Effect of BM-MSCs on Early Graft Function Recovery After... | NCT02563366

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

NCT02563366

Sponsor

First Affiliated Hospital, Sun Yat-Sen University

Status

Unknown status

Last Update Posted

Sep 30, 2015Estimated

Enrollment

120Estimated

Phase

Phase 1Phase 2

Conditions

Kidney Transplantation
Acute Kidney Tubular Necrosis

Interventions

BM-MSCs
Saline

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2015

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2015

Primary Completion Date

Oct 2017Estimated

Completion Date

Dec 2017Estimated

First Submitted Date

Sep 26, 2015

First Submission Date that Met QC Criteria

Sep 28, 2015

First Posted Date

Sep 30, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 28, 2015

Last Update Posted Date

Sep 30, 2015Estimated

Name	Class
Second Affiliated Hospital of Guangzhou Medical University	OTHER

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

120Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
MSCs group	Experimental	Patients with early poor graft function receive allogeneic BM-MSCs at the dose of 1*10^6/kg every week for four consecutive doses.	Other: BM-MSCs
Control group	Placebo Comparator	Patients with early poor graft function receive placebo of MSCs, i.e. saline every week for four consecutive doses.	Other: Saline

Interventions

Name	Type	Description	Arm Group Labels	Other Names
BM-MSCs	Other	BM-MSCs are from third-party healthy volunteer donors.	MSCs group

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Estimated glomerular filtration rate	eGFR up to 12 months post transplant	12 months
Proportion of normal renal function recovery		12 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Changxi Wang, M.D., Ph.D	Contact	86-20-87333428		wangchx@mail.sysu.edu.cn
Longshan Liu, M.D., Ph.D	Contact	86-20-87306082		liulshan@mail.sysu.edu.cn

Overall Officials

Name	Affiliation	Role
Changxi Wang, M.D., Ph.D	First Affiliated Hospital, Sun Yat-Sen University	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The First Affiliated Hospital, Sun Yat-sen University		Guangzhou	Guangdong	510080	China

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
23263506	Background	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.

ID	Term
D007683	Kidney Tubular Necrosis, Acute
D051799	Delayed Graft Function
D015427	Reperfusion Injury

ID	Term
D058186	Acute Kidney Injury
D051437	Renal Insufficiency
D007674	Kidney Diseases
D014570	Urologic Diseases

ID	Term
D002712	Chlorides
D006851	Hydrochloric Acid
D017606	Chlorine Compounds
D007287	Inorganic Chemicals