 months

Title

Incidence of delayed graft function

Time Frame

12 months

Title

Proportion of normal renal function recovery

Time Frame

12 months

Title

Time to renal function recovery

Time Frame

12 months

Title

Patient survival

Time Frame

12 months

Title

Renal graft survival

Time Frame

12 months

Title

Incidence of acute rejection

Time Frame

12 months

Title

Severe adverse events

Time Frame

12 months

Title

Estimated glomerular filtration rate

Description

eGFR up to 12 months post-transplant

Time Frame

12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Primary kidney transplantation Receiving induction therapy and combined immunosuppressive regimens (CNIs + MPA + steroids) Patient is willing and capable of giving written informed consent for study participation and able to participate in the study for 12 months Exclusion Criteria: Secondary kidney transplantation Combined or multi-organ transplantation Women who are pregnant, intend to become pregnant in the next 1 years, breastfeeding, or have a positive pregnancy test on enrollment or prior to study medication administration Panel reactive antibody (PRA)>20% CDC crossmatch is positive Donors or recipients are known hepatitis C antibody-positive or polymerase chain reaction (PCR) positive for hepatitis C Donors or recipients are known hepatitis B surface antigen-positive or PCR positive for hepatitis B Donors or recipients are known human immunodeficiency virus (HIV) infection Patients with active infection Recipients with a history of substance abuse (drugs or alcohol) within the past 6 months, or psychotic disorders that are not capable with adequate study follow-up. Patients with severe cardiovascular dysfunction WBC<3*10^9/L or RBC <5g/dL Highly allergic constitution or having severe history of allergies. Patients with active peptic ulcer disease, chronic diarrhea, or gastrointestinal problem affect absorption Patients with a history of cancer within the last 5 years Prisoner or patients compulsorily detained (involuntarily incarcerated) for treatment or either a psychiatric or physical (e.g. infectious disease) illness

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Changxi Wang, M.D., Ph.D

Phone

86-20-87333428

wangchx@mail.sysu.edu.cn

First Name & Middle Initial & Last Name or Official Title & Degree

Longshan Liu, M.D., Ph.D

Phone

86-20-87306082

liulshan@mail.sysu.edu.cn

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Changxi Wang, M.D., Ph.D

Organizational Affiliation

First Affiliated Hospital, Sun Yat-Sen University

Official's Role

Study Chair

Facility Information:

Facility Name

The First Affiliated Hospital, Sun Yat-sen University

City

Guangzhou

State/Province

Guangdong

ZIP/Postal Code

510080

Country

China

12. IPD Sharing Statement

Citations:

PubMed Identifier

23263506

Citation

Peng Y, Ke M, Xu L, Liu L, Chen X, Xia W, Li X, Chen Z, Ma J, Liao D, Li G, Fang J, Pan G, Xiang AP. Donor-derived mesenchymal stem cells combined with low-dose tacrolimus prevent acute rejection after renal transplantation: a clinical pilot study. Transplantation. 2013 Jan 15;95(1):161-8. doi: 10.1097/TP.0b013e3182754c53. Erratum In: Transplantation. 2014 Mar 27;97(6):e37. Pan, Guanghui [added].

Results Reference

background

Links:

URL

http://www.ncbi.nlm.nih.gov/pubmed/23263506

Description

Previous publication

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Effect of BM-MSCs in DCD Kidney Transplantation

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