Effect of BM-MSCs on Early Graft Function Recovery After DCD Kidney Transplant.
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|ClinicalTrials.gov Identifier: NCT02563366|
Recruitment Status : Unknown
Verified September 2015 by Changxi Wang, First Affiliated Hospital, Sun Yat-Sen University.
Recruitment status was: Not yet recruiting
First Posted : September 30, 2015
Last Update Posted : September 30, 2015
|Condition or disease||Intervention/treatment||Phase|
|Kidney Transplantation Acute Kidney Tubular Necrosis||Other: BM-MSCs Other: Saline||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|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|
|Study Start Date :||November 2015|
|Estimated Primary Completion Date :||October 2017|
|Estimated Study Completion Date :||December 2017|
Experimental: MSCs group
Patients with early poor graft function receive allogeneic BM-MSCs at the dose of 1*10^6/kg every week for four consecutive doses.
BM-MSCs are from third-party healthy volunteer donors.
Other Name: allogeneic bone marrow-derived MSCs
Placebo Comparator: Control group
Patients with early poor graft function receive placebo of MSCs, i.e. saline every week for four consecutive doses.
Saline is the placebo of MSCs in this study.
- Estimated glomerular filtration rate [ Time Frame: 1 month ]eGFR at one month post transplant
- Estimated glomerular filtration rate [ Time Frame: 12 months ]eGFR up to 12 months post transplant
- Proportion of normal renal function recovery [ Time Frame: 12 months ]
- Time to renal function recovery (days) [ Time Frame: 12 months ]
- acute rejection rate [ Time Frame: 12 months ]Acute rejection rate according to Banff 2013 criteria up to 12 months post transplant
- patient and graft survival rate [ Time Frame: 12 months ]patient and graft survival rate up to 12 months post transplantation
- Incidence of severe adverse events [ Time Frame: 12 months ]Incidence of severe adverse events up to 12 months post transplantation
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02563366
|Contact: Changxi Wang, M.D., Ph.Dfirstname.lastname@example.org|
|Contact: Longshan Liu, M.D., Ph.Demail@example.com|
|The First Affiliated Hospital, Sun Yat-sen University|
|Guangzhou, Guangdong, China, 510080|
|Contact: Changxi Wang, M.D., Ph.D 86-20-87333428 firstname.lastname@example.org|
|Contact: Longshan Liu, M.D., Ph.D 86-20-87306082 email@example.com|
|Principal Investigator: Changxi Wang, M.D., Ph.D|
|Study Chair:||Changxi Wang, M.D., Ph.D||First Affiliated Hospital, Sun Yat-Sen University|