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
{"title":"自体非造血富集干细胞雾化治疗COVID-19患者的安全性和有效性:一项随机临床试验，Abu Dhabi 2020。","authors":"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","doi":"10.1186/s41231-021-00101-5","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>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.</p><p><strong>Method: </strong>An adaptive, multicentric, open-label, and randomized controlled phase I/II clinical trial entitled the \"SENTAD-COVID Study\" was conducted by the <i>Abu Dhabi Stem Cells Center</i> 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.</p><p><strong>Results: </strong>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 (<i>p</i> = 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).</p><p><strong>Conclusions: </strong>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.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov. NCT04473170. It was retrospectively registered on July 16th, 2020.</p>","PeriodicalId":75244,"journal":{"name":"Translational medicine communications","volume":"6 1","pages":"25"},"PeriodicalIF":0.0000,"publicationDate":"2021-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8563822/pdf/","citationCount":"5","resultStr":"{\"title\":\"Safety and efficacy of autologous non-hematopoietic enriched stem cell nebulization in COVID-19 patients: a randomized clinical trial, Abu Dhabi 2020.\",\"authors\":\"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\",\"doi\":\"10.1186/s41231-021-00101-5\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>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.</p><p><strong>Method: </strong>An adaptive, multicentric, open-label, and randomized controlled phase I/II clinical trial entitled the \\\"SENTAD-COVID Study\\\" was conducted by the <i>Abu Dhabi Stem Cells Center</i> 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.</p><p><strong>Results: </strong>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 (<i>p</i> = 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).</p><p><strong>Conclusions: </strong>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.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov. NCT04473170. It was retrospectively registered on July 16th, 2020.</p>\",\"PeriodicalId\":75244,\"journal\":{\"name\":\"Translational medicine communications\",\"volume\":\"6 1\",\"pages\":\"25\"},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2021-01-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8563822/pdf/\",\"citationCount\":\"5\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Translational medicine communications\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.1186/s41231-021-00101-5\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"\",\"JCRName\":\"\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Translational medicine communications","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.1186/s41231-021-00101-5","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
Safety and efficacy of autologous non-hematopoietic enriched stem cell nebulization in COVID-19 patients: a randomized clinical trial, Abu Dhabi 2020.
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.
求助内容：
应助结果提醒方式：
京公网安备 11010802042870号
