Evaluating therapeutic potential of integrin 10-selected MSCs in treatment of COVID-19 (ARDS)

Purpose and goal The project is a collaboration between Xintela AB in Lund and Skåne University Hospital in Lund (SUS) and aims to demonstrate safety and efficacy of Xintela's selected MSCs in a relevant porcine model for COVID-19 ARDS (Acute Respiratory Distress Syndrome). The goal is to provide important preclinical information for the safe and effective use of the MSCs in treatment of COVID-19 ARDS patients. With the results from the project Xintela can apply for permission to start the first in human clinical study. Expected results and effects The preclinical study described in this project provide an accelerated way to demonstrate the potential of Xintela's MSCs for treatment of COVID-19 ARDS. The treatment has the potential to shorten and resolve the ARDS reaction seen in high numbers of COVID-19 victims admitted to Intensive Care Units (ICU) with breathing difficulties. The results from the study will be jointly published in a scientific journal by SUS and Xintela. The data generated will be used to make an application to begin human clinical trials. Planned approach and implementation The feasibility of the project is high. The method and routines for manufacturing of the MSC´s at Xintelas GMP-prepared lab is robust, reproducible and well established. This is also valid for the porcine study model from Skåne University Hospital. The model is well described, used for several studies before and published in several scientific journals. The project will be conducted in three phases: 1. Manufacturing of MSCs (6 weeks); 2. Preclinical animal study (3 weeks); 3. Analysis of plasma and tissue samples (2 month).