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

• Published in: Translational medicine communications 2021-01, Vol.6 (1), p.25-25, Article 25
• Main Authors: Ventura-Carmenate, Yendry, Alkaabi, Fatima Mohammed, Castillo-Aleman, Yandy Marx, Villegas-Valverde, Carlos Agustin, Ahmed, Yasmine Maher, Sanna, Pierdanilo, Almarzooqi, Ayesha Abdulla, Abdelrazik, Abeer, Torres-Zambrano, Gina Marcela, Wade-Mateo, Maura, Quesada-Saliba, David, Abdel Hadi, Loubna, Bencomo-Hernandez, Antonio Alfonso, Rivero-Jimenez, Rene Antonio
• Format: Article
• Language: English
• Subjects: Blood platelets; Clinical trials; Cloning; Coronaviruses; COVID-19; Disease; Flow cytometry; Hospitalization; Hospitals; Immune system; Immunomodulation; Infections; Informed consent; Nebulizers and vaporizers; Patients; Recovery of function; Severe acute respiratory syndrome coronavirus 2; Stem cells; Ventilation
• ISSN: 2396-832X; 2396-832X
• DOI: 10.1186/s41231-021-00101-5

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. An adaptive, multicentric, open-label, and randomized controlled phase I/II clinical trial entitled the "SENTAD-COVID Study" was conducted by the 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. 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 (  = 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). 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. ClinicalTrials.gov. NCT04473170. It was retrospectively registered on July 16th, 2020.