Ethical approval for the allogeneic adipose tissue-derived mesenchymal stromal/stem cell (ASC) phase I clinical trial in children with autism and leaky gut syndrome

The Danish Medical Research Ethics Committees has November 2nd, 2022, approved a phase I dose-titrating clinical trial with allogeneic adipose tissue-derived mesenchymal stromal/stem cell (ASC) treatment of children with autism and leaky gut syndrome.

The project is a collaboration between Cell2Cure, Aalborg University, Aalborg University Hospital, Hvidovre 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 in early 2023.