NextCell Pharma initiates stem cell trial for type 1-diabetes with ProTrans
NextCell Pharma AB ("NextCell") announces that the initiation meeting for the clinical trial in which drug candidate ProTrans will be evaluated, was held on November 28th, 2017. The trial will investigate safety as well as evaluate the patient’s own insulin production 12 months after receiving ProTrans stem cell treatment. Patients with type 1-diabetes being 18-40 years who received their diagnosis no later than 2 years ago and still have some insulin production are candidates for participation in the trial.
NextCell Pharma has reached a new level as a company. I would like to thank all the hard working collaborators for this achievement. The development in the stem cell area is moving rapidly, and we will continue to do our best to remain at its forefront - to make a difference for people with hard-to-treat and today incurable diseases, says Dr. Mathias Svahn, CEO NextCell Pharma AB.
The first part of the ProTrans study is a three-step dose escalation with three patients in each cohort, a total of 9 patients. The second part of the study is a randomized, double-blind, placebo-controlled study where 10 patients receive ProTrans and 5 patients receive a placebo, a total of 15 patients. The primary safety endpoint is drug safety and the primary efficacy endpoint is the change in insulin production after 1 year.
The sponsor of the study is NextCell and the principal investigator is Professor Per-Ola Carlsson, working at Uppsala University and the Uppsala Academic Hospital. The study is conducted at the KTA Phase I unit located at Karolinska University Hospital in Huddinge. Professor Ulf Smith MD, PhD, Professor Anders Fasth, MD, PhD, and Professor Åke Lernmark PhD, together form the Data Safety Monitoring Board with Ulf Smith as its chairman.
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 November 29, 2017.
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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.