Effect of BM-MSCs in DCD Kidney Transplantation

September 25, 2015 updated by: Changxi Wang, First Affiliated Hospital, Sun Yat-Sen University

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510080
        • The First Affiliated Hospital, Sun Yat-sen University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Primary kidney transplantation
  2. Receiving induction therapy and combined immunosuppressive regimens (CNIs + MPA + steroids)
  3. 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:

  1. Secondary kidney transplantation
  2. Combined or multi-organ transplantation
  3. 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
  4. Panel reactive antibody (PRA)>20%
  5. CDC crossmatch is positive
  6. Donors or recipients are known hepatitis C antibody-positive or polymerase chain reaction (PCR) positive for hepatitis C
  7. Donors or recipients are known hepatitis B surface antigen-positive or PCR positive for hepatitis B
  8. Donors or recipients are known human immunodeficiency virus (HIV) infection
  9. Patients with active infection
  10. 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.
  11. Patients with severe cardiovascular dysfunction
  12. WBC<3*10^9/L or RBC <5g/dL
  13. Highly allergic constitution or having severe history of allergies.
  14. Patients with active peptic ulcer disease, chronic diarrhea, or gastrointestinal problem affect absorption
  15. Patients with a history of cancer within the last 5 years
  16. Prisoner or patients compulsorily detained (involuntarily incarcerated) for treatment or either a psychiatric or physical (e.g. infectious disease) illness

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: MSCs group

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.
Other: bone marrow-derived mesenchymal stem cells
BM-MSCs is harvested from third-party health volunteer donors.
Other Names:
  • BM-MSCs
Drug: Induction therapy (ATG or Basiliximab)
ATG, antithymocyte globulin; Basiliximab, anti-CD25 mAb. Recipients receive ATG or Basiliximab as induction therapy in both MSCs group and control group.
Other Names:
  • ATG or Basiliximab
Drug: Maintenance therapy (Low-dose CNI + MPA + steroids)
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.
Other Names:
  • Low-dose tacrolimus + Mycophenolic acid (MPA) + steroids
Placebo Comparator: Control group
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.
Drug: Induction therapy (ATG or Basiliximab)
ATG, antithymocyte globulin; Basiliximab, anti-CD25 mAb. Recipients receive ATG or Basiliximab as induction therapy in both MSCs group and control group.
Other Names:
  • ATG or Basiliximab
Drug: Maintenance therapy (Low-dose CNI + MPA + steroids)
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.
Other Names:
  • Low-dose tacrolimus + Mycophenolic acid (MPA) + steroids
Other: Saline
Saline as placebo of MSCs

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Estimated glomerular filtration rate
Time Frame: 1 month
eGFR at one month post-transplant
1 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Severe adverse events
Time Frame: 12 months
12 months
Patient survival
Time Frame: 12 months
12 months
Incidence of slow graft function
Time Frame: 12 months
12 months
Incidence of delayed graft function
Time Frame: 12 months
12 months
Proportion of normal renal function recovery
Time Frame: 12 months
12 months
Time to renal function recovery
Time Frame: 12 months
12 months
Renal graft survival
Time Frame: 12 months
12 months
Incidence of acute rejection
Time Frame: 12 months
12 months
Estimated glomerular filtration rate
Time Frame: 12 months
eGFR up to 12 months post-transplant
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

First Affiliated Hospital, Sun Yat-Sen University

Collaborators

Second Affiliated Hospital of Guangzhou Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2015

Primary Completion (Anticipated)

October 1, 2016

Study Completion (Anticipated)

October 1, 2017

Study Registration Dates

First Submitted

September 25, 2015

First Submitted That Met QC Criteria

September 25, 2015

First Posted (Estimate)

September 28, 2015

Study Record Updates

Last Update Posted (Estimate)

September 28, 2015

Last Update Submitted That Met QC Criteria

September 25, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MSCs-KTx-DCD-150924

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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