Mesenchymal stem cells offer no benefit in COVID-19

Although safe, administration of umbilical mesenchymal stem cells (MSCs) did not mitigate acute respiratory distress syndrome (ARDS) in COVID-19 patients in the REALIST-COVID study.

The phase 2 REALIST-COVID trial (NCT03042143) investigated an off-the-shelf product called ORBCEL-C, which consists of cryopreserved, allogeneic, human umbilical cord tissue-derived CD362-enriched MSCs, for the treatment of COVID-19-related ARDS. A total of 59 patients were randomised to receive 400 million ORBCEL-C MSCs (n=30) or Plasmalyte148 placebo (n=29). Dr Ellen Gorman (Queen’s University Belfast, UK) presented the data [1].

The primary efficacy endpoint, oxygenation index at day 7, was not met. The oxygenation level in the intervention arm (98.3) was similar to that in the placebo arm (96.6; mean difference 1.8; 95% CI -30.7 to 34.3; P=0.92). There was no difference over 14 days either. Likewise, both pulmonary and non-pulmonary function was identical across the groups. Safety data showed no significant differences in the number or severity of adverse events across the groups.

Dr Gorman concluded that although intravenous infusion of 400 million ORBCEL-C MSCs was safe in patients with moderate-to-severe ARDS due to COVID-19, there was no identified improvement in surrogates of pulmonary function in those patients.

1. Gorman E, et al. Repair of Acute Respiratory Distress Syndrome in COVID-19 by Stromal Cell Administration (REALIST-COVID) Phase 2 Randomised Controlled Trial. Session D94, ATS International Conference 2022, San Francisco, CA, USA, 13–18 May.

 

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Posted on 18 July 2022