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2. Safety and Efficacy of First-in-Man Intrathecal Transplantation of Human Astrocytes (AstroRx) in ALS Patients: Phase I/IIa Clinical Trial Results

Author

Gotkine, Marc, primary, Caraco, Yoseph, additional, Lerner, Yossef, additional, Blotnick, Simcha, additional, Wanounou, Maor, additional, Slutsky, Shalom Guy Guy, additional, Chebath, Judith, additional, Kuperstein, Graciela, additional, estrin, elena, additional, Ben-Hur, Tamir, additional, Hasson, Arik, additional, Molakandov, Kfir, additional, Sonnenfeld, Tehila, additional, Stark, Yafit, additional, Revel, Ariel, additional, Revel, Michel, additional, and Izrael, Michal, additional

Published
2022
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3. Additional file 1 of Safety and efficacy of first-in-man intrathecal injection of human astrocytes (AstroRx®) in ALS patients: phase I/IIa clinical trial results

Author

Gotkine, Marc, Caraco, Yoseph, Lerner, Yossef, Blotnick, Simcha, Wanounou, Maor, Slutsky, Shalom Guy, Chebath, Judith, Kuperstein, Graciela, Estrin, Elena, Ben-Hur, Tamir, Hasson, Arik, Molakandov, Kfir, Sonnenfeld, Tehila, Stark, Yafit, Revel, Ariel, Revel, Michel, and Izrael, Michal

Abstract

Additional file 1. Supplementary materials and methods.

Published
2023
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4. Additional file 2 of Safety and efficacy of first-in-man intrathecal injection of human astrocytes (AstroRx®) in ALS patients: phase I/IIa clinical trial results

Author

Gotkine, Marc, Caraco, Yoseph, Lerner, Yossef, Blotnick, Simcha, Wanounou, Maor, Slutsky, Shalom Guy, Chebath, Judith, Kuperstein, Graciela, Estrin, Elena, Ben-Hur, Tamir, Hasson, Arik, Molakandov, Kfir, Sonnenfeld, Tehila, Stark, Yafit, Revel, Ariel, Revel, Michel, and Izrael, Michal

Abstract

Additional file 2: Figure S1. ALSFRS-R slope for each patient in run-in, and 3-, 6- and 12-month follow up after AstroRx® treatment. Figure S2. Serum levels of Nfl for each patient. Table S1. List of serious TEAEs. Table S2. Treatment emergent adverse events (TEAE) reported in at least 20% of patients in both treatment arms. Table S3. AEs related to IT injection of AstroRx cells by lumbar puncture. Table S4. AEs related to immunosuppression by Mycophenolate Mofetil. Table S5. Slope analysis of handheld dynamometer megascore. Table S6. %SVC slopes analysis in run-in, and 3-, 6- and 12-month follow up after AstroRx® treatment

Published
2023
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