Allogenic adipose-tissue-derived mesenchymal stem cells for Autism spectrum disorder | Gastrointestinal symptoms

Inclusion criteria

• {"criterion_text":"- Aged 6-18 years (both inclusive)\n- Diagnosis of autism spectrum disorder\n- Ongoing gastrointestinal symptoms"}

Exclusion criteria

• {"criterion_text":"- If known genetic syndrome or pathogenic mutation or copy number variation associated with autism spectrum disorder\n- Known CNS-infection (now or previously) and/or HIV positivity\n- Primary immunodeficiency disorder or autoimmune cytopenia\n- Celiac disease or inflammatory bowel disease (Crohn’s disease or ulcerative colitis)\n- Current treatment with cytotoxic drugs or systemic administered glucocorticoids and/or immunosuppressive therapy or other anti-inflammatory medication (except nonsteroidal anti-inflammatory drugs)"}

Primary endpoints

• {"endpoint_text":"- Number of adverse reactions (ARs) and serious adverse reactions (SARs)","definition_or_measurement_approach":""}

Secondary endpoints

• {"endpoint_text":"- Change in Vineland Adaptive Behavior Scales (questionnaire)","definition_or_measurement_approach":"Assessed by Vineland Adaptive Behavior Scales questionnaire"}
• {"endpoint_text":"- Change in Children Communication Checklist-2 (questionnaire)","definition_or_measurement_approach":"Assessed by Children Communication Checklist-2 questionnaire"}
• {"endpoint_text":"- Change in IBS-QoL - Irritable Bowel Syndrome Quality of Life (questionnaire)","definition_or_measurement_approach":"Assessed by IBS-QoL questionnaire"}

Denmark

Earliest CTIS Part Ii Submission Date

05-12-2025

Latest Decision Or Authorization Date

23-01-2026

Processing Time Days

49

Number Of Sites

1

Number Of Participants

40

Primary sponsor

Full Name

Cell to Cure ApS

Organisation Type

Pharmaceutical company

Country Of Registered Address

Denmark

Third parties

• {"country":"Denmark","full_name":"Cts Scandinavia ApS","duties_or_roles":"Code 1","organisation_type":"Pharmaceutical company"}