First diabetes patient treated with ProTrans stem cells
NextCell Pharma AB ("NextCell") announces that the first patient with type 1 diabetes has now been treated with the company's drug candidate ProTrans. The clinical trial evaluates the safety and efficacy of ProTrans after treatment of patients 18-40 years old and who had type 1 diabetes for a maximum of two years.
The clinical trial started on November 28th, 2017 and after clinical assessment and baseline data collection, the first patient has now been treated (first-in-human) with ProTrans stem cells.
The first part of the study is a three-step dose escalation with three patients in each cohort, a total of 9 patients. study patients 1-3 will receive a single dose of 25 million cells, patients 4-6 will receive 100 million cells and patients 7-9 will receive 200 million cells. 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. Endpoints include safety and changes in metabolic parameters such as blood glucose values, insulin requirements and endogenous insulin production after one 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 January 24th, 2018.
For more information about NextCell Pharma AB, please contact:
Mathias Svahn, VD
Leo Groenewegen, CFO
Telefon: 08-735 5595
E-post: info@nextcellpharma.com
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.