tetano
Editor, Senior Moderator
Transl Med Commun
. 2021;6(1):25.
doi: 10.1186/s41231-021-00101-5. Epub 2021 Nov 3.
Safety and efficacy of autologous non-hematopoietic enriched stem cell nebulization in COVID-19 patients: a randomized clinical trial, Abu Dhabi 2020
Yendry Ventura-Carmenate[SUP] 1 [/SUP], Fatima Mohammed Alkaabi[SUP] 2 [/SUP], Yandy Marx Castillo-Aleman[SUP] 1 [/SUP], Carlos Agustin Villegas-Valverde[SUP] 1 [/SUP], Yasmine Maher Ahmed[SUP] 1 [/SUP], Pierdanilo Sanna[SUP] 1 [/SUP], Ayesha Abdulla Almarzooqi[SUP] 2 [/SUP], Abeer Abdelrazik[SUP] 1 [/SUP], Gina Marcela Torres-Zambrano[SUP] 1 [/SUP], Maura Wade-Mateo[SUP] 3 [/SUP], David Quesada-Saliba[SUP] 4 [/SUP], Loubna Abdel Hadi[SUP] 1 [/SUP], Antonio Alfonso Bencomo-Hernandez[SUP] 1 [/SUP], Rene Antonio Rivero-Jimenez[SUP] 1 [/SUP]
Affiliations
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.
Keywords: COVID-19; Immunomodulation; Nebulizers and vaporizers; Recovery of function; Stem cells.
. 2021;6(1):25.
doi: 10.1186/s41231-021-00101-5. Epub 2021 Nov 3.
Safety and efficacy of autologous non-hematopoietic enriched stem cell nebulization in COVID-19 patients: a randomized clinical trial, Abu Dhabi 2020
Yendry Ventura-Carmenate[SUP] 1 [/SUP], Fatima Mohammed Alkaabi[SUP] 2 [/SUP], Yandy Marx Castillo-Aleman[SUP] 1 [/SUP], Carlos Agustin Villegas-Valverde[SUP] 1 [/SUP], Yasmine Maher Ahmed[SUP] 1 [/SUP], Pierdanilo Sanna[SUP] 1 [/SUP], Ayesha Abdulla Almarzooqi[SUP] 2 [/SUP], Abeer Abdelrazik[SUP] 1 [/SUP], Gina Marcela Torres-Zambrano[SUP] 1 [/SUP], Maura Wade-Mateo[SUP] 3 [/SUP], David Quesada-Saliba[SUP] 4 [/SUP], Loubna Abdel Hadi[SUP] 1 [/SUP], Antonio Alfonso Bencomo-Hernandez[SUP] 1 [/SUP], Rene Antonio Rivero-Jimenez[SUP] 1 [/SUP]
Affiliations
- PMID: 34746417
- PMCID: PMC8563822
- DOI: 10.1186/s41231-021-00101-5
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.
Keywords: COVID-19; Immunomodulation; Nebulizers and vaporizers; Recovery of function; Stem cells.