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Not Yet Recruiting
NCT05602116
ASC - Autism Study
Conditions: Autism Spectrum Disorder, Gastrointestinal Dysfunction, Leaky Gut Syndrome, Mesenchymal Stromal Cells, Inflammatory Bowel Diseases
Sex: All
Ages: 6 Years – 14 Years
Phase: PHASE1
Enrollment: 10
Sponsor: Cell2Cure ApS
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.
Eligibility 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).
Source: ClinicalTrials.gov (NCT05602116). StuddyBuddy aggregates publicly available trial information.
