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Randomized Controlled Trial
. 2021 Aug;21(8):2795-2809.
doi: 10.1111/ajt.16468. Epub 2021 Feb 22.

Third-party bone marrow-derived mesenchymal stromal cell infusion before liver transplantation: A randomized controlled trial

Federica Casiraghi  1 , Norberto Perico  1 , Manuel A Podestà  1   2 , Marta Todeschini  1 , Marco Zambelli  3 , Michele Colledan  3 , Stefania Camagni  3 , Stefano Fagiuoli  4 , Antonio D Pinna  5 , Matteo Cescon  5 , Valentina Bertuzzo  5 , Lorenzo Maroni  5 , Martino Introna  6 , Chiara Capelli  6 , Josee T Golay  6 , Marina Buzzi  7 , Marilena Mister  1 , Pamela Y R Ordonez  1 , Matteo Breno  1 , Caterina Mele  1 , Alessandro Villa  1 , Giuseppe Remuzzi  1 ; MSC-LIVER Study Group
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Free article
Randomized Controlled Trial

Third-party bone marrow-derived mesenchymal stromal cell infusion before liver transplantation: A randomized controlled trial

Federica Casiraghi et al. Am J Transplant. 2021 Aug.
Free article

Abstract

Mesenchymal stromal cells (MSC) have emerged as a promising therapy to minimize the immunosuppressive regimen or induce tolerance in solid organ transplantation. In this randomized open-label phase Ib/IIa clinical trial, 20 liver transplant patients were randomly allocated (1:1) to receive a single pretransplant intravenous infusion of third-party bone marrow-derived MSC or standard of care alone. The primary endpoint was the safety profile of MSC administration during the 1-year follow-up. In all, 19 patients completed the study, and none of those who received MSC experienced infusion-related complications. The incidence of serious and non-serious adverse events was similar in the two groups. Circulating Treg/memory Treg and tolerant NK subset of CD56bright NK cells increased slightly over baseline, albeit not to a statistically significant extent, in MSC-treated patients but not in the control group. Graft function and survival, as well as histologic parameters and intragraft expression of tolerance-associated transcripts in 1-year protocol biopsies were similar in the two groups. In conclusion, pretransplant MSC infusion in liver transplant recipients was safe and induced mild positive changes in immunoregulatory T and NK cells in the peripheral blood. This study opens the way for a trial on possible tolerogenic efficacy of MSC in liver transplantation. ClinicalTrials.gov identifier: NCT02260375.

Keywords: clinical research/practice; liver transplantation/hepatology; stem cells; tolerance.

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References

REFERENCES

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