Phase 1 trial for treatment of COVID‐19 patients with pulmonary fibrosis using hESC‐IMRCs

Abstract

Immunity-and-matrix-regulatory cells derived from human embryonic stem cells safely and effectively treat mouse lung injury and fibrosis.

Is There an Effect of Fetal Mesenchymal Stem Cells in the Mother–Fetus Dyad in COVID-19 Pregnancies and Vertical Transmission?

“…Currently (December 21, 2020), results from seven single case studies and five small studies (7, 9, 12, 16, and 27 patients, respectively) have been published, where MSCs were employed as therapy on COVID-19 patients ( Feng et al, 2020 ; Liang et al, 2020 ; Meng et al, 2020 ; Scherger et al, 2020 ; Sengupta et al, 2020 ; Shu et al, 2020 ; Soler Rich et al, 2020 ; Tao et al, 2020 ; Yilmaz et al, 2020 ; Zengin et al, 2020 ; Zhang et al, 2020 ). The phase I clinical trial with the 27 patients ( Wu et al, 2020c ) with COVID-19 followed the first case study ( Wu et al, 2020a ) of infusion of MSC-like cells [called human embryonic stem cell-derived immunity- and matrix-regulatory cells ( Wu et al, 2020b )] that show higher immunomodulatory potential than standard adult MSCs. These results, although from few patients, suggest that intravenous infusion of MSCs in COVID-19 patients does not cause severe side effects.…”

Mesenchymal stem cell therapy for severe COVID-19

“… 14 , 15 The potential efficacy and safety of MSC treatment have also been evaluated in patients with ARDS. 16 – 19 Types of stem cell other than MSC, 34 such as human embryonic stem cell-derived immunity- and matrix-regulatory cells (hESC-IMRCs), 35 have also been employed to treat COVID-19 patients (Fig. 1 ).…”

“… 41 – 44 Very recently, Mirakaj et al found that patients who underwent MSC treatment, compared against control patients, experienced significantly lower lung damage (Murray score) upon discharge, had a higher survival rate to discharge, and had better recovery of pulmonary functions. 20 , 45 , 46 Apart from MSCs, Wu et al 35 showed that lung fibrotic lesions were decreased by transfusion of hESC-IMRCs in patients with pulmonary fibrosis.…”

“… ChiCTR2000031494 Shu L, et al 46 Phase 1, open-label, randomized, standard treatment-controlled trial Severe/Critical Umbilical cord 2 × 10 6 cells/kg IV 1 round 41 MSCs induced the clinical improvement. National Medical Products Administration of China Wu J, et al 35 Phase 1, prospective, nonrandomized, open-label cohort COVID-19 patients with lung fibrosis hESC-IMRCs 3 × 10 6 cells/kg IV 1–3 rounds 27 Lung fibrosis lesions were decreased. IRCT20200217046526N2 Hashermian SR, et al 39 Phase 1 ARDS Umbilical cord and placental 2 × 10 8 cells/round 3 rounds ((day 0, 2 and 4).…”

Introductory Chapter: Stem Cells - Do We Really Know Everything Already?

“…Those therapies may cause concern about safety but many clinical trials has been studying the safeness and efficacy of mesenchymal stem cells therapies. Most recent describes Phase 1 trial for treatment of COVID-19 patients with pulmonary fibrosis using hESC-IMRCs [14] in which none of the treated patients suffered any adverse events or abnormal responses related to cell therapy. This suggest that stem cell therapies has become more and more safe, popular and researchers discover every year new potential fields of treatment with usage of stem cells.…”