@article{d7c8d4b3d43244a28de02cb782f97558,
title = "Pharmacological effects of ex vivo mesenchymal stem cell immunotherapy in patients with acute kidney injury and underlying systemic inflammation",
abstract = "Mesenchymal stem cells (MSCs) have natural immunoregulatory functions that have been explored for medicinal use as a cell therapy with limited success. A phase Ib study was conducted to evaluate the safety and immunoregulatory mechanism of action of MSCs using a novel ex vivo product (SBI-101) to preserve cell activity in patients with severe acute kidney injury. Pharmacological data demonstrated MSC-secreted factor activity that was associated with anti-inflammatory signatures in the molecular and cellular profiling of patient blood. Systems biology analysis captured multicompartment effects consistent with immune reprogramming and kidney tissue repair. Although the study was not powered for clinical efficacy, these results are supportive of the therapeutic hypothesis, namely, that treatment with SBI-101 elicits an immunotherapeutic response that triggers an accelerated phenotypic switch from tissue injury to tissue repair. Ex vivo administration of MSCs, with increased power of testing, is a potential new biological delivery paradigm that assures sustained MSC activity and immunomodulation.",
keywords = "MSCs, adult stem cells, cellular therapy, clinical trials, cytokines, immunotherapy, lymphocytes, monocyte",
author = "Madhav Swaminathan and Nelson Kopyt and Atta, {Mohamed G.} and Jai Radhakrishnan and Kausik Umanath and Sunny Nguyen and Brian O'Rourke and Ashley Allen and Natalie Vaninov and Arno Tilles and Elizabeth LaPointe and Andrew Blair and Chris Gemmiti and Brian Miller and Biju Parekkadan and Barcia, {Rita N.}",
note = "Funding Information: S.N., B.O., A.A., N.V., A.T., E.L., A.B., C.G., and R.N.B. are/were employees and are equity shareholders of Sentien Biotechnologies. B.P. and B.M. are equity shareholders and inventors of the technology with licensed patents to Sentien for commercialization. M.G.A. is Principal Investigator for contracted institutional research with Sentien, GlaxoSmithKline, REATA, Bristol‐Myers Squibb, Alnyalm. J.R. and K.U. declared research grant Sentien Biotechnologies. Funding Information: We are grateful to all the study participants. We are also very thankful to the staff at the Novel Cell Therapy Lab, Cell Manipulation Core Facility at Dana‐Farber Cancer Institute. We would like to acknowledge Payal Garg and Katrina MacNeil for their contribution throughout the study, as well as all the staff at the participating sites. This work was partially funded by the National Institutes of Health National Institute of Diabetes and Digestive and Kidney Diseases (5R44DK085766). The clinical trial conducted in this study is titled “A Study of Cell Therapy for Subjects with Acute Kidney Injury Who Are Receiving Continuous Renal Replacement Therapy.” ClinicalTrials.gov Identifier: NCT03015623. Funding Information: We are grateful to all the study participants. We are also very thankful to the staff at the Novel Cell Therapy Lab, Cell Manipulation Core Facility at Dana-Farber Cancer Institute. We would like to acknowledge Payal Garg and Katrina MacNeil for their contribution throughout the study, as well as all the staff at the participating sites. This work was partially funded by the National Institutes of Health National Institute of Diabetes and Digestive and Kidney Diseases (5R44DK085766). The clinical trial conducted in this study is titled ?A Study of Cell Therapy for Subjects with Acute Kidney Injury Who Are Receiving Continuous Renal Replacement Therapy.? ClinicalTrials.gov Identifier: NCT03015623. Publisher Copyright: {\textcopyright} 2021 Sentien Biotechnologies Inc. STEM CELLS TRANSLATIONAL MEDICINE published by Wiley Periodicals LLC on behalf of AlphaMed Press.",
year = "2021",
month = dec,
doi = "10.1002/sctm.21-0043",
language = "English (US)",
volume = "10",
pages = "1588--1601",
journal = "Stem Cells Translational Medicine",
issn = "2157-6564",
publisher = "Oxford University Press",
number = "12",
}