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1. 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

Author

Sitbon, Alexandre, Hauw-Berlemont, Caroline, Mebarki, Miryam, Heming, Nicholas, Mayaux, Julien, Diehl, Jean-Luc, Demoule, Alexandre, Annane, Djillali, Marois, Clémence, Demeret, Sophie, Weiss, Emmanuel, Voiriot, Guillaume, Fartoukh, Muriel, Constantin, Jean‐Michel, Mégarbane, Bruno, Plantefève, Gaëtan, Boucher-Pillet, Hélène, Churlaud, Guillaume, Cras, Audrey, Maheux, Camille, Pezzana, Chloé, Diallo, Mamadou Hassimiou, Lebbah, Said, Ropers, Jacques, Salem, Joe-Elie, Straus, Christian, Menasché, Philippe, Larghero, Jérôme, and Monsel, Antoine

Published
2024
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5. Effect of early granulocyte-colony-stimulating factor administration in the prevention of febrile neutropenia and impact on toxicity and efficacy of anti-CD19 CAR-T in patients with relapsed/refractory B-cell lymphoma

Author

Liévin, Raphaël, Di Blasi, Roberta, Morin, Florence, Galli, Eugenio, Allain, Vincent, De Jorna, Romain, Vercellino, Laetitia, Parquet, Nathalie, Mebarki, Miryam, Larghero, Jerome, de Kerviler, Eric, Madelaine, Isabelle, Caillat-Zucman, Sophie, Chevret, Sylvie, and Thieblemont, Catherine

Published
2022
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7. Treatment of COVID-19-associated ARDS with mesenchymal stromal cells: a multicenter randomized double-blind trial

Author

Monsel, Antoine, Hauw-Berlemont, Caroline, Mebarki, Miryam, Heming, Nicholas, Mayaux, Julien, Nguekap Tchoumba, Otriv, Diehl, Jean-Luc, Demoule, Alexandre, Annane, Djillali, Marois, Clémence, Demeret, Sophie, Weiss, Emmanuel, Voiriot, Guillaume, Fartoukh, Muriel, Constantin, Jean-Michel, Mégarbane, Bruno, Plantefève, Gaëtan, Malard-Castagnet, Stéphanie, Burrel, Sonia, Rosenzwajg, Michelle, Tchitchek, Nicolas, Boucher-Pillet, Hélène, Churlaud, Guillaume, Cras, Audrey, Maheux, Camille, Pezzana, Chloé, Diallo, Mamadou Hassimiou, Ropers, Jacques, Menasché, Philippe, and Larghero, Jérôme

Published
2022
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8. Success of donor‐derived CAR‐T cells after failure of autologous CD19 CAR‐T cells (tisagenlecleucel) in B‐cell acute lymphoblastic leukaemia

Author

Dourthe, Marie Emilie, primary, Yakouben, Karima, additional, David, Audrey, additional, Thouvenin, Sandrine, additional, Chaillou, Delphine, additional, Caillat‐Zucman, Sophie, additional, Cuffel, Alexis, additional, Tardy, Cléa, additional, Lainey, Elodie, additional, Caye‐Eude, Aurélie, additional, Arfeuille, Chloé, additional, Delaugerre, Constance, additional, Chaix‐Baudier, Marie‐Laure, additional, Naudin, Jérôme, additional, Auvin, Stéphane, additional, Bergaoui, Karim, additional, Merlat‐Guitard, Anne‐Isabelle, additional, De Jorna, Romain, additional, Mebarki, Miryam, additional, Dalle, Jean‐Hugues, additional, and Baruchel, André, additional

Published
2024
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17. Real-world characteristics of T-cell apheresis and clinical response to tisagenlecleucel in B-cell lymphoma

Author

Cuffel, Alexis, primary, Allain, Vincent, additional, Faivre, Lionel, additional, Di Blasi, Roberta, additional, Morin, Florence, additional, Vercellino, Laetitia, additional, Chevalier, Mathieu F., additional, Desnoyer, Aude, additional, de Jorna, Romain, additional, Madelaine, Isabelle, additional, Parquet, Nathalie, additional, Brignier, Anne C., additional, Thieblemont, Catherine, additional, Larghero, Jerome, additional, Caillat-Zucman, Sophie, additional, and Mebarki, Miryam, additional

Published
2022
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19. Positron emission tomography-imaging assessment for guiding strategy in patients with relapsed/refractory large B-cell lymphoma receiving CAR T cells

Author

Galtier, Jean, primary, Vercellino, Laetitia, additional, Chartier, Loic, additional, Olivier, Pierre, additional, Tabouret-Viaud, Claire, additional, Mesguich, Charles, additional, Di Blasi, Roberta, additional, Durand, Amandine, additional, Raffy, Léo, additional, Gros, François-Xavier, additional, Madelaine, Isabelle, additional, Meignin, Veronique, additional, Mebarki, Miryam, additional, Rubio, Marie-Thérèse, additional, Feugier, Pierre, additional, Casasnovas, Olivier, additional, Meignan, Michel, additional, and Thieblemont, Catherine, additional

Published
2022
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20. Additional file 1 of Treatment of COVID-19-associated ARDS with mesenchymal stromal cells: a multicenter randomized double-blind trial

Author

Monsel, Antoine, Hauw-Berlemont, Caroline, Mebarki, Miryam, Heming, Nicholas, Mayaux, Julien, Nguekap Tchoumba, Otriv, Diehl, Jean-Luc, Demoule, Alexandre, Annane, Djillali, Marois, Cl��mence, Demeret, Sophie, Weiss, Emmanuel, Voiriot, Guillaume, Fartoukh, Muriel, Constantin, Jean-Michel, M��garbane, Bruno, Plantef��ve, Ga��tan, Malard-Castagnet, St��phanie, Burrel, Sonia, Rosenzwajg, Michelle, Tchitchek, Nicolas, Boucher-Pillet, H��l��ne, Churlaud, Guillaume, Cras, Audrey, Maheux, Camille, Pezzana, Chlo��, Diallo, Mamadou Hassimiou, Ropers, Jacques, Menasch��, Philippe, and Larghero, J��r��me

Abstract

Additional file 1: A detailed description of the methods and the full clinical trial protocol. Table S1. Quality-control characteristics of UC-MSCs used as treatment: identity and safety. Table S2. Quality-control characteristics of batch-1 UC-MSCs used as treatment: identity and safety. Table S3. Quality-control characteristics of batch-2 UC-MSCs used as treatment: identity and safety. Table S4. Evolution of respiratory characteristics from baseline (D0) to D28 Table S5. UC-MSCs posology per patient. Table S6. Subgroup analyses of the primary outcome. Table S7. Complete list of adverse events. Table S8. Summary of pre-specified infusion-associated adverse events for randomized subjects.

Published
2022
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21. Additional file 5 of Treatment of COVID-19-associated ARDS with mesenchymal stromal cells: a multicenter randomized double-blind trial

Author

Monsel, Antoine, Hauw-Berlemont, Caroline, Mebarki, Miryam, Heming, Nicholas, Mayaux, Julien, Nguekap Tchoumba, Otriv, Diehl, Jean-Luc, Demoule, Alexandre, Annane, Djillali, Marois, Cl��mence, Demeret, Sophie, Weiss, Emmanuel, Voiriot, Guillaume, Fartoukh, Muriel, Constantin, Jean-Michel, M��garbane, Bruno, Plantef��ve, Ga��tan, Malard-Castagnet, St��phanie, Burrel, Sonia, Rosenzwajg, Michelle, Tchitchek, Nicolas, Boucher-Pillet, H��l��ne, Churlaud, Guillaume, Cras, Audrey, Maheux, Camille, Pezzana, Chlo��, Diallo, Mamadou Hassimiou, Ropers, Jacques, Menasch��, Philippe, and Larghero, J��r��me

Subjects
virus diseases
Abstract

Additional file 5: Figure S4. Analysis of plasma SARS���CoV-2 RNA and N-antigenemia levels at baseline (D0) and D2, D4, D7, and D14 after starting infusions. Plasma SARS���CoV-2 RNA (by RT-PCR) and N-antigenemia in UC-MSC��� (n = 21, red) or placebo-treated (n = 24, blue) patients were quantified. Based on viral RNA levels (A), five (23.8%) UC-MSC��� and eight (33.3%) placebo-treated patients had detectable viremia on D0, while (B) N-antigenemia was positive for 20 (95.2%) and 22 (91.7%) patients, respectively. (C) Plasma SARS���CoV-2 NAg-level change from D0 to D14. Data are expressed as mean �� standard deviation. The percentage of viremic patients and N-antigenemia levels decreased sharply until D4 (A���C). No between-group difference was observed in terms of percentage of viremic patients and/or decline from D0 to D14. Red = UC-MSC group; blue = placebo group. D day, PaO2/FiO2 ratio of partial pressure of oxygen to fractional inspired oxygen, RT-PCR reverse transcription-polymerase chain reaction, SARS���CoV-2 severe acute respiratory syndrome coronavirus-2, UC-MSCs umbilical cord-derived mesenchymal stromal cells.

Published
2022
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22. Additional file 4 of Treatment of COVID-19-associated ARDS with mesenchymal stromal cells: a multicenter randomized double-blind trial

Author

Monsel, Antoine, Hauw-Berlemont, Caroline, Mebarki, Miryam, Heming, Nicholas, Mayaux, Julien, Nguekap Tchoumba, Otriv, Diehl, Jean-Luc, Demoule, Alexandre, Annane, Djillali, Marois, Cl��mence, Demeret, Sophie, Weiss, Emmanuel, Voiriot, Guillaume, Fartoukh, Muriel, Constantin, Jean-Michel, M��garbane, Bruno, Plantef��ve, Ga��tan, Malard-Castagnet, St��phanie, Burrel, Sonia, Rosenzwajg, Michelle, Tchitchek, Nicolas, Boucher-Pillet, H��l��ne, Churlaud, Guillaume, Cras, Audrey, Maheux, Camille, Pezzana, Chlo��, Diallo, Mamadou Hassimiou, Ropers, Jacques, Menasch��, Philippe, and Larghero, J��r��me

Abstract

Additional file 4: Figure S3. Analysis of plasma inflammatory cytokine, chemokine, growth factor, and biomarker concentrations on D0 (baseline), D2, D4, D7, and D14 after starting infusions. The figure reports the quantification results for 10 cytokines selected among the 48 sought in plasma samples from patients treated with UC-MSCs (n = 20) or placebo (n = 21). Data are log2 transformed. Box plots of PaO2/FiO2 ratios: internal horizontal lines are the medians, lower and upper box limits are the 25th and 75th interquartile range, respectively, vertical bars are drawn down to the 10th percentile and up to the 90th percentile. D day, IL interleukin. IP-10 interferon-gamma-induced protein-10, MCP monocyte chemoattractant protein, RAGE receptor for advanced glycation end products, SDF-1 stromal cell-derived factor-��, UC-MSCs umbilical cord-derived mesenchymal stromal cells.

Published
2022
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23. Additional file 3 of Treatment of COVID-19-associated ARDS with mesenchymal stromal cells: a multicenter randomized double-blind trial

Author

Monsel, Antoine, Hauw-Berlemont, Caroline, Mebarki, Miryam, Heming, Nicholas, Mayaux, Julien, Nguekap Tchoumba, Otriv, Diehl, Jean-Luc, Demoule, Alexandre, Annane, Djillali, Marois, Cl��mence, Demeret, Sophie, Weiss, Emmanuel, Voiriot, Guillaume, Fartoukh, Muriel, Constantin, Jean-Michel, M��garbane, Bruno, Plantef��ve, Ga��tan, Malard-Castagnet, St��phanie, Burrel, Sonia, Rosenzwajg, Michelle, Tchitchek, Nicolas, Boucher-Pillet, H��l��ne, Churlaud, Guillaume, Cras, Audrey, Maheux, Camille, Pezzana, Chlo��, Diallo, Mamadou Hassimiou, Ropers, Jacques, Menasch��, Philippe, and Larghero, J��r��me

Abstract

Additional file 3: Figure S2. Analysis of plasma inflammatory cytokines, chemokines, growth factors, and biomarkers at baseline (D0) and D2, D4, D7, and D14 after starting infusions. Concentrations of 48 cytokines were quantified in plasma from UC-MSC��� (n = 20) or placebo- treated (n = 21) patients. Statistical analyses with Wilcoxon rank-sum tests compared values between groups (A) and within each group (B and C) at each day indicated. Volcano plots were generated for each comparison to show the log2 fold-changes relative to placebo or D0, with statistical significance reported as ���log10 P-values. Significance, defined as P

Published
2022
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24. Additional file 2 of Treatment of COVID-19-associated ARDS with mesenchymal stromal cells: a multicenter randomized double-blind trial

Author

Monsel, Antoine, Hauw-Berlemont, Caroline, Mebarki, Miryam, Heming, Nicholas, Mayaux, Julien, Nguekap Tchoumba, Otriv, Diehl, Jean-Luc, Demoule, Alexandre, Annane, Djillali, Marois, Cl��mence, Demeret, Sophie, Weiss, Emmanuel, Voiriot, Guillaume, Fartoukh, Muriel, Constantin, Jean-Michel, M��garbane, Bruno, Plantef��ve, Ga��tan, Malard-Castagnet, St��phanie, Burrel, Sonia, Rosenzwajg, Michelle, Tchitchek, Nicolas, Boucher-Pillet, H��l��ne, Churlaud, Guillaume, Cras, Audrey, Maheux, Camille, Pezzana, Chlo��, Diallo, Mamadou Hassimiou, Ropers, Jacques, Menasch��, Philippe, and Larghero, J��r��me

Subjects
health care facilities, manpower, and services, respiratory tract diseases
Abstract

Additional file 2: Figure S1. Survival probabilities and SOFA scores. (A) Survival rates from D0 to D28 were comparable for the two groups (P = 0.63, log-rank test). (B) SOFA-score evolutions from D0 to D28 did not differ (P = 0.79, Wilcoxon test). Data are expressed as mean per day �� standard deviation. D day. SOFA Sequential Organ-Failure Assessment score. UC-MSCs umbilical cord-derived mesenchymal stromal cells.

Published
2022
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25. In utero treatment of myelomeningocele with allogenic umbilical cord-derived mesenchymal stromal cells in an ovine model

Author

Guilbaud, Lucie, Dugas, Anaïs, Weber, Mathilde, Deflers, Carole, Lallemant, Pauline, Lilin, Thomas, Adam, Clovis, Cras, Audrey, Mebarki, Miryam, Zérah, Michel, Faivre, Lionel, Larghero, Jérôme, Jouannic, Jean-Marie, Chiarabini, Thibault, Lacombe, Karine, Valin, Nadia, Service de Médecine Fœtale [CHU Trousseau], CHU Trousseau [APHP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Hopital Saint-Louis [AP-HP] (AP-HP), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Air Liquide [Siège Social], Centre d’Investigation Clinique en Biothérapies [CHU Pitié-Salpêtrière] (CIC-BT), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-CHU Pitié-Salpêtrière [AP-HP], Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Service de Neuropédiatrie [CHU Trousseau], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-CHU Trousseau [APHP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Sorbonne Université (SU), Centre de recherche biomédicale (CRBM), École nationale vétérinaire d'Alfort (ENVA)-Université Paris-Est (UPE), AP-HP Hôpital Bicêtre (Le Kremlin-Bicêtre), Institut Mondor de Recherche Biomédicale (IMRB), Institut National de la Santé et de la Recherche Médicale (INSERM)-IFR10-Université Paris-Est Créteil Val-de-Marne - Paris 12 (UPEC UP12), Imagine - Institut des maladies génétiques (IHU) (Imagine - U1163), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Paris (UP), Institut Pierre Louis d'Epidémiologie et de Santé Publique (iPLESP), Institut National de la Santé et de la Recherche Médicale (INSERM)-Sorbonne Université (SU), Centre d'investigation clinique Biothérapie [CHU Pitié-Salpêtrière] (CIC-BTi), Institut National de la Santé et de la Recherche Médicale (INSERM)-CHU Pitié-Salpêtrière [AP-HP], École nationale vétérinaire - Alfort (ENVA)-Université Paris-Est (UPE), and Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris Cité (UPCité)

Subjects
Fetal surgery, [SDV.MHEP.PED]Life Sciences [q-bio]/Human health and pathology/Pediatrics, Ovine model, Fetal stem cell, Mesenchymal stromal cells, Myelomeningocele, Umbilical cord, Spina bifida
Abstract

International audience; Purpose of the studyThe purpose of our study was to investigate the effects of ovine umbilical cord-derived mesenchymal stromal cells (UC-MSCs) seeded in a fibrin patch as an adjuvant therapy for fetal myelomeningocele repair in the ovine model.Materials and methodsMMC defects were surgically created at 75 days of gestation and repaired 15 days later with UC-MSCs patch or an acellular patch. At birth, motor function, tail movements, and voiding abilities were recorded. Histological and immunohistochemical analysis included study of MMC defect's healing, spinal cord, UC-MSCs survival, and screening for tumors.ResultsSix lambs were born alive in each group. There was no difference between the two groups on the median sheep locomotor rating score but all lambs in the control group had a score between lower than 3 compared to 50% in UC-MSCs group. There were more lambs with tail movements and voiding ability in UC-MSCs group (83% vs 0% and 50% vs 0%, respectively). gray matter area and large neurons density were higher in UC-MSCs group (2.5 vs 0.8 mm2 and 19.3 vs 1.6 neurons/mm2 of gray matter, respectively). Fibrosis thickness at the myelomeningocele scar level was reduced in UC-MSCs group (1269 µm vs 2624 µm). No tumors were observed.ConclusionFetal repair of myelomeningocele using allogenic UC-MSCs patch provides a moderate improvement in neurological functions, gray matter and neuronal preservation and prevented from fibrosis development at the myelomeningocele scar level.

Published
2021
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26. Development of a Human Umbilical Cord-derived Mesenchymal Stromal Cells-based Advanced Therapy Medicinal Product to treat immune and/or inflammatory diseases

Author

MEBARKI, Miryam, primary, Iglicki, Nathan, additional, Marigny, Céline, additional, Abadie, Camille, additional, Nicolet, Claire, additional, Churlaud, Guillaume, additional, Maheux, Camille, additional, Boucher, Hélène, additional, Monsel, Antoine, additional, Menasché, Philipe, additional, Larghero, Jérôme, additional, Faivre, Lionel, additional, and Cras, Audrey, additional

Published
2021
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27. Failure and out of Specification Manufacturing of Autologous CAR-T Cells Could be Associated with a High Concentration of Total Nucleated Cells, CD3 + Cells and Neutrophils in the Apheresis Product

Author

Cohet, Guillaume, NGO-Chin, Cedrik, Douki, Nadia, Desniaux, Marion, Cornu, Stellie, Nasone, Justine, Cras, Audrey, Faivre, Lionel, Parquet, Nathalie, Brignier, Anne, Menouche, Dehbia, Lesprit, Emmanuelle, Azar, Nabih, Belhocine, Ramdane, Madelaine, Isabelle, de JORNA, Romain, Larghero, Jerome, and Mebarki, Miryam

Published
2023
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29. Additional file 3 of Development of a human umbilical cord-derived mesenchymal stromal cell-based advanced therapy medicinal product to treat immune and/or inflammatory diseases

Author

Mebarki, Miryam, Iglicki, Nathan, Marigny, C��line, Abadie, Camille, Nicolet, Claire, Churlaud, Guillaume, Maheux, Camille, Boucher, H��l��ne, Monsel, Antoine, Menasch��, Philippe, Larghero, J��r��me, Faivre, Lionel, and Cras, Audrey

Abstract

Additional file 3. Antibodies used for UC-MSCs staining at basal state and after pro-inflammatory priming.

Published
2021
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30. Additional file 4 of Development of a human umbilical cord-derived mesenchymal stromal cell-based advanced therapy medicinal product to treat immune and/or inflammatory diseases

Author

Mebarki, Miryam, Iglicki, Nathan, Marigny, C��line, Abadie, Camille, Nicolet, Claire, Churlaud, Guillaume, Maheux, Camille, Boucher, H��l��ne, Monsel, Antoine, Menasch��, Philippe, Larghero, J��r��me, Faivre, Lionel, and Cras, Audrey

Abstract

Additional file 4. Summary of the manufacturing process steps: UC procurement, UC processing, UC removal, MSCs expansion until passage 2 (P2), MCS production, WCS manufacturing, ATMP manufacturing. P: passage, d: day.

Published
2021
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31. Additional file 6 of Development of a human umbilical cord-derived mesenchymal stromal cell-based advanced therapy medicinal product to treat immune and/or inflammatory diseases

Author

Mebarki, Miryam, Iglicki, Nathan, Marigny, C��line, Abadie, Camille, Nicolet, Claire, Churlaud, Guillaume, Maheux, Camille, Boucher, H��l��ne, Monsel, Antoine, Menasch��, Philippe, Larghero, J��r��me, Faivre, Lionel, and Cras, Audrey

Abstract

Additional file 6. Area under the curve (AUC) representing the UC-MSCs and BM-MSCs��� abilities to inhibit T-Lymphocyte proliferation, which allow to assess their immunomodulatory activity. P < 0.001, Welch���s test.

Published
2021
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32. Additional file 2 of Development of a human umbilical cord-derived mesenchymal stromal cell-based advanced therapy medicinal product to treat immune and/or inflammatory diseases

Author

Mebarki, Miryam, Iglicki, Nathan, Marigny, C��line, Abadie, Camille, Nicolet, Claire, Churlaud, Guillaume, Maheux, Camille, Boucher, H��l��ne, Monsel, Antoine, Menasch��, Philippe, Larghero, J��r��me, Faivre, Lionel, and Cras, Audrey

Subjects
inorganic chemicals, fungi, bacteria, equipment and supplies, complex mixtures
Abstract

Additional file 2. Cytokines used to mimic the pro-inflammatory environment in vitro.

Published
2021
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33. Additional file 1 of Development of a human umbilical cord-derived mesenchymal stromal cell-based advanced therapy medicinal product to treat immune and/or inflammatory diseases

Author

Mebarki, Miryam, Iglicki, Nathan, Marigny, C��line, Abadie, Camille, Nicolet, Claire, Churlaud, Guillaume, Maheux, Camille, Boucher, H��l��ne, Monsel, Antoine, Menasch��, Philippe, Larghero, J��r��me, Faivre, Lionel, and Cras, Audrey

Abstract

Additional file 1. Serological testing according to the European directive on tissue procurement. * UC collected during the COVID-19 pandemic.

Published
2021
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34. Additional file 5 of Development of a human umbilical cord-derived mesenchymal stromal cell-based advanced therapy medicinal product to treat immune and/or inflammatory diseases

Author

Mebarki, Miryam, Iglicki, Nathan, Marigny, C��line, Abadie, Camille, Nicolet, Claire, Churlaud, Guillaume, Maheux, Camille, Boucher, H��l��ne, Monsel, Antoine, Menasch��, Philippe, Larghero, J��r��me, Faivre, Lionel, and Cras, Audrey

Subjects
chemical and pharmacologic phenomena, hemic and immune systems
Abstract

Additional file 5. Negative controls of CD90, CD105, CD73, CD44, CD29, CD166, CD146, HLA-DR, HLA-ABC, CD40, CD80, CD86 markers expression. Fluorescence Minus One (FMO) expression of CD14, CD45, CD31 markers.

Published
2021
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37. Inferior In Vivo Osteogenesis and Superior Angiogeneis of Human Adipose-Derived Stem Cells Compared with Bone Marrow-Derived Stem Cells Cultured in Xeno-Free Conditions

Author

Brennan, Meadhbh A., primary, Renaud, Audrey, additional, Guilloton, Fabien, additional, Mebarki, Miryam, additional, Trichet, Valerie, additional, Sensebé, Luc, additional, Deschaseaux, Frederic, additional, Chevallier, Nathalie, additional, and Layrolle, Pierre, additional

Published
2017
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38. Le sepsis induit des défaillances métaboliques et mitochondriales dans les cellules souches musculaires le traitement par cellules souches mésenchymateuses permettant de contrer ces dysfonctions

Author

Rocheteau, Pierre, primary, Rocheteau, Pierre, additional, Chatre, Laurent, additional, Briand, David, additional, Mebarki, Miryam, additional, Jouvion, Grégory, additional, Bardon, Jean, additional, Sharshar, Tarek, additional, Ricchetti, Miria, additional, and Chretien, Fabrice, additional

Published
2016
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39. Failure and out of Specification Manufacturing of Autologous CAR-T Cells Could be Associated with a High Concentration of Total Nucleated Cells, CD3 +Cells and Neutrophils in the Apheresis Product

Author

Cohet, Guillaume, NGO-Chin, Cedrik, Douki, Nadia, Desniaux, Marion, Cornu, Stellie, Nasone, Justine, Cras, Audrey, Faivre, Lionel, Parquet, Nathalie, Brignier, Anne, Menouche, Dehbia, Lesprit, Emmanuelle, Azar, Nabih, Belhocine, Ramdane, Madelaine, Isabelle, de JORNA, Romain, Larghero, Jerome, and Mebarki, Miryam

Abstract

Manufacturing capacities of commercial autologous chimeric antigen receptor (CAR)-T cells have been significantly increased during the last years, allowing treatment of a larger patient cohort. However, this was associated with the emergence of several failures and out of specifications (OOS), resulting in treatment delay. The aim of our study was to identify early indicators related to apheresis products that can predict CAR-T cells manufacturing failure or OOS. To this end, we analyzed manipulation processes of cellular starting materials (conservation, freezing, cryopreservation) and quality controls (QC) including count and/or concentration of total nucleated cells (TNC), CD3 +, CD4 +, CD8 +cells, platelets, monocytes and neutrophils.

Published
2023
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40. Advanced therapy medicinal products: Regulatory framework, hospital and pharmaceutical circuits in Europe and France

Author

Mebarki, Miryam, Madelaine, Isabelle, Larghero, Jérôme, and de Jorna, Romain

Abstract

Advanced therapy medicinal products (ATMPs) represent a new class of biological medicines. The European regulation has classified ATMPs into three categories: gene therapy medicinal products, somatic cell therapy medicinal products, and Tissue-Engineered products. If one of these categories incorporates a medical device, the medicine is defined as a Combined ATMP. The specificity and complexity of these innovative drugs have required a complete reorganization of hospital and pharmaceutical circuits, from patient eligibility to drug administration. Indeed, increased interaction and collaboration between different healthcare professionals are essential in order to guarantee quality and safety of these innovative medicines.

Published
2021
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41. Positron emission tomography-imaging assessment for guiding strategy in patients with relapsed/refractory large B-cell lymphoma receiving CAR T cells.

Author

Galtier J, Vercellino L, Chartier L, Olivier P, Tabouret-Viaud C, Mesguich C, Di Blasi R, Durand A, Raffy L, Gros FX, Madelaine I, Meignin V, Mebarki M, Rubio MT, Feugier P, Casasnovas O, Meignan M, and Thieblemont C

Subjects
Humans, Lactate Dehydrogenases, Positron Emission Tomography Computed Tomography, Prognosis, Retrospective Studies, T-Lymphocytes metabolism, Lymphoma, Large B-Cell, Diffuse diagnostic imaging, Lymphoma, Large B-Cell, Diffuse therapy, Lymphoma, Large B-Cell, Diffuse metabolism, Positron-Emission Tomography methods, Immunotherapy
Abstract

The aim of this study was to evaluate the prognostic impact of the F-fluorodeoxyglucose positron emission tomography response at 1 month (M1) and 3 months (M3) after anti-CD19 chimeric antigen receptor (CAR) T-cell therapy in a multicenter cohort of 160 patients with relapsed/refractory large B-cell lymphomas (R/R LBCL). In total, 119 (75%) patients reached M1 evaluation; 64 (53%, 64/119) had a complete response (CR); 91% were Deauville Score (DS) 1-3. Progressionfree survival (PFS) and overall survival (OS) were significantly worse in patients with DS-5 at M1, than in patients with DS 1-3 (PFS hazard ratio [HR]=6.37, 95% confidence interval [CI]: 3.5-11.5 vs. OS HR=3.79, 95% CI: 1.7-8.5) and DS-4 (PFS HR=11.99, 95% CI: 5.0-28.9 vs. OS HR=12.49, 95% CI: 2.8-55.8). The 1-year PFS rates were 78.9% (95% CI: 58.9-89.9) for DS-4 at M1, similar to 67.3% (95% CI: 51.8-78.8) for patients with DS 1-3 at M1, very different to 8.6% (95% CI: 1.8-22.4) for DS-5, respectively. Only eight of 30 (26%) patients with DS-4 progressed. Response at M3 evaluated in 90 (57%) patients was prognostic for PFS with lower discrimination (HR=3.28, 95% CI: 1.5-7.0; P=0.003) but did not predict OS (HR=0.61, 95% CI: 0.2-2.3; P=0.45). Patients with a high baseline total metabolic tumor volume (TMTV) >80 mL had worse PFS (HR=2.05, 95% CI: 1.2-3.5; P=0.009) and OS (HR=4.52, 95% CI: 2.5-8.1; P<0.001) than patients with low TMTV. Multivariable analyses identified baseline elevated lactate dehydrogenase, DS-5, CAR T cells at M1 for PFS and baseline elevated lactate dehydrogenase, TMTV >80 mL, and DS-5 at M1 for OS. In conclusion, baseline TMTV and response at M1 strongly predicts outcomes of patients with R/R LBCL undergoing CAR T-cell therapy.

Published
2023
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