Safety and efficacy of autologous non-hematopoietic enriched stem cell nebulization in COVID-19 patients: a randomized clinical trial, Abu Dhabi 2020

Abstract Background The novel SARS-CoV-2 has caused the coronavirus disease 2019 (COVID-19) pandemic. Currently, with insufficient worldwide vaccination rates, identifying treatment solutions to reduce the impact of the virus is urgently needed. Method An adaptive, multicentric, open-label, and rand...

Descripción completa

Guardado en:

Detalles Bibliográficos
Autores principales:	Yendry Ventura-Carmenate, Fatima Mohammed Alkaabi, Yandy Marx Castillo-Aleman, Carlos Agustin Villegas-Valverde, Yasmine Maher Ahmed, Pierdanilo Sanna, Ayesha Abdulla Almarzooqi, Abeer Abdelrazik, Gina Marcela Torres-Zambrano, Maura Wade-Mateo, David Quesada-Saliba, Loubna Abdel Hadi, Antonio Alfonso Bencomo-Hernandez, Rene Antonio Rivero-Jimenez
Formato:	article
Lenguaje:	EN
Publicado:	BMC 2021
Materias:	COVID-19 Stem cells Nebulizers and vaporizers Immunomodulation Recovery of function Medicine R
Acceso en línea:	https://doaj.org/article/36a3275ce2cd49b4b8623bc4859d89b2
Etiquetas:	Agregar Etiqueta Sin Etiquetas, Sea el primero en etiquetar este registro!

id	oai:doaj.org-article:36a3275ce2cd49b4b8623bc4859d89b2
record_format	dspace
spelling	oai:doaj.org-article:36a3275ce2cd49b4b8623bc4859d89b22021-11-08T11:18:17ZSafety and efficacy of autologous non-hematopoietic enriched stem cell nebulization in COVID-19 patients: a randomized clinical trial, Abu Dhabi 202010.1186/s41231-021-00101-52396-832Xhttps://doaj.org/article/36a3275ce2cd49b4b8623bc4859d89b22021-11-01T00:00:00Zhttps://doi.org/10.1186/s41231-021-00101-5https://doaj.org/toc/2396-832XAbstract Background The novel SARS-CoV-2 has caused the coronavirus disease 2019 (COVID-19) pandemic. Currently, with insufficient worldwide vaccination rates, identifying treatment solutions to reduce the impact of the virus is urgently needed. Method An adaptive, multicentric, open-label, and randomized controlled phase I/II clinical trial entitled the “SENTAD-COVID Study” was conducted by the Abu Dhabi Stem Cells Center under exceptional conditional approval by the Emirates Institutional Review Board (IRB) for COVID-19 Research Committee from April 4th to July 31st, 2020, using an autologous peripheral blood non-hematopoietic enriched stem cell cocktail (PB-NHESC-C) administered by compressor (jet) nebulization as a complement to standard care therapy. The primary endpoints include safety and efficacy assessments, adverse events, the mortality rate within 28 days, and the time to clinical improvement as measured by a 2-point reduction on a seven-category ordinal scale or discharge from the hospital whichever occurred first. Results The study included a total of 139 randomized COVID-19 patients, with 69 in the experimental group and 70 in the control group (standard care). Overall survival was 94.20% for the cocktail-treated group vs. 90.27% for the control group. Adverse events were reported in 50 (72.46%) patients receiving PB-NHESC-C and 51 (72.85%) in the control group (p = 0.9590), with signs and symptoms commonly found in COVID-19. After the first 9 days of the intervention, 67.3% of cocktail-treated patients recovered and were released from hospitals compared to 53.1% (RR = 0.84; 95% CI, 0.56–1.28) in the control group. Improvement, i.e., at least a 2-point reduction in the severity scale, was more frequently observed in cocktail-treated patients (42.0%) than in controls (17.0%) (RR = 0.69; 95% CI, 0.56–0.88). Conclusions Cocktail treatment improved clinical outcomes without increasing adverse events. Thus, the nebulization of PB-NHESC-C was safe and effective for treatment in most of these patients. Trial registration ClinicalTrials.gov. NCT04473170 . It was retrospectively registered on July 16th, 2020.Yendry Ventura-CarmenateFatima Mohammed AlkaabiYandy Marx Castillo-AlemanCarlos Agustin Villegas-ValverdeYasmine Maher AhmedPierdanilo SannaAyesha Abdulla AlmarzooqiAbeer AbdelrazikGina Marcela Torres-ZambranoMaura Wade-MateoDavid Quesada-SalibaLoubna Abdel HadiAntonio Alfonso Bencomo-HernandezRene Antonio Rivero-JimenezBMCarticleCOVID-19Stem cellsNebulizers and vaporizersImmunomodulationRecovery of functionMedicineRENTranslational Medicine Communications, Vol 6, Iss 1, Pp 1-18 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	COVID-19 Stem cells Nebulizers and vaporizers Immunomodulation Recovery of function Medicine R
spellingShingle	COVID-19 Stem cells Nebulizers and vaporizers Immunomodulation Recovery of function Medicine R Yendry Ventura-Carmenate Fatima Mohammed Alkaabi Yandy Marx Castillo-Aleman Carlos Agustin Villegas-Valverde Yasmine Maher Ahmed Pierdanilo Sanna Ayesha Abdulla Almarzooqi Abeer Abdelrazik Gina Marcela Torres-Zambrano Maura Wade-Mateo David Quesada-Saliba Loubna Abdel Hadi Antonio Alfonso Bencomo-Hernandez Rene Antonio Rivero-Jimenez Safety and efficacy of autologous non-hematopoietic enriched stem cell nebulization in COVID-19 patients: a randomized clinical trial, Abu Dhabi 2020
description	Abstract Background The novel SARS-CoV-2 has caused the coronavirus disease 2019 (COVID-19) pandemic. Currently, with insufficient worldwide vaccination rates, identifying treatment solutions to reduce the impact of the virus is urgently needed. Method An adaptive, multicentric, open-label, and randomized controlled phase I/II clinical trial entitled the “SENTAD-COVID Study” was conducted by the Abu Dhabi Stem Cells Center under exceptional conditional approval by the Emirates Institutional Review Board (IRB) for COVID-19 Research Committee from April 4th to July 31st, 2020, using an autologous peripheral blood non-hematopoietic enriched stem cell cocktail (PB-NHESC-C) administered by compressor (jet) nebulization as a complement to standard care therapy. The primary endpoints include safety and efficacy assessments, adverse events, the mortality rate within 28 days, and the time to clinical improvement as measured by a 2-point reduction on a seven-category ordinal scale or discharge from the hospital whichever occurred first. Results The study included a total of 139 randomized COVID-19 patients, with 69 in the experimental group and 70 in the control group (standard care). Overall survival was 94.20% for the cocktail-treated group vs. 90.27% for the control group. Adverse events were reported in 50 (72.46%) patients receiving PB-NHESC-C and 51 (72.85%) in the control group (p = 0.9590), with signs and symptoms commonly found in COVID-19. After the first 9 days of the intervention, 67.3% of cocktail-treated patients recovered and were released from hospitals compared to 53.1% (RR = 0.84; 95% CI, 0.56–1.28) in the control group. Improvement, i.e., at least a 2-point reduction in the severity scale, was more frequently observed in cocktail-treated patients (42.0%) than in controls (17.0%) (RR = 0.69; 95% CI, 0.56–0.88). Conclusions Cocktail treatment improved clinical outcomes without increasing adverse events. Thus, the nebulization of PB-NHESC-C was safe and effective for treatment in most of these patients. Trial registration ClinicalTrials.gov. NCT04473170 . It was retrospectively registered on July 16th, 2020.
format	article
author	Yendry Ventura-Carmenate Fatima Mohammed Alkaabi Yandy Marx Castillo-Aleman Carlos Agustin Villegas-Valverde Yasmine Maher Ahmed Pierdanilo Sanna Ayesha Abdulla Almarzooqi Abeer Abdelrazik Gina Marcela Torres-Zambrano Maura Wade-Mateo David Quesada-Saliba Loubna Abdel Hadi Antonio Alfonso Bencomo-Hernandez Rene Antonio Rivero-Jimenez
author_facet	Yendry Ventura-Carmenate Fatima Mohammed Alkaabi Yandy Marx Castillo-Aleman Carlos Agustin Villegas-Valverde Yasmine Maher Ahmed Pierdanilo Sanna Ayesha Abdulla Almarzooqi Abeer Abdelrazik Gina Marcela Torres-Zambrano Maura Wade-Mateo David Quesada-Saliba Loubna Abdel Hadi Antonio Alfonso Bencomo-Hernandez Rene Antonio Rivero-Jimenez
author_sort	Yendry Ventura-Carmenate
title	Safety and efficacy of autologous non-hematopoietic enriched stem cell nebulization in COVID-19 patients: a randomized clinical trial, Abu Dhabi 2020
title_short	Safety and efficacy of autologous non-hematopoietic enriched stem cell nebulization in COVID-19 patients: a randomized clinical trial, Abu Dhabi 2020
title_full	Safety and efficacy of autologous non-hematopoietic enriched stem cell nebulization in COVID-19 patients: a randomized clinical trial, Abu Dhabi 2020
title_fullStr	Safety and efficacy of autologous non-hematopoietic enriched stem cell nebulization in COVID-19 patients: a randomized clinical trial, Abu Dhabi 2020
title_full_unstemmed	Safety and efficacy of autologous non-hematopoietic enriched stem cell nebulization in COVID-19 patients: a randomized clinical trial, Abu Dhabi 2020
title_sort	safety and efficacy of autologous non-hematopoietic enriched stem cell nebulization in covid-19 patients: a randomized clinical trial, abu dhabi 2020
publisher	BMC
publishDate	2021
url	https://doaj.org/article/36a3275ce2cd49b4b8623bc4859d89b2
work_keys_str_mv	AT yendryventuracarmenate safetyandefficacyofautologousnonhematopoieticenrichedstemcellnebulizationincovid19patientsarandomizedclinicaltrialabudhabi2020 AT fatimamohammedalkaabi safetyandefficacyofautologousnonhematopoieticenrichedstemcellnebulizationincovid19patientsarandomizedclinicaltrialabudhabi2020 AT yandymarxcastilloaleman safetyandefficacyofautologousnonhematopoieticenrichedstemcellnebulizationincovid19patientsarandomizedclinicaltrialabudhabi2020 AT carlosagustinvillegasvalverde safetyandefficacyofautologousnonhematopoieticenrichedstemcellnebulizationincovid19patientsarandomizedclinicaltrialabudhabi2020 AT yasminemaherahmed safetyandefficacyofautologousnonhematopoieticenrichedstemcellnebulizationincovid19patientsarandomizedclinicaltrialabudhabi2020 AT pierdanilosanna safetyandefficacyofautologousnonhematopoieticenrichedstemcellnebulizationincovid19patientsarandomizedclinicaltrialabudhabi2020 AT ayeshaabdullaalmarzooqi safetyandefficacyofautologousnonhematopoieticenrichedstemcellnebulizationincovid19patientsarandomizedclinicaltrialabudhabi2020 AT abeerabdelrazik safetyandefficacyofautologousnonhematopoieticenrichedstemcellnebulizationincovid19patientsarandomizedclinicaltrialabudhabi2020 AT ginamarcelatorreszambrano safetyandefficacyofautologousnonhematopoieticenrichedstemcellnebulizationincovid19patientsarandomizedclinicaltrialabudhabi2020 AT maurawademateo safetyandefficacyofautologousnonhematopoieticenrichedstemcellnebulizationincovid19patientsarandomizedclinicaltrialabudhabi2020 AT davidquesadasaliba safetyandefficacyofautologousnonhematopoieticenrichedstemcellnebulizationincovid19patientsarandomizedclinicaltrialabudhabi2020 AT loubnaabdelhadi safetyandefficacyofautologousnonhematopoieticenrichedstemcellnebulizationincovid19patientsarandomizedclinicaltrialabudhabi2020 AT antonioalfonsobencomohernandez safetyandefficacyofautologousnonhematopoieticenrichedstemcellnebulizationincovid19patientsarandomizedclinicaltrialabudhabi2020 AT reneantonioriverojimenez safetyandefficacyofautologousnonhematopoieticenrichedstemcellnebulizationincovid19patientsarandomizedclinicaltrialabudhabi2020
_version_	1718442224174235648

Safety and efficacy of autologous non-hematopoietic enriched stem cell nebulization in COVID-19 patients: a randomized clinical trial, Abu Dhabi 2020

Ejemplares similares