NextCell Pharma AB submits clinical trial application for its drug candidate ProTrans™
NextCell Pharma AB ("NextCell") announced today that a clinical trial application for ProTrans™, a stem cell product developed with NextCell's Proprietary Selection Algorithm, has been submitted to the Medical Products Agency (Läkemedelsverket). The study is planned to evaluate the safety and efficacy of ProTrans™ in adult patients with type 1 diabetes diagnosed within two years.
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.
Professor Carlsson is a leading physician and researcher in the field of diabetes and has previously been the principal investigator for a similar study where autologous stem cells was used for the treatment of type 1 diabetes.
- Stem cells extracted from the umbilical cord have a very interesting biology and moreover, the availability is great, says professor Carlsson.
- ProTrans is a so-called Advanced Therapy Medicinal Product consisting of stem cells developed with NextCell's Proprietary Selection Algorithm, says Mathias Svahn, CEO of NextCell. - The application submission is an important milestone for us and we are excited to have a strong study team on-board for this potentially ground breaking study.
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 July 24, 2017.
For more information about NextCell Pharma AB, please contact:
Mathias Svahn, CEO
Phone: 0702-615 504
About NextCell Pharma AB:
Stem cells are expected to change the way how many of today's life-threatening diseases are treated. NextCell Pharma AB develops ProTrans™, a drug candidate consisting of stem cells, primarily for the treatment of autoimmune and inflammatory diseases as well as for use at kidney transplantations. ProTrans™ consists of stem cells derived from the umbilical cord tissue with NextCell Pharma AB's proprietary Selection Algorithm. In addition, the company provides a service called Cellaviva, Sweden's first and only IVO-approved stem cell bank for the family-saving of stem cells from umbilical cord blood and umbilical cord tissue.