The Data and Safety Monitoring Board approves the usage of high-dose ProTrans in the ongoing clinical trial
Stem cell company NextCell Pharma AB ("NXTCL") announces today that the Data and Safety Monitoring Board for the clinical trial using ProTrans has given its approval for the principal investigator professor Per-Ola Carlsson and NextCell to proceed and treat 3 patients in the high-dose cohort.
The treatment of all three patients in the medium-dose cohort with ProTrans has been assessed as safe using a one-month follow-up period. Now NXTCL is now able to recruit patients for the last dose cohort, which is the high-dose cohort. The recruitment of the last dose cohort is expected to take one month longer than the other dose cohorts because of summer vacations.
The high-dose cohort is the last cohort in the first part of the study. The second part of the study is randomized, double-blind and placebo-controlled, where 10 ten patients receive active treatment and 5 five patients receive placebo. Patients will then be followed for 12 months.
The Data and Safety Monitoring Boards consists of; 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, Skåne University Hospital, Lund University.
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 29th of June 2018.
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