Effect of BM-MSCs in DCD Kidney Transplantation

Status Not yet recruiting

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

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

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02561767
Study type	Interventional
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
Status	Not yet recruiting
Phase	Phase 1/Phase 2
Start date	October 2015
Completion date	October 2017

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT04910867` - APOL1 Genetic Testing Program for Living Donors	N/A
Completed	`NCT02723591` - To Compare the Effects of Immediate-release Tacrolimus and Astagraf XL on Donor-Specific Antibody (DSA) Formation and the Development of Immune Activation (IA) in de Novo Kidney Transplant Recipients	Phase 4
Completed	`NCT05945511` - Silent Gallbladder Stone in Kidney Transplantation Recipients: Should it be Treated?
Completed	`NCT02234349` - Bile Acids and Incretins in Pancreas Kidney Transplant Patients	N/A
Completed	`NCT04496401` - PK Study in Diabetic Transplant récipients : From Twice-daily Tacrolimus to Once-daily Extended-release Tacrolimus	Phase 4
Recruiting	`NCT05917795` - Endoscopic Sleeve Gastroplasty With Endomina® for the Treatment of Obesity in Kidney Transplant Candidates	N/A
Not yet recruiting	`NCT05934383` - Safety and Efficacy of Ultrasound Renal Denervation in Kidney Transplantation Patients With Uncontrolled Hypertension	N/A
Withdrawn	`NCT04936971` - Introduction of mTor Inhibitors and the Activation of the Cytomegalovirus (CMV) -Specific Cellular Immune Response	Phase 4
Not yet recruiting	`NCT04540640` - Oxygenated Machine Preservation in Kidney Transplantation	N/A
Not yet recruiting	`NCT03090828` - Economic Evaluation of an Education Platform for Patients With End-stage Renal Disease	N/A
Recruiting	`NCT02908139` - Noninvasive Perioperative Monitoring of Arterial Stiffness, Volume and Nutritional Status in Stable Renal Transplant Recipients	N/A
Completed	`NCT02560558` - Bela 8 Week Dosing	Phase 4
Terminated	`NCT02417870` - Ultra-low Dose Subcutaneous IL-2 in Renal Transplantation	Phase 1/Phase 2
Recruiting	`NCT02154815` - Pre-emptive Kidney Transplantation Quality of Life	N/A
Completed	`NCT02235571` - iChoose Decision Kidney Aid for End-Stage Renal Disease Patients	N/A
Enrolling by invitation	`NCT01905514` - ImPRoving Adherence to Immunosuppressive Therapy by Mobile Internet Application in Solid Organ Transplant Patients	N/A
Completed	`NCT02147210` - Chronic Transplant Glomerulopathy and Regulation of Expression of Ephrin B1	N/A
Recruiting	`NCT01699360` - The Biomarker for Immunosuppressive Agents Metabolism in Chinese Renal Transplant Recipients	Phase 4
Terminated	`NCT01436305` - Optimization of NULOJIX® Usage As A Means of Avoiding CNI and Steroids in Renal Transplantation	Phase 2
Completed	`NCT01655563` - Pharmacogenetic Trial of Tacrolimus After Pediatric Transplantation	Phase 2