ASC - Autism Study

Autism Spectrum Disorder Clinical Trial

Official title: Effect of Adipose Tissue Derived Mesenchymal Stromal Cells on Autism and Leaky Gut Syndrome. A Phase I Pilot Study.

Status Recruiting

Clinical Trial Summary

The ASC - Autism Pilot Study is a single center randomized open dose titrating phase I clinical intervention pilot trial with the aim of investigating safety and treatment effect of an allogeneic adipose tissue derived mesenchymal stromal cell product (C2C_ASC) in children with autism spectrum disorder (ASD) and gastrointestinal symptoms.

Clinical Trial Description

The ASC - Autism Pilot Study will be performed at the Child and Adolescent Psychiatry, Aalborg University Hospital, Denmark. 10 children aged 6-14 years with ASD and gastrointestinal symptoms will be enrolled through the Child and Adolescent Psychiatry, Psychiatry Clinic South, Aalborg University Hospital, Denmark.

The participants will randomly be divied into two treatment groups:

1. participant 1-5 will be treated with 1 x 1000000 C2C_ASCs/kg body weight

2. participant 6-10 will be treated with 2 x 1000000 C2C_ASCs/kg body weight

C2C_ASC treatment:

The C2C_ASCs product will be diluted in 50 ml isotonic saline and infused in an arm vein within 15 min. In both groups there will for each participant be a week observation for SAE's related to the cell treatment before the next participant will be treated, if no SAE's have been detected.

The investigators hypothesize that the connection between gastrointestinal symptoms/leaky gut syndrome, increase 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 mesenchymal stromal cells. ;

Related Conditions & MeSH terms

• Autism Spectrum Disorder
• Autistic Disorder
• Gastrointestinal Dysfunction
• Inflammatory Bowel Diseases
• Leaky Gut Syndrome
• Mesenchymal Stromal Cells
• Syndrome

• NCT number: NCT05602116
• Study type: Interventional
• Source: Cell2Cure ApS
• Contact: Jens Kastrup
• Phone: +45 21202994
• Email: jk@cell2cure.com
• Status: Recruiting
• Phase: Phase 1
• Start date: June 9, 2023
• Completion date: February 1, 2026