NextCell Pharma AB receives approval from Ethics Committee for Clinical Trial
NextCell Pharma AB (NEXTCL) announced today that the clinical trial application for ProTrans™ has been granted by the Ehtics Committee. ProTrans™ is a stem cell product developed with NextCell's Proprietary Selection Algorithm. The clinical trial is designed to evaluate the safety and efficacy of ProTrans™ for treatment of patients with type 1 diabetes.
The study sponsor is NextCell and the principal investigator is Professor Per-Ola Carlsson, who works at Uppsala University and the Academic Hospital in Uppsala. The study will be conducted together with Karolinska Trial Alliance (KTA), which holds great expertise in performing cell therapy clinical trials. Treatments are scheduled to take place at the KTA Phase I unit located at Karolinska University Hospital in Huddinge. Ulf Smith MD, PhD, Professor and Director, Lundberg Laboratory for Diabetes Research, Sahlgrenska Academy and Sahlgrenska University Hospital, Gothenburg; Anders Fasth MD, PhD, Professor of Pediatric Immunology, Sahlgrenska Academy and Chief Physician at Drottning Silvias Children's Hospital, University of Gothenburg; and Åke Lernmark PhD, Professor and Principal Investigator in Diabetes and Coeliac, MAS, Lund University; will together make up the Data Safety Monitoring Board with Ulf Smith as Chairman.
We hope to start the clinical trial soon after approval by the Swedish Medical Products Agency, says Mathias Svahn, CEO of NextCell. The application was registered with the Medical Products Agency on July 24th and feedback is expected to be received within the next few weeks. Receiving approval from an ethical point of view is an important first step.
For more information about NextCell Pharma AB, please contact:
Mathias Svahn, CEO
Phone: 0702-615 504
This information is the information that NextCell Pharma AB is required to disclose under the EU Market Abuse
Regulation. The information was provided by the above contact person for publication on September 5, 2017.