ASC - Autism Pilot Study

• Status: Not yet recruiting
• Trial end date: 2026-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cell2Cure ApS

Criteria

Inclusion Criteria:

• Diagnosis of autism spectrum disorder.

• Ongoing gastrointestinal symptoms or previous gastrointestinal symptoms which disappeared or were reduced after dietary changes.

• Age 6 to 14 years.

Exclusion Criteria:

• Known genetic syndrome or pathogenic mutation or copy number variation associated with autism spectrum disorder.

• Known CNS-infection (now or previously) and/or HIV positivity.

• Primary immunodeficiency disorder or autoimmune cytopenia.

• Current treatment with cytotoxic drugs or systemic administered glucocorticoids and/or immunosuppressive therapy or other antiinflammatory medication (except nonsteroidal anti-inflammatory drugs).

• Epilepsy or known seizure disorder (now or previously).