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Treatment of COVID-19-associated ARDS with umbilical cord-derived mesenchymal stromal cells in the STROMA-CoV-2 multicenter randomized double-blind trial: long-term safety, respiratory function, and quality of life.

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Title: Treatment of COVID-19-associated ARDS with umbilical cord-derived mesenchymal stromal cells in the STROMA-CoV-2 multicenter randomized double-blind trial: long-term safety, respiratory function, and quality of life.
Authors: Sitbon A; Multidisciplinary Intensive Care Unit, Department of Anesthesiology-Critical Care and Perioperative Medicine, La Pitié-Salpêtrière Hospital, Assistance Publique-Hôpitaux de Paris (APHP) Sorbonne University, 47-83, boulevard de l'Hôpital, 75651, Paris Cedex 13, France., Hauw-Berlemont C; Intensive Care Unit, APHP-CUP, Hôpital Européen Georges-Pompidou, Université Paris Cité, 75015, Paris, France., Mebarki M; APHP, Hôpital Saint-Louis, Unité de Thérapie Cellulaire, Centre d'Investigation Clinique en Biothérapies CBT501, INSERM, Université Paris Cité, Paris, France., Heming N; FHU SEPSIS, Department of Intensive Care, Hôpital Raymond-Poincaré (APHP), Laboratory of Infection & Inflammation-INSERM U1173, Simone Veil School of Medicine, University Versailles Saint Quentin-University Paris Saclay, 92380, Garches, France., Mayaux J; APHP, Groupe Hospitalier Universitaire-Sorbonne Université, site Pitié-Salpêtrière, Service de Médecine Intensive et Réanimation (Département R3S), INSERM, UMRS1158 Neurophysiologie Respiratoire Expérimentale et Clinique, Sorbonne Université, Paris, France., Diehl JL; Intensive Care Unit, APHP-CUP, Hôpital Européen Georges-Pompidou, Université Paris Cité, 75015, Paris, France.; Innovative Therapies in Hemostasis, INSERM, Université Paris Cité, 75006, Paris, France.; Biosurgical Research Laboratory (Carpentier Foundation), APHP-CUP, Hôpital Européen Georges-Pompidou, 75015, Paris, France., Demoule A; APHP, Groupe Hospitalier Universitaire-Sorbonne Université, site Pitié-Salpêtrière, Service de Médecine Intensive et Réanimation (Département R3S), INSERM, UMRS1158 Neurophysiologie Respiratoire Expérimentale et Clinique, Sorbonne Université, Paris, France., Annane D; FHU SEPSIS, Department of Intensive Care, Hôpital Raymond-Poincaré (APHP), Laboratory of Infection & Inflammation-INSERM U1173, Simone Veil School of Medicine, University Versailles Saint Quentin-University Paris Saclay, 92380, Garches, France., Marois C; Neurological Intensive Care Unit, Department of Neurology, La Pitié-Salpêtrière Hospital, APHP, Sorbonne University, Paris, France.; Groupe de Recherche Clinique en REanimation et Soins Intensifs du Patient en Insuffisance Respiratoire aiguE (GRC-RESPIRE), Sorbonne Université, Paris, France., Demeret S; Neurological Intensive Care Unit, Department of Neurology, La Pitié-Salpêtrière Hospital, APHP, Sorbonne University, Paris, France.; Groupe de Recherche Clinique en REanimation et Soins Intensifs du Patient en Insuffisance Respiratoire aiguE (GRC-RESPIRE), Sorbonne Université, Paris, France., Weiss E; Department of Anesthesiology and Critical Care, Beaujon Hospital, DMU PARABOL, APHP Nord, Paris, France.; Center for Research on Inflammation, INSERM, Université Paris Cité, Paris, France., Voiriot G; Centre de Recherche Saint-Antoine UMRS_938 INSERM, Assistance Publique - Hôpitaux de Paris, Service de Médecine Intensive Réanimation, Hôpital Tenon, Sorbonne Université, Paris, France., Fartoukh M; Centre de Recherche Saint-Antoine UMRS_938 INSERM, Assistance Publique - Hôpitaux de Paris, Service de Médecine Intensive Réanimation, Hôpital Tenon, Sorbonne Université, Paris, France., Constantin JM; Multidisciplinary Intensive Care Unit, Department of Anesthesiology-Critical Care and Perioperative Medicine, La Pitié-Salpêtrière Hospital, Assistance Publique-Hôpitaux de Paris (APHP) Sorbonne University, 47-83, boulevard de l'Hôpital, 75651, Paris Cedex 13, France., Mégarbane B; Department of Medical and Toxicological Critical Care, Lariboisière Hospital, INSERM UMRS1144, University of Paris, Paris, France., Plantefève G; Service de Réanimation Polyvalente, Centre Hospitalier Victor Dupouy, 69, Rue du Lieutenant-Colonel Prud'hon, 95100, Argenteuil, France., Boucher-Pillet H; Centre MEARY de Thérapie Cellulaire et Génique, APHP, Hôpital Saint-Louis, Paris, France., Churlaud G; Centre MEARY de Thérapie Cellulaire et Génique, APHP, Hôpital Saint-Louis, Paris, France., Cras A; APHP, Hôpital Saint-Louis, Unité de Thérapie Cellulaire, Centre d'Investigation Clinique en Biothérapies CBT501, INSERM, Université Paris Cité, Paris, France.; INSERM UMR1140, Université Paris Cité, 75006, Paris, France., Maheux C; Centre MEARY de Thérapie Cellulaire et Génique, APHP, Hôpital Saint-Louis, Paris, France., Pezzana C; INSERM, UMR S 970, Paris Centre de Recherche Cardiovasculaire (PARCC), Université de Paris, Paris, France., Diallo MH; Clinical Research Unit, Pitié-Salpêtrière University Hospital, APHP, Paris, France., Lebbah S; Clinical Research Unit, Pitié-Salpêtrière University Hospital, APHP, Paris, France., Ropers J; Clinical Research Unit, Pitié-Salpêtrière University Hospital, APHP, Paris, France., Salem JE; Institut National de la Santé et de la Recherche Médicale (INSERM), Assistance Publique - Hôpitaux de Paris (AP-HP), Clinical Investigation Center (CIC-1901), Regional Pharmacovigilance Centre, Department of Pharmacology, Pitié-Salpêtrière Hospital, Sorbonne Université, Paris, France., Straus C; INSERM, UMRS1158 Neurophysiologie Respiratoire Expérimentale et Clinique; AP-HP, Groupe Hospitalier Universitaire APHP-Sorbonne Université, site Pitié-Salpêtrière, Département R3S (Respiration, Réanimation, Réadaptation Respiratoire, Sommeil), Service d'Explorations Fonctionnelles de la Respiration, de l'Exercice et de la Dyspnée, Sorbonne Université, 75013, Paris, France., Menasché P; INSERM UMR1140, Université Paris Cité, 75006, Paris, France.; Department of Cardiovascular Surgery, Hôpital Européen Georges-Pompidou, Paris, France., Larghero J; APHP, Hôpital Saint-Louis, Unité de Thérapie Cellulaire, Centre d'Investigation Clinique en Biothérapies CBT501, INSERM, Université Paris Cité, Paris, France.; Centre MEARY de Thérapie Cellulaire et Génique, APHP, Hôpital Saint-Louis, Paris, France., Monsel A; Multidisciplinary Intensive Care Unit, Department of Anesthesiology-Critical Care and Perioperative Medicine, La Pitié-Salpêtrière Hospital, Assistance Publique-Hôpitaux de Paris (APHP) Sorbonne University, 47-83, boulevard de l'Hôpital, 75651, Paris Cedex 13, France. antoine.monsel@gmail.com.; INSERM UMRS_959, Immunology-Immunopathology-Immunotherapy (I3), Sorbonne Université, 75013, Paris, France. antoine.monsel@gmail.com.; Biotherapy (CIC-BTi), Hôpital Pitié-Salpêtrière, APHP, 75651, Paris, France. antoine.monsel@gmail.com.
Corporate Authors: APHP STROMA–CoV‐2 Collaborative Research Group
Source: Stem cell research & therapy [Stem Cell Res Ther] 2024 Apr 19; Vol. 15 (1), pp. 109. Date of Electronic Publication: 2024 Apr 19.
Publication Type: Clinical Trial, Phase II; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't
Journal Info: Publisher: BioMed Central Country of Publication: England NLM ID: 101527581 Publication Model: Electronic Cited Medium: Internet ISSN: 1757-6512 (Electronic) Linking ISSN: 17576512 NLM ISO Abbreviation: Stem Cell Res Ther Subsets: MEDLINE
Database: MEDLINE Ultimate
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  Data: Treatment of COVID-19-associated ARDS with umbilical cord-derived mesenchymal stromal cells in the STROMA-CoV-2 multicenter randomized double-blind trial: long-term safety, respiratory function, and quality of life.
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  Data: <searchLink fieldCode="AU" term="%22Sitbon+A%22">Sitbon A</searchLink>; Multidisciplinary Intensive Care Unit, Department of Anesthesiology-Critical Care and Perioperative Medicine, La Pitié-Salpêtrière Hospital, Assistance Publique-Hôpitaux de Paris (APHP) Sorbonne University, 47-83, boulevard de l'Hôpital, 75651, Paris Cedex 13, France.<br /><searchLink fieldCode="AU" term="%22Hauw-Berlemont+C%22">Hauw-Berlemont C</searchLink>; Intensive Care Unit, APHP-CUP, Hôpital Européen Georges-Pompidou, Université Paris Cité, 75015, Paris, France.<br /><searchLink fieldCode="AU" term="%22Mebarki+M%22">Mebarki M</searchLink>; APHP, Hôpital Saint-Louis, Unité de Thérapie Cellulaire, Centre d'Investigation Clinique en Biothérapies CBT501, INSERM, Université Paris Cité, Paris, France.<br /><searchLink fieldCode="AU" term="%22Heming+N%22">Heming N</searchLink>; FHU SEPSIS, Department of Intensive Care, Hôpital Raymond-Poincaré (APHP), Laboratory of Infection & Inflammation-INSERM U1173, Simone Veil School of Medicine, University Versailles Saint Quentin-University Paris Saclay, 92380, Garches, France.<br /><searchLink fieldCode="AU" term="%22Mayaux+J%22">Mayaux J</searchLink>; APHP, Groupe Hospitalier Universitaire-Sorbonne Université, site Pitié-Salpêtrière, Service de Médecine Intensive et Réanimation (Département R3S), INSERM, UMRS1158 Neurophysiologie Respiratoire Expérimentale et Clinique, Sorbonne Université, Paris, France.<br /><searchLink fieldCode="AU" term="%22Diehl+JL%22">Diehl JL</searchLink>; Intensive Care Unit, APHP-CUP, Hôpital Européen Georges-Pompidou, Université Paris Cité, 75015, Paris, France.; Innovative Therapies in Hemostasis, INSERM, Université Paris Cité, 75006, Paris, France.; Biosurgical Research Laboratory (Carpentier Foundation), APHP-CUP, Hôpital Européen Georges-Pompidou, 75015, Paris, France.<br /><searchLink fieldCode="AU" term="%22Demoule+A%22">Demoule A</searchLink>; APHP, Groupe Hospitalier Universitaire-Sorbonne Université, site Pitié-Salpêtrière, Service de Médecine Intensive et Réanimation (Département R3S), INSERM, UMRS1158 Neurophysiologie Respiratoire Expérimentale et Clinique, Sorbonne Université, Paris, France.<br /><searchLink fieldCode="AU" term="%22Annane+D%22">Annane D</searchLink>; FHU SEPSIS, Department of Intensive Care, Hôpital Raymond-Poincaré (APHP), Laboratory of Infection & Inflammation-INSERM U1173, Simone Veil School of Medicine, University Versailles Saint Quentin-University Paris Saclay, 92380, Garches, France.<br /><searchLink fieldCode="AU" term="%22Marois+C%22">Marois C</searchLink>; Neurological Intensive Care Unit, Department of Neurology, La Pitié-Salpêtrière Hospital, APHP, Sorbonne University, Paris, France.; Groupe de Recherche Clinique en REanimation et Soins Intensifs du Patient en Insuffisance Respiratoire aiguE (GRC-RESPIRE), Sorbonne Université, Paris, France.<br /><searchLink fieldCode="AU" term="%22Demeret+S%22">Demeret S</searchLink>; Neurological Intensive Care Unit, Department of Neurology, La Pitié-Salpêtrière Hospital, APHP, Sorbonne University, Paris, France.; Groupe de Recherche Clinique en REanimation et Soins Intensifs du Patient en Insuffisance Respiratoire aiguE (GRC-RESPIRE), Sorbonne Université, Paris, France.<br /><searchLink fieldCode="AU" term="%22Weiss+E%22">Weiss E</searchLink>; Department of Anesthesiology and Critical Care, Beaujon Hospital, DMU PARABOL, APHP Nord, Paris, France.; Center for Research on Inflammation, INSERM, Université Paris Cité, Paris, France.<br /><searchLink fieldCode="AU" term="%22Voiriot+G%22">Voiriot G</searchLink>; Centre de Recherche Saint-Antoine UMRS_938 INSERM, Assistance Publique - Hôpitaux de Paris, Service de Médecine Intensive Réanimation, Hôpital Tenon, Sorbonne Université, Paris, France.<br /><searchLink fieldCode="AU" term="%22Fartoukh+M%22">Fartoukh M</searchLink>; Centre de Recherche Saint-Antoine UMRS_938 INSERM, Assistance Publique - Hôpitaux de Paris, Service de Médecine Intensive Réanimation, Hôpital Tenon, Sorbonne Université, Paris, France.<br /><searchLink fieldCode="AU" term="%22Constantin+JM%22">Constantin JM</searchLink>; Multidisciplinary Intensive Care Unit, Department of Anesthesiology-Critical Care and Perioperative Medicine, La Pitié-Salpêtrière Hospital, Assistance Publique-Hôpitaux de Paris (APHP) Sorbonne University, 47-83, boulevard de l'Hôpital, 75651, Paris Cedex 13, France.<br /><searchLink fieldCode="AU" term="%22Mégarbane+B%22">Mégarbane B</searchLink>; Department of Medical and Toxicological Critical Care, Lariboisière Hospital, INSERM UMRS1144, University of Paris, Paris, France.<br /><searchLink fieldCode="AU" term="%22Plantefève+G%22">Plantefève G</searchLink>; Service de Réanimation Polyvalente, Centre Hospitalier Victor Dupouy, 69, Rue du Lieutenant-Colonel Prud'hon, 95100, Argenteuil, France.<br /><searchLink fieldCode="AU" term="%22Boucher-Pillet+H%22">Boucher-Pillet H</searchLink>; Centre MEARY de Thérapie Cellulaire et Génique, APHP, Hôpital Saint-Louis, Paris, France.<br /><searchLink fieldCode="AU" term="%22Churlaud+G%22">Churlaud G</searchLink>; Centre MEARY de Thérapie Cellulaire et Génique, APHP, Hôpital Saint-Louis, Paris, France.<br /><searchLink fieldCode="AU" term="%22Cras+A%22">Cras A</searchLink>; APHP, Hôpital Saint-Louis, Unité de Thérapie Cellulaire, Centre d'Investigation Clinique en Biothérapies CBT501, INSERM, Université Paris Cité, Paris, France.; INSERM UMR1140, Université Paris Cité, 75006, Paris, France.<br /><searchLink fieldCode="AU" term="%22Maheux+C%22">Maheux C</searchLink>; 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INSERM, UMRS1158 Neurophysiologie Respiratoire Expérimentale et Clinique; AP-HP, Groupe Hospitalier Universitaire APHP-Sorbonne Université, site Pitié-Salpêtrière, Département R3S (Respiration, Réanimation, Réadaptation Respiratoire, Sommeil), Service d'Explorations Fonctionnelles de la Respiration, de l'Exercice et de la Dyspnée, Sorbonne Université, 75013, Paris, France.<br /><searchLink fieldCode="AU" term="%22Menasché+P%22">Menasché P</searchLink>; INSERM UMR1140, Université Paris Cité, 75006, Paris, France.; Department of Cardiovascular Surgery, Hôpital Européen Georges-Pompidou, Paris, France.<br /><searchLink fieldCode="AU" term="%22Larghero+J%22">Larghero J</searchLink>; APHP, Hôpital Saint-Louis, Unité de Thérapie Cellulaire, Centre d'Investigation Clinique en Biothérapies CBT501, INSERM, Université Paris Cité, Paris, France.; Centre MEARY de Thérapie Cellulaire et Génique, APHP, Hôpital Saint-Louis, Paris, France.<br /><searchLink fieldCode="AU" term="%22Monsel+A%22">Monsel A</searchLink>; Multidisciplinary Intensive Care Unit, Department of Anesthesiology-Critical Care and Perioperative Medicine, La Pitié-Salpêtrière Hospital, Assistance Publique-Hôpitaux de Paris (APHP) Sorbonne University, 47-83, boulevard de l'Hôpital, 75651, Paris Cedex 13, France. antoine.monsel@gmail.com.; INSERM UMRS_959, Immunology-Immunopathology-Immunotherapy (I3), Sorbonne Université, 75013, Paris, France. antoine.monsel@gmail.com.; Biotherapy (CIC-BTi), Hôpital Pitié-Salpêtrière, APHP, 75651, Paris, France. antoine.monsel@gmail.com.
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