The first two children with autism spectrum disorder (ASD) and signs of leaky gut syndrome were treated October 2023 with allogeneic adipose-derived mesenchymal stem cells (C2C_ASCs) at Aalborg University Hospital without any complication.
The project is a collaboration between Cell2Cure and Professor Marlene Briciet Lauritsen, Department of Child and Adolescent Psychiatry, Aalborg University, Aalborg University Hospital, and Endeavour Cells ApS, who holds the C2C_ASC sublicense from Cell2Cure for this indication.
The study hypothesis is that the connection between gastrointestinal symptoms/leaky gut syndrome increases local gastrointestinal and systemic elevated immunological and inflammatory activity, bacterial toxins in the blood and symptoms of ASD in children with symptoms of leaky gut syndrome can be reduced or normalized by modulating the immunological activity and inflammation by treatment with C2C_ASCs.
This phase I clinical study is investing the safety and efficacy of treatment with C2C_ASCs. In the study a total of 10 children with autism and signs of leaky gut syndrome will be enrolled. The children will be treated with intravenous infusion of 1 million ASCs per Kg body weight or 2 million ASCs per Kg body weight.
Endeavour Cells is financial sponsor of the trial, and Cell2Cure is the clinical sponsor.
This treatment concept has the potential to become a pioneering treatment of children with autism spectrum disorders and signs of leaky gut syndrome.