Effect of BM-MSCs on Early Graft Function Recovery After DCD Kidney Transplant.

Kidney Transplantation Clinical Trial

Official title:

Effect of Bone Marrow-derived Mesenchymal Stem Cells (BM-MSCs) on Recovery of Poor Early Graft Function Post Kidney Transplantation From Chinese Donation After Citizen Death (DCD): A Multi-center Randomized Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02563366
• Other study ID #: MSCs-KTx-DCD-150925
• Status: Not yet recruiting
• Phase: Phase 1/Phase 2
• First received: September 26, 2015
• Last updated: September 28, 2015
• Start date: November 2015
• Est. completion date: December 2017

Study information

• Verified date: September 2015
• Source: First Affiliated Hospital, Sun Yat-Sen University
• Contact: Changxi Wang, M.D., Ph.D
• Phone: 86-20-87333428
• Email: wangchx[@]mail.sysu.edu.cn
• Is FDA regulated: No
• Health authority: China: Health and Family Planning Commission of Guangdong Province
• Study type: Interventional

Clinical Trial Summary

This study is designed to investigate whether allogeneic bone marrow-derived mesenchymal stem cells (BM-MSCs) can promote function recovery in patients with poor early graft function after kidney transplantation from Chinese Donation after Citizen Death (DCD). DCD kidney transplant recipients with poor early graft function (with or without dialysis) post transplant are equally randomized into MSCs group or control group. Patients in MSCs group are administered MSCs treatment. Allogeneic BM-MSCs (1*10^6/kg) from third party are given intravenously for four consecutive doses every week after enrollment. Patients in control group receive placebo. Renal allograft function (eGFR), rejection, patient/graft survival and severe adverse events up to 12 months post enrollment are monitored.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: December 2017
• Est. primary completion date: October 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Primary kidney transplantation

• Kidneys are from donation after Chinese citizen death

• Poor early graft function with or without dialysis after transplantation

• 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% or 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Kidney Tubular Necrosis
• Kidney Transplantation
• Kidney Tubular Necrosis, Acute

Intervention

Other:
• BM-MSCs
BM-MSCs are from third-party healthy volunteer donors.
• Saline
Saline is the placebo of MSCs in this study.

Locations

Country	Name	City	State
China	The First Affiliated Hospital, Sun Yat-sen University	Guangzhou	Guangdong

Sponsors (2)

Lead Sponsor	Collaborator
First Affiliated Hospital, Sun Yat-Sen University	Second Affiliated Hospital of Guangzhou Medical University

Country where clinical trial is conducted

China, 

References & Publications (1)

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]. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Estimated glomerular filtration rate	eGFR at one month post transplant	1 month	No
Secondary	Estimated glomerular filtration rate	eGFR up to 12 months post transplant	12 months	No
Secondary	Proportion of normal renal function recovery		12 months	No
Secondary	Time to renal function recovery (days)		12 months	No
Secondary	acute rejection rate	Acute rejection rate according to Banff 2013 criteria up to 12 months post transplant	12 months	No
Secondary	patient and graft survival rate	patient and graft survival rate up to 12 months post transplantation	12 months	No
Secondary	Incidence of severe adverse events	Incidence of severe adverse events up to 12 months post transplantation	12 months	Yes

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