The Data and Safety Monitoring Board approves the usage of medium-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 medium-dose cohort.
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.
The treatment with ProTrans of all three patients in the low-dose cohort has been assessed as safe after one-month follow-up. Likewise, patients in the medium-dose cohort will be assessed before recruitment to the high-dose cohort can be initiated. Once one-month follow-up of the high-dose cohort has been evaluated for safety, the randomized, double-blind, placebo-controlled part of the study can be initiated with a total of 15 additional patients.
“Treatment with ProTrans is expected to only show mild and transient side effects, as shown in the low-dose cohort”, says Mathias Svahn, CEO
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 March 27th, 2018.
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For more information about NextCell Pharma AB, please contact:
Mathias Svahn, CEO
Leo Groenewegen, CFO
Phone: 08-735 5595
About NextCell Pharma AB:
Stem cells are expected to change the way how many of today's life-threatening diseases are treated. NextCellPharma AB develops ProTrans™, a drug candidate consisting of stem cells for the primary treatment of autoimmuneand inflammatory diseases as well as for use in kidney transplants. ProTrans™ consists of selected stem cells derived from the umbilical cord tissue with NextCell Pharma AB's proprietary method. In addition, the company has 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.