The Danish Medicines Agency has November 23rd, 2022, approved the un-blinded phase I dose-titrating clinical trial where children with autism and signs of leaky gut syndrome are treated with allogeneic adipose-derived mesenchymal stem cells (ASCs). The children will be treated with intravenous infusion of 1 million ASCs per Kg body weight or 2 million ASCs per Kg body weight.
The project is a collaboration between Cell2Cure and Aalborg University, Aalborg University Hospital, and Endeavour Cells ApS, who holds the sublicense from Cell2Cure for this indication.
The participants will be enrolled and treated at Aalborg University Hospital.
Endeavour Cells will financially sponsor the trial, but Cell2Cure will have the role as clinical sponsor.
It is expected that the trial will be ready to enroll the first participant January 2023.