Study start for ProTrans in COVID-19
NextCell Pharma AB (“NextCell”) announces today that both the Canadian and Swedish COVID-19 studies have been initiated and are now ready to include patients with severe pneumonia triggered by SARS-CoV-2 infection. The treatment is aimed at patients who are hospitalized and with a high risk of needing ventilatory support. ProTrans is given as a peripheral infusion. With the aim of reducing hyper-inflammation within the lungs. The goal of the treatment is to shorten hospital stay and time for rehabilitation, and to save lives.
- ProTrans19 + CA, a randomized placebo-controlled phase-II study in Canada with a total of 48 patients
- ProTrans19 + SE, an open dose escalation phase Ib study in Sweden with a total of 9 patients
- Both studies are now ready to enrol
The clinical trial protocols for both the studies have been written by Professor Dominique Farge and Doctor Lindsay Davies, CSO NextCell Pharma. Some national adjustments have been made in consultation with the Principal Investigators Professor Josefin Sundh in Sweden and Associate Professor Inés Colmegna in Canada to allow cross-comparison between data sets from both studies. The Swedish trial is a phase-Ib dose escalation study, with a total of 9 patients, and a primary endpoint to evaluate safety. The Canadian trial is a phase-II study and will enrol 48 patients, randomized for treatment with ProTrans or placebo. Primary endpoint is to evaluate the efficacy of ProTrans treatment.
“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 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 trial is an international collaboration between McGill University, Montreal Canada; NextCell Pharma AB, Stockholm Sweden; Saint-Louis Hospital, Paris University, 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, co-PI Doctor Emily McDonald, McGill University and Doctor Lindsay Davies, CSO NextCell Pharma & Karolinska Institutet.
ProTrans19+SE, (EudrCT 2020-002078-29)
“Treatment of Respiratory Complications Associated with COVID-19 Infection Using Wharton’s Jelly - Umbilical Cord Mesenchymal Stromal Cells (ProTrans®): Open Phase IB Clinical Trial” NextCell sponsors the study, which will include 9 patients with severe pneumonia and confirmed COVID-19 (SARS-CoV-2) infection, who will be treated with low (3 patients), medium (3 patients), or high dose (3 patients) ProTrans.
The study will be performed at the University Hospital in Örebro in collaboration with the Department of Clinical Trials and Karolinska Trial Alliance. The Principal Investigator in Sweden is Professor Josefin Sundh.
Stay up to date with the latest development in NextCell Pharma
For more information about NextCell Pharma AB, please contact:
Mathias Svahn, CEO
Sofia Fredrikson, CFO
Phone: 08-735 5595
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.
FNCA Sweden AB is assigned as Certified Adviser, 08-528 00 399, firstname.lastname@example.org.