NextCell Pharma AB ("NextCell" or the "Company") announces that the Phase II clinical trial evaluating ProTrans® (allogeneic Wharton's Jelly-derived mesenchymal stromal cells) for respiratory complications associated with COVID-19 has been accepted for publication in Cytotherapy, the official journal of the International Society for Cell & Gene Therapy.
The study, titled "Umbilical Cord Mesenchymal Stromal Cells for Respiratory Complications of COVID-19 Infection (ProTrans): Phase II Randomized Clinical Trial," reports results from ProTrans19+, a randomized, double-blind, placebo-controlled, multi-center Phase II study conducted in Canada.
The trial was investigator-initiated and sponsored by McGill University Health Centre (MUHC). NextCell supported the study by supplying ProTrans. Patients were recruited at two McGill University-affiliated hospitals in Montreal: The Royal Victoria Hospital and the Jewish General Hospital.
ProTrans19+ evaluated the safety and exploratory efficacy of a single intravenous infusion of ProTrans in hospitalized patients with severe COVID-19 pneumonia requiring oxygen support. The trial was discontinued early due to feasibility considerations in the context of evolving standards of care and reduced event rates during later stages of the pandemic.
The study confirms the short-term safety of ProTrans in hospitalized patients receiving contemporary standard-of-care therapies. Due to limited enrollment and early termination, no definitive conclusions regarding efficacy can be drawn.
"The publication underscores the robustness of the ProTrans manufacturing platform, and the potential for the drug's use in a growing number of inflammatory conditions. This trial has also demonstrated the importance of rigorous trial design when evaluating advanced therapies in rapidly changing clinical settings," said Lindsay Davies, PhD, Chief Scientific Officer of NextCell Pharma.
Lindsay Davies and CEO Mathias Svahn are co-authors of the publication.
Acceptance for publication in Cytotherapy reflects the scientific rigor of the study and contributes to the growing body of clinical evidence evaluating mesenchymal stromal cell therapies in inflammatory lung disease.
The publication is available via the link: https://www.isct-cytotherapy.org/article/S1465-3249(26)00736-X/abstract