Abstract 7 2023 Update: Development of COVID-19 Therapies from Birthing Tissues and Cord Blood

INTRODUCTION: The Coronavirus pandemic presents a fleeting opportunity to evaluate the safety and efficacy of advanced cell therapy products, such as Mesenchymal Stromal Cells (MSCs), against a virus that attacks multiple organs and causes respiratory distress. With the pandemic winding down, there is a limited amount of clinical data to analyze. OBJECTIVES: We ask whether perinatal sources of cells have played a significant role in clinical applications of cell therapy for COVID-19? METHODS: We are the only research group that is performing worldwide tracking of both clinical trials of advanced cell therapy for COVID-19 as well as the reported outcomes of those trials. Our methods were published in Couto et al. 2023 DOI:10.3389/fimmu.2023.1200180/ RESULTS: We identified 207 advanced cell therapy trials for COVID-19 through the end of 2022, where 41% employed perinatal cells (sometimes multiple types). We also identified publications from those trials through April 2023, finding 43, where 25 employ perinatal MSCs, 10 employ MSCs from other sources, and 8 are cellular immunotherapy (3 of them from perinatal sources). Thus far, 65% of the published trial outcomes rely on cells of perinatal origin. There are also 8 publications reporting on cell therapy of two or more COVID-19 patients treated under compassionate use programs, where 5 employ perinatal MSCs, 2 employ MSCs from other sources, and 1 employed MSCs of unknown origin. Figure 1 displays a timeline of trials and publications by month. Thus far, numbers of trials surged once and peaked in April 2020, whereas published reports have been appearing at a steady average rate of 1.3 publications per month. DISCUSSION: Couto et al. 2023 was the most complete meta-analysis to date of the efficacy of intravenous MSC as a therapy for COVID-19. Combining 24 studies, they found a relative risk reduction for all-cause COVID-19 mortality of RR=0.63 [95% C.I. 0.46; 0.85]. They also found that for the 18 studies employing perinatal MSCs, RR=0.75 [95% C.I. 0.54; 1.02]. Figure 1 represents the first step towards a sequel study where we will repeat the meta-analysis of MSC benefit for COVID-19 mortality with a bigger data set. [Image: see text] This figure displays a monthly timeline of advanced cell therapy for COVID-19 in three categories: clinical trials registered worldwide, published outcomes of those clinical trials, and published reports from compassionate use programs that covered two or more patients. The trials data runs over the 36 months Jan. 2020 – Dec. 2022, whereas the publications data runs over the 40 months Jan. 2020 – April 2023.