There are no definitive therapies for patients with severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) infection. Therefore, new therapeutic strategies are needed to improve clinical outcomes, particularly in patients with severe disease. This case series explores the safety and effectiveness of intravenous allogeneic cardiosphere-derived cells (CDCs), formulated as CAP-1002, in critically ill patients with confirmed coronavirus disease 2019 (COVID-19). Adverse reactions to CAP-1002, clinical status on the World Health Organization (WHO) ordinal scale, and changes in pro-inflammatory biomarkers and leukocyte counts were analyzed. All patients ( n = 6; age range 19–75 years, 1 female) required ventilatory support (invasive mechanical ventilation, n = 5) with PaO 2 /FiO 2 ranging from 69 to 198. No adverse events related to CAP-1002 administration were observed. Four patients (67%) were weaned from respiratory support and discharged from the hospital. One patient remains mechanically ventilated as of April 28th, 2020; all survive. A contemporaneous control group of critically ill COVID-19 patients ( n = 34) at our institution showed 18% overall mortality at a similar stage of hospitalization. Ferritin was elevated in all patients at baseline (range of all patients 605.43–2991.52 ng/ml) and decreased in 5/6 patients (range of all patients 252.89–1029.90 ng/ml). Absolute lymphocyte counts were low in 5/6 patients at baseline (range 0.26–0.82 × 10 3 /µl) but had increased in three of these five patients at last follow-up (range 0.23–1.02 × 10 3 /µl). In this series of six critically ill COVID-19 patients, intravenous infusion of CAP-1002 was well tolerated and associated with resolution of critical illness in 4 patients. This series demonstrates the apparent safety of CAP-1002 in COVID-19. While this initial experience is promising, efficacy will need to be further assessed in a randomized controlled trial.
【저자키워드】 Cytokine storm, coronavirus, Cell therapy, hyperinflammation, 【초록키워드】 COVID-19, Randomized controlled trial, coronavirus disease, SARS-CoV-2, Efficacy, therapy, Hospitalization, hospital, Infection, clinical status, Lymphocyte count, Critically ill, adverse event, female, Patient, Effectiveness, age, Allogeneic, WHO, Follow-up, Critical, patients, cDCs, therapeutic strategy, COVID-19 patients, Coronavirus-2, Invasive mechanical ventilation, administration, severe disease, Respiratory Support, Adverse reaction, COVID-19 patient, intravenous, ventilatory support, leukocyte, World Health Organization, Critically ill patient, acute respiratory syndrome, control group, overall mortality, one patient, mechanically ventilated, while, FIVE, Cell, initial, analyzed, required, elevated, case sery, changes in, discharged, baseline, improve clinical outcomes, PaO, pro-inflammatory biomarker, 【제목키워드】 COVID-19, Critically ill, Cell, compassionate-use, case sery,