Using MSCs for Chronic Active Antibody Mediated Rejection

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Conditions studied: Kidney Transplant Rejection

In brief

Mesenchymal stem cell (MSCs) therapy has already been studied in kidney transplant recipients (KTRs), and the available data showed that it is safe and well tolerated. The aim of this study was to evaluate the safety and efficacy of autologous MSCs in combination with standard therapy in KTRs with biopsy-proven chronic active antibody-mediated rejection (AMR). Patients with biopsy-proven chronic active AMR received treatment with autologous bone marrow-derived MSCs (3 × 106 cells/kg iv) after completion of standard therapy and were followed for up to 12 months. The primary endpoints were safety by assessment of adverse events. Secondary endpoints included assessment of kidney graft function, immunological and histological changes related to AMR activity and chronicity assessed by conventional microscopy and molecular transcripts. A total of 3 patients were enrolled in the study before it was terminated prematurely because of adverse events. We found that AMR did not improve in any of the patients after treatment with MSCs. In addition, serious adverse events were observed in one case when autologous MSCs therapy was administered in the late phase after kidney transplantation, which requires further elucidation.

Key facts

Study ID
NCT07005687
Run by
Shahid Beheshti University of Medical Sciences
People needed
10
Starts
2027-12-01
Expected to finish
2029-07-01
Last updated by the study team
2026-02-11

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

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Full record on ClinicalTrials.gov

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