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, 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, 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
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.
Conflict of interest statement
Competing interestsThe procedure for obtaining the PB-NHESC-C mentioned in this report was advanced through research conducted and patented for ADSCC by YVC, AABH, and FMA. We declare that YMCA, CAVV, PS, YMA, AA, LAH, GMTZ, and RARJ are also staff members of ADSCC. For the rest thereof the co-authors, there are no competing interests. In May 2020, the patented procedure was approved by the Ministry of Economy of the United Arab Emirates, and also in May 2020, 5 of the authors (FMA, YVC, RARJ, AABH, and YMCA) received 3 Copyrights from the INTEROCO Copyright Office (EC-01-002809, EC-01-002810, and EC-01-002811), so this procedure including nebulization has been accredited to ADSCC. Nevertheless, YVC and the other patent authors resigned to be eligible to receive equity due to the licensing of this procedure.
© The Author(s) 2021.
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