What We Do
Ongoing clinical trial with ProTrans
NextCell Pharma is conducting a clinical trial with ProTrans for treatment of 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. This is a two-part phase I/II trial design assessing the safety and efficacy of the study drug. In the first part, a dose-escalation with three patients in 3 dose cohorts is used to evaluate the safety. The second part of the trial is started after all patients in the first part have been to the 1-month follow-up visit. The second part includes 15 patients that are randomized to active treatment or placebo (2:1 ratio), both patients and investigators are blinded.
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.
Update on the clinical trial: Now recruiting patients into fase-II of the trial!
First two patients have been treated in the phase-II part of the clinical trial
Approval by the Data and Safety Monitoring board to proceed with the second part of the trial
All three patients in the high-dose-cohort treated (nine patients have been treated in total)
Approval by the Data and Safety Monitoring board to proceed with the high-dose cohort
All three patients in the medium-dose-cohort treated (six patients have been treated in total)
Approval by the Data and Safety Monitoring Board to proceed with the medium-dose cohort
All three patients in the low-dose-cohort treated
First patient treated
First patient included
First batch of ProTrans clinical grade released for usage in the clinical trial
Initiation meeting at Karolinska Trial Alliance, Huddinge
Karolinska Center for Cell Therapy approves that the trial will be conducted at Karolinska
Permission granted by the Medicinal Product Agency
Permission granted by the Ethics Committee
Clinical trial application submitted
Stem Cells Offer Unlimited Applications
Hematopoietic Stem Cells