NextCell Pharma AB (“NextCell”) today announces that Health Canada and the McGill University Health Centre Research Ethics Board have authorized the clinical trial entitled “Treatment of Respiratory Complications Associated with COVID-19 Infection Using Wharton’s Jelly (WJ)-Umbilical Cord (UC) Mesenchymal Stromal Cells (ProTrans™): a Randomized Phase II Controlled Clinical Trial”. The sponsor for this trial is the Research Institute of the McGill University Health Centre. The trial will enrol 48 patients with severe pneumonia associated with confirmed COVID-19 (SARS-CoV-2) infection, randomised to ProTrans treatment (24 patients) or placebo (24 patients).
The coronavirus pandemic may unfortunately be far from over. Mesenchymal stromal cell therapies have shown promise in the treatment of acute respiratory distress syndrome (ARDS), pneumonia, inflammation, and sepsis, which are among the leading causes of mortality in COVID-19 patients. The ProTrans study has been designed to evaluate whether it is possible to protect patients from developing ARDS by intervening early and breaking disease progression upon the onset of pneumonia. ProTrans is different from other MSC products in that it is developed from umbilical cords selected with a proprietary algorithm (patent pending).
“We are excited to lead this trial, which will be the first investigation of MSC therapy for COVID-19 treatment at McGill. We believe there is real potential for MSCs to dampen the damaging inflammatory response that leads to life-threatening disease”, says Dr. James Martin Senior Scientist at the Research Institute of the McGill University Health Centre and Professor at McGill University and a member of the trial team.
The trial is an international collaboration between McGill University, Montreal Canada; NextCell Pharma AB, Stockholm Sweden; Saint-Louis Hospital, Paris, France, and FamiCord Group PBKM SA, Warsaw, Poland. The core trial team designing the study are Principal Investigator Associate Professor Inés Colmegna, McGill University, co-PI Professor Dominique Farge, MATHEC, Center of Reference FAI2R, Hôpital St-Louis, IRSL, Université de Paris & adjunct Professor McGill University, co-PI Professor James Martin, McGill University, co-PI Doctor Ilan Azuelos, McGill University, and Doctor Lindsay Davies, CSO NextCell Pharma & Karolinska Institutet.
“The opportunity to conduct such a stringent trial for COVID-19 provides a key opportunity to significantly help patients, while learning about COVID-19 and how MSC therapy can halt its progression”, says Dr. Lindsay Davies, CSO NextCell Pharma & Karolinska Institutet.
NextCell Pharma will provide ProTrans to the Canadian trial site and has participated in the trial design. NextCell has successfully completed clinical trials using ProTrans for the treatment of a chronic autoimmune disease, type-I diabetes. This trial will use the same immunomodulatory capacity of ProTrans, but for treating an acute and potentially fatal viral infection.
“It is of course a privilege for NextCell, that its candidate stromal cell product, ProTrans, has been selected to be evaluated as a treatment for COVID-19. It is an unprecendented opportunity for us to take on this fight together with world leading experts”, says CEO Mathias Svahn.
This is the information that NextCell Pharma AB is required to disclose under the EU Market Abuse Regulation. The information was provided by the below contact person for publication on 2nd of February 2021.
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About NextCell Pharma AB
NextCell is a Phase II cell therapy company with the lead candidate ProTrans™, for the treatment of type-1 diabetes. Focus is to take ProTrans™ to market approval via a phase III study. Furthermore, NextCell operates Cellaviva, Scandinavia’s largest stem cell bank for family-saving of stem cells from umbilical cord blood and umbilical cord tissue with permission from IVO.
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