STROMA-CoV-2
Umbilical cord-derived mesenchymal stromal cell therapy in SARS-CoV-2-associated acute respiratory distress syndrome (ARDS)
Project phases
Phase IIb trial (NCT043368)
Pr Antoine Monsel, Surgical Intensive Care Unit, Pitié-Salpêtrière Hospital, Paris, France.
The primary objective of the study was to demonstrate that intravenous administration of umbilical cord-derived mesenchymal stromal cells added to standard management improved resolution of acute respiratory distress syndrome associated with novel coronavirus compared to placebo added to standard management.
The primary endpoint was the respiratory efficacy of mesenchymal stromal cells injections in acute respiratory distress syndrome associated ti SARS-Cov-2-infection.
The respiratory efficacy will be judged primarily on the evolution of the PaO2/FiO2 ratio at day 7 after the start of treatment.
The STROMA-COV study was a randomized, controlled, multicenter, double-blind clinical trial comparing the addition of intravenous human mesenchymal stromal cell therapy to standard of care versus placebo in addition to standard of care in ARDS associated with SARS-CoV2.
Trial treatment(s)
- Experimental:
Mesenchymal stromal cells derived from human umbilical cord Wharton jelly as add-on therapy at a dose of 1 million / kg intravenously, administered at D1 - D3(±1d) - D5 (±1d)
- Placebo:
0.9% saline solution as add-on therapy, intravenously, at D1 - D3(±1d) - D5 (±1d)
Publication
Monsel A, Hauw-Berlemont C, Mebarki M, Heming N, Mayaux J, Nguekap Tchoumba O, Diehl JL, Demoule A, Annane D, Marois C, Demeret S, Weiss E, Voiriot G, Fartoukh M, Constantin JM, Mégarbane B, Plantefève G, Malard-Castagnet S, Burrel S, Rosenzwajg M, Tchitchek N, Boucher-Pillet H, Churlaud G, Cras A, Maheux C, Pezzana C, Diallo MH, Ropers J, Menasché P, Larghero J; APHP STROMA–CoV-2 Collaborative Research Group. Treatment of COVID-19-associated ARDS with mesenchymal stromal cells: a multicenter randomized double-blind trial.
Crit Care. 2022 Feb 21;26(1):48. doi: 10.1186/s13054-022-03930-4.
Read the article here.
Mebarki M, Iglicki N, Marigny C, Abadie C, Nicolet C, Churlaud G, Maheux C, Boucher H, Monsel A, Menasché P, Larghero J, Faivre L, Cras A. Development of a human umbilical cord-derived mesenchymal stromal cell-based advanced therapy medicinal product to treat immune and/or inflammatory diseases. Stem Cell Res Ther. 2021 Nov 13;12(1):571. doi: 10.1186/s13287-021-02637-7. PMID: 34774107; PMCID: PMC8590372.
Read the article here.