Impact of mesenchymal stromal/stem cell infusions on circulating inflammatory biomarkers in COVID-19 patients: analysis of a phase I-IIa trial.
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Tonelli Roberto, Pischiutta Francesca, Elice Francesca, Zanier Elisa R, Grisendi Giulia, Astori Giuseppe, Samarelli Anna Valeria, Bruzzi Giulia, Manicardi Linda, Spano Carlotta, Nattino Giovanni, Signorini Fabiola, Bernardi Martina, Catanzaro Daniela, Merlo Anna, Lisi Ilaria, Pasetto Laura, Bonetto Valentina, Fiammenghi Laura, Boschi Laura, Guidi Simona, Candini Olivia, Zoerle Tommaso, Dander Erica, D'Amico Giovanna, De Pierri Ferruccio, Maur Michela, Pettorelli Elisa, Ruggieri Valentina, Cerri Stefania, Mari Giorgio, De Berardis Giorgia, Mighali Pasquale, Baschieri Maria Cristina, Lazzari Lorenza, Bambi Franco, Ciccocioppo Rachele, Clini Enrico, Dominici Massimo, RESCAT study group
Аннотация
METHODS: In the phase I/IIa RESCAT trial (May 2021-Feb 2022), patients with severe COVID-19 pneumonia received two intravenous MSC infusions and were compared to a control group (CTRL). To assess cytokine and biomarker responses, the MSC group was matched 1:2 with standard care patients (mCTRL) by age, gender, BMI, and PaO2/FiO2 (Nov 2020-Feb 2021). Random-effects linear regression evaluated cytokine and biomarker trends over time between MSC and control groups.
RESULTS: Seventeen patients (MSC = 5, CTRL = 2, mCTRL = 10) were analyzed. Two MSC infusions were feasible and safe, with all patients discharged on average 15 ± 3.7 days postsecond infusion. While IL1RA and IL18 levels significantly increased in CTRL-mCTRL patients (P = 0.044 and P = 0.032), MSC treatment averted these rises, showing a distinct trajectory, particularly for IL1RA. MSC treatment also reduced IL6 levels compared to CTRL-mCTRL, while both groups showed similar reductions in Long pentraxin. Furthermore, MSC infusions prevented the neurofilament light chain surge observed in CTRL patients.
CONCLUSIONS: MSC in COVID-19 patients resulted safe and feasible, effectively modulating inflammatory cytokines, in particular mitigating brain damage related biomarker, suggesting both reduced inflammation and a potential neurological protection.