In this study we generated a drug product from culture-expanded and pooled WJMSCs, ProTrans, under the classification of an advanced therapy medicinal product . The aim of this study was to evaluate the safety and efficacy of i.v. infusion of this ‘off-the-shelf’ allogeneic WJMSC product in individuals recently diagnosed with type 1 diabetes.This study was approved by the Swedish Ethical Review Authority and the Swedish Medical Products Agency and registered at ClinicalTrials.gov .
Inclusion criteria were a diagnosis of type 1 diabetes 0.12 nmol/l. Exclusion criteria were BMI >30 kg/m, weight 100 kg, unstable cardiovascular status, active and chronic infections such as tuberculosis, HIV, hepatitis B or C or treponema pallidum infection, ongoing systemic immunosuppressive therapy, demyelinating disease, pregnancy or lactation , malignancy, glucose-lowering therapies other than insulin, a diagnosis of kidney disease defined as an eGFR of less than 80 ml/min per 1.