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Clinical Trials/NCT07005687
NCT07005687Not yet recruitingNot Applicable

Using MSCs for Chronic Active Antibody Mediated Rejection

Shahid Beheshti University of Medical Sciences0 sites10 target enrollmentStarted: December 1, 2027Last updated:
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Enrollment
10
Primary Endpoint
progression of chronicity index

Study Overview

Brief Summary

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.

Detailed Description

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 will receive treatment with autologous bone marrow-derived MSCs (3 × 106 cells/kg iv) after completion of standard therapy and will be followed for up to 12 months. The primary endpoints are safety by adverse events. Secondary endpoints include assessment of kidney graft function, immunological and histological changes related to AMR activity and chronicity assessed by conventional microscopy and molecular transcripts.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • chronic active antibody mediated rejection in kidney transplanted recipients

Exclusion Criteria

  • Not provided

Arms & Interventions

MSCs Derived

Other

Intervention: Stem Cells (Other)

Outcomes

Primary Outcomes

progression of chronicity index

Time Frame: one year after administration

Number of participants with treatment-related adverse events as assessed by kidney biopsy

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

nooshin dalili

MD

Shahid Beheshti University of Medical Sciences

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