The full title of the study is: "Treatment of Respiratory Complications Associated with COVID-19 Infection with Wharton's Jelly (WJ) -Umbilical Cord (UC) Mesenchymal Stromal Cells (ProTrans®): An Open Phase IB Clinical Trial", (EudraCT 2020-002078-29). NextCell sponsors the study, which will include a total of nine patients with severe pneumonia and confirmed COVID-19 (SARS-CoV-2) infection, who are treated with a low (three patients) medium (three patients) or high dose (three patients) of ProTrans.

Patients in the low-dose group will now be followed for 1 month, after which the study’s Data Safety Monitoring Board will review the patient data and provide a recommendation on whether to continue with recruitment and treatment of the next dose cohort. The Data Safety Monitoring Board consists of Chairman Associate Professor Peter Bergman, Karolinska University Hospital, Karolinska Institutet and Professor Åke Lernmark, Skåne University Hospital, Lund University and Dr Magnus Didner Nisell, Karolinska University Hospital, Karolinska Institutet. The Board’s advice is advisory, with the Sponsor's responsibility to make the decision to proceed.

The Principle Investigator for ProTrans19+SE is Associate Professor Josefin Sundh and the study is conducted in collaboration with the Division of Clinical Trials (AKP), University Hospital Örebro and Karolinska Trial Alliance (KTA). The study is registered on clinicaltrials.gov with the number NCT04896853.

NextCell also provides ProTrans to the Canadian COVID-19 study, ProTrans19+CA sponsored by McGill University in Montreal. The study is ongoing and is registered on clinicaltrials.gov with the number NCT04869397. The full title is:  "Treatment of respiratory complications associated with COVID-19 infection with Wharton's Jelly (WJ) -Umbilical Cord (UC)) Mesenchymal strom cells (ProTrans ™): a randomized Phase II clinical trial". Sponsor of the study is the Research Institute of the McGill University Health Centre. The study will include 48 patients with severe pneumonia and confirmed COVID-19 (SARS-CoV-2) infection, who are randomized to ProTrans treatment (24 patients) or placebo (24 patients).