NCT03585855

Mesenchymal Stem Cell Transplantation in the Treatment of Chronic Antibody Mediated Kidney Graft Rejection (ABMR)

Terminated NA Last updated 25 July 2019

What this trial tests

NA trial testing MSC transplantation in Interventional in 4 participants. Terminated before completion.

Timeline

1 January 2019

Primary endpoint
23 July 2019

23 July 2019

Quick facts

Lead sponsor	University Medical Centre Ljubljana
Phase	NA
Status	Terminated
Study type	INTERVENTIONAL
Allocation	non randomized
Design	sequential
Masking	none
Primary purpose	treatment
Enrollment	4
Start date	1 January 2019
Primary completion	23 July 2019
Estimated completion	23 July 2019
Sites	1 location across Slovenia

Drugs / interventions tested

• MSC transplantation

Conditions studied

• Interventional — all drugs for Interventional →

Sponsor

University Medical Centre Ljubljana

Who can join

18 and older, any sex, with Interventional. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Transplant rejection is one of the biggest limitations in renal transplant procedures, where the kidney can undergo an acute, late acute, or chronic transplant rejection. With the advancement in transplantation protocols, acute survival of renal transplants has improved, but long-term survival is still unsatisfactory, as most of the renal transplants develop chronic graft rejection. Unfortunately, there is little the investigators know when it comes to improving long-term survival of renal transplants. Mesenchymal stem cells (MSC) have been shown to have immunosuppressive and repairing properties. The purpose of this study is to find out whether MSC in combination with standard therapy of antibody mediated rejection (ABMR) are more effective in preventing organ deterioration and maintaining kidney function.

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

1. The therapeutic challenge of late antibody-mediated kidney allograft rejection.
   Böhmig GA, Eskandary F, Doberer K, Halloran PF. · · 2019 · cited 87× · PMID 30955215 · DOI 10.1111/tri.13436
2. Preconditioning is an effective strategy for improving the efficiency of mesenchymal stem cells in kidney transplantation.
   Zhao L, Hu C, Han F, Cai F, et al · · 2020 · cited 20× · PMID 32448356 · DOI 10.1186/s13287-020-01721-8
3. Autologous Mesenchymal Stem Cells for Treatment of Chronic Active Antibody-Mediated Kidney Graft Rejection: Report of the Phase I/II Clinical Trial Case Series.
   Večerić-Haler Ž, Sever M, Kojc N, Halloran PF, et al · · 2022 · cited 12× · PMID 36484064 · DOI 10.3389/ti.2022.10772
4. Clinical Trial of Allogeneic Mesenchymal Stem Cell Therapy for Chronic Active Antibody-Mediated Rejection in Kidney Transplant Recipients Unresponsive to Rituximab and Intravenous Immunoglobulin.
   Ban TH, Lee S, Kim HD, Ko EJ, et al · · 2021 · cited 10× · PMID 33628269 · DOI 10.1155/2021/6672644
5. Narrative Review of Mesenchymal Stem Cell Therapy in Renal Diseases: Mechanisms, Clinical Applications, and Future Directions.
   Wang Y, Luo P, Wuren T. · · 2024 · cited 9× · PMID 39698513 · DOI 10.1155/sci/8658246
6. Case Report: Capillary Leak Syndrome With Kidney Transplant Failure Following Autologous Mesenchymal Stem Cell Therapy.
   Večerić-Haler Ž, Kojc N, Sever M, Zver S, et al · · 2021 · cited 7× · PMID 34368198 · DOI 10.3389/fmed.2021.708744