ProTrans Observation Study for long term efficacy in diabetes
NextCell Pharma AB (“NextCell” or “the Company”) today announces that an observational study, ProTrans-OBS, has been approved by the Swedish Ethical Review Board for long-term follow-up of patients previously participating in the ProTrans-2 clinical trial. The study is conducted by professor Per-Ola Carlsson, at Uppsala University.
The observational study, ProTrans-OBS, is a non-interventional study, i.e. patients will not be treated with additional doses of ProTrans. Participants that completed the ProTrans-2 trial will be asked for informed consent for biannual clinical assessment of safety and efficacy for a posttrial period of 4 years.
As reported, the ProTrans-Repeat study showed sustained effect and safety over 2 years, where an additional high dose ProTrans was administered after 12 months. The long-term effect of single infusion in comparison to two infusions will be evaluated by running both ProTrans-Repeat and ProTrans-OBS in parallel. The costs related to the OBS study are included in the existing budget.
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 below contact person for publication on 15th of December 2020.
Stay up to date with the latest development in NextCell Pharma
LinkedIn: https://www.linkedin.com/company/15255207/
Twitter: https://twitter.com/NextCellPharma
For more information about NextCell Pharma AB, please contact:
Mathias Svahn, CEO
Sofia Fredrikson, CFO
Phone: 08-735 5595
E-mail: info@nextcellpharma.com
Website:
www.nextcellpharma.com, www.cellaviva.se
www.cellaviva.dk
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, info@fnca.se.