Effect of BM-MSCs on Chronic AMR After Kidney Transplantation

Status Not yet recruiting

Clinical Trial Summary

This study is designed to investigate the efficacy and safety of allogeneic bone marrow-derived mesenchymal stem cells (BM-MSCs) on chronic antibody-mediated rejection (cAMR) after kidney transplantation. Chronic AMR is diagnosed according to Banff criteria 2013 based on renal graft biopsy and donor specific antibodies (DSA) examination. cAMR patients are assigned to MSCs group or control group. Patients in control group are prescribed to current desensitization therapy including at least one of the following treatments: plasmapheresis (PP), intravenous immunoglobulin (IVIG), rituximab or Bortezomib, depending on individual pathological and immunological features (eg. DSA type and titer) of each study subjects. Patients in MSCs group receive additional BM-MSCs therapy besides desensitization treatments as in control group. Allogeneic BM-MSCs (1*10^6/kg) are intravenously administered every two weeks for four consecutive doses. All cAMR patients are followed up for one year. Renal function, DSA level, pathological features, patient/graft survival, and severe adverse events are monitored during the follow-up period. Immunological features of patients in both groups are consecutively examined.

Clinical Trial Description

n/a

Study Design

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

Related Conditions & MeSH terms

Kidney Transplantation

Clinical Trial Details

NCT number	NCT02563340
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	November 2015
Completion date	November 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
Terminated	`NCT02417870` - Ultra-low Dose Subcutaneous IL-2 in Renal Transplantation	Phase 1/Phase 2
Completed	`NCT02560558` - Bela 8 Week Dosing	Phase 4
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
Completed	`NCT01655563` - Pharmacogenetic Trial of Tacrolimus After Pediatric Transplantation	Phase 2
Terminated	`NCT01436305` - Optimization of NULOJIX® Usage As A Means of Avoiding CNI and Steroids in Renal Transplantation	Phase 2