The Canadian ProTrans in COVID-19 single center trial is expanded to a multicenter trial

NextCell Pharma AB (“NextCell”) today announces that the clinical trial ProTrans19+CA expanded to include an additional site: the Jewish General Hospital in Montreal, Canada.  The hospital is one of the largest in Canada and is affiliated with the trial Sponsor, the Research Institute of McGill University Health Center. Patient enrolment increased due to the omicron variant, which we envisage will be further enhanced by patient reqruitment at both sites, the Royal Victoria and Jewish General Hospital.

The coronavirus pandemic has transformed over time and omicron has shown to be more contagious but associated with milder symptoms, especially for the growing proportion of vaccinated people. The number of cases were relatively low in Canada but as everywhere else, increased drastically in late 2021. ProTrans19+CA started to enroll patients in mid 2021 and 14 of the 48 patients have been treated with ProTrans to date.

“We are very happy to join forces with our collegues at the Jewish. Enrolment increased during winter and we expect  to leverage that with another hospital”, says Dr. Inés Colmegna Associate Professor at McGill University and Principal Investigator of the trial.

ProTrans19+CA

The clinical trial full title is “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 aims to 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 the RI-MUHC and JGH both in 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, co-PI and Doctor Emily MacDonald, MUHC, co-PI Professor Dr Marie Hudson and Professor Dr Andrew Hirsch, Jewish General Hospital and McGill University and Doctor Lindsay Davies, CSO NextCell Pharma & Karolinska Institutet.

For further information, please contact:
Mathias Svahn, CEO
Patrik Fagerholm, CFO
Tel: +46 8 735 5595
E-mail: info@nextcellpharma.com

Websites:
NextCell Pharma AB: www.nextcellpharma.com
Cellaviva Sverige: www.cellaviva.se
Cellaviva Danmark: www.cellaviva.dk

LinkedIn: https://www.linkedin.com/company/15255207/
Twitter: https://twitter.com/NextCellPharma

About NextCell Pharma AB

NextCell is a phase II cell therapy company with the drug candidate ProTrans for the treatment of type 1 diabetes. The focus is to take ProTrans to market approval via a Phase III study. ProTrans is in addition to diabetes, used in two clinical trials for Covid-19, in Örebro and Montreal (Canada). The company is in the processes of establishing its own GMP facility for production of ProTrans. The GMP facility is expected to be ready for production of smaller quantities of ProTrans in 2023. NextCell furthermore owns 8,5% in FamicordTX, a CAR-T start-up in oncology and 100 % of Cellaviva, Scandinavia's largest stem cell bank for family saving stem cells from umbilical cord blood and umbilical cord tissue with permission from the Swedish Health and Social Care Inspectorate (IVO).

FNCA Sweden AB is assigned as Certified Adviser, 08-528 00 399, info@fnca.se.