All Patients with Severe Virus-Induced Pneumonia Treated in the ProTrans V Study

ProTrans V (formerly known as ProTrans19+SE) is an open-label dose-escalation study (Phase 1) in which adult patients suffering from severe pneumonia due to viral infection are treated with ProTrans. Treatment with all evaluated doses—low, medium, and high—has demonstrated a strong safety profile. The study initially focused on patients with SARS-CoV-2 infection, but was expanded to include patients with Influenza A, Respiratory Syncytial Virus (RSV), and Human Metapneumovirus.

"The fact that we have now treated all patients in the study is an important milestone. We look forward to analysing the results and continuing our work to develop ProTrans as a safe and effective treatment for patients with severe inflammatory conditions," says Mathias Svahn, CEO of NextCell Pharma.

The study is being conducted at Örebro University Hospital under the leadership of Principal Investigator Dr. Josefin Sundh, Associate Professor and Senior Consultant at the Pulmonary Section, Heart-Lung Physiological Clinic, and University Lecturer at the Department of Medical Sciences, Örebro University.

The full study title is: "Treatment of Respiratory Complications Associated with COVID-19, Influenza A, Metapneumovirus, Respiratory Syncytial Virus (RSV) Infection Using Wharton's Jelly (WJ)-Umbilical Cord (UC) Mesenchymal Stromal Cells (ProTrans®): open Phase IB Clinical Trial" (EudraCT 2020-002078-29). NextCell is the Sponsor of the study, which includes nine patients with severe pneumonia caused by confirmed viral infection, who are treated with a low (3 patients), medium (3 patients), or high dose (3 patients) of ProTrans. The study is registered on clinicaltrials.gov, identity number NCT04896853.

NextCell has developed the drug candidate ProTrans, a cell therapy for the treatment of autoimmune diseases and inflammatory conditions. ProTrans is a platform technology with broad potential and application. NextCell has previously conducted several clinical studies with the cell therapy, including ProTrans-1, ProTrans-2, and the ongoing ProTrans-Young, which evaluates the treatment's safety and efficacy in type 1 diabetes, where the drug product has shown promising results in preserving the patient’s own insulin production. ProTrans is based on the expansion and formulation of carefully selected umbilical cord stromal cells, optimized to suppress an overactive immune system and restore immune balance.

The safe application of ProTrans in the treatment of severe pneumonia associated with viral infection demonstrates the scope of clinical application for the cell therapy. Infectious disease and the inflammatory complications thereof are a newer area for mesenchymal stromal cell therapy, where NextCell sees the potential for further development of their ProTrans product.

"We see a great need for innovative treatments for severe inflammatory conditions. The results of this study will contribute to our understanding of how ProTrans can be used to manage these diseases and provide patients with new treatment options," concludes Mathias Svahn.