The Safety Committee recommends proceeding with part 2 of the stem cell trial in type 1 diabetes
The stem cell company NextCell Pharma AB ("NXTCL") today announced that the Data and Safety Monitoring Board recommends Professor Per-Ola Carlsson Academic Hospital, Uppsala University and NXTCL to proceed with the second part of the clinical trial with ProTrans. Patients with type 1 diabetes aged 18-40 years old who had the disease for a maximum of 2 years and who have some own insulin production are candidates to be included in the study.
The second part of the ProTrans trial is a Phase-II study with the aim to further evaluate the efficacy and safety of ProTrans. The efficacy of the treatment is defined as whether the patient's own insulin production is improved 12 months after treatment with ProTrans stem cells in comparison to patients receiving placebo. The first part of the study, which has now been finalized, consisted of a dose-escalation where a total of 9 patients were treated with low, medium and high dose ProTrans. Now all patients have undergone at minimum a one-month follow-up and the safety committee has reviewed and found ProTrans treatment as safe at all three evaluated doses and thus recommended that the second part of the study should commence.
The second part of the study is randomized, double-blind, placebo-controlled phase-II study, where 10 patients receive ProTrans and 5 patients receive placebo, a total of 15 patients. Primary endpoints are safety and change in insulin production after 1 year. In the study protocol, the medium dose is indicated as treatment dose in the second part. However, the highest dose has been shown to be safe, and an application has been submitted to the Medical Products Agency to use a high dose also in the second part.
The Data and Safety Monitoring Board consists of; Chairman Ulf Smith MD, PhD, Professor and Research Director at 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 at Diabetes and Celiaki, 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 25th of October 2018
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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 autoimmune and 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.