Six patients now treated with NextCells ProTrans stem cells
NextCell Pharma AB ("NXTCL") announces that an additional three patients have been treated with ProTrans in the ongoing clinical phase I/II trial. In total 6 patients with type 1 diabetes in the low- and medium-dose-cohort have now undergone treatment.
The trial performed with NXTCL's drug candidate ProTrans, is divided into two parts, the first part being a dose-escalation phase with 3 + 3 + 3 patients being treated with either a; low, medium or high dose of ProTrans. Now all patients in the low-dose-cohort and the medium-dose-cohort have been treated. After the 1-month follow-up of the medium-dose-cohort is completed we can start inclusion of patients in the high-dose-cohort. Both the treatment and follow-up procedure are the same for the high-dose-cohort.
The second part of the trial is a randomized, double-blind, placebo-controlled trial in which 10 patients receive ProTrans and 5 patients receive placebo. In this trial a total of 24 patients will be treated with ProTrans. The primary safety endpoint is drug safety and the primary efficacy endpoint is the change in insulin production after 1 year.
The clinical trial is conducted by the Karolinska Trial Alliance and headed by Professor Per-Ola Carlsson from Uppsala University, who is the principal investigator for the trial. The Data Safety Monitoring Board for the trial consists of Professors Ulf Smith and Anders Fasth from the University of Gothenburg, and Åke Lernmark from 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 April18th, 2018.
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Mathias Svahn, CEO
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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 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.