ASC - Autism Study

Phase 1

Recruiting

• Conditions: Autism Spectrum Disorder; Gastrointestinal Dysfunction; Leaky Gut Syndrome; Mesenchymal Stromal Cells; Inflammatory Bowel Diseases

• Registration Number: NCT05602116
• Lead Sponsor: Cell2Cure ApS

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-9-23
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

Inclusion Criteria:<br><br> - Diagnosis of autism spectrum disorder.<br><br> - Ongoing gastrointestinal symptoms or previous gastrointestinal symptoms which<br> disappeared or were reduced after dietary changes.<br><br> - Age 6 to 14 years.<br><br>Exclusion Criteria:<br><br> - Known genetic syndrome or pathogenic mutation or copy number variation associated<br> with autism spectrum disorder.<br><br> - Known CNS-infection (now or previously) and/or HIV positivity.<br><br> - Primary immunodeficiency disorder or autoimmune cytopenia.<br><br> - Current treatment with cytotoxic drugs or systemic administered glucocorticoids<br> and/or immunosuppressive therapy or other antiinflammatory medication (except<br> nonsteroidal anti-inflammatory drugs).<br><br> - Epilepsy or known seizure disorder (now or previously).

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Safety of C2C_ASC (Adverse Events)

Secondary Outcome Measures

Name	Time	Method
Changes in autism spectrum disorder;Changes in gastrointestinal symptoms