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.
Verified date | June 2023 |
Source | Cell2Cure ApS |
Contact | Jens Kastrup |
Phone | +45 21202994 |
jk[@]cell2cure.com | |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Recruiting |
Enrollment | 10 |
Est. completion date | February 1, 2026 |
Est. primary completion date | February 1, 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 6 Years to 14 Years |
Eligibility | 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). |
Country | Name | City | State |
---|---|---|---|
Denmark | Department of Child and Adolescent Psychiatry, Psychiatry Clinic South, Aalborg University Hospital, Denmark | Aalborg |
Lead Sponsor | Collaborator |
---|---|
Cell2Cure ApS |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Safety of C2C_ASC (Adverse Events) | Safety of C2C_ASC within the 12 weeks follow-up period: Adverse event (AE), serious adverse event (SAE), suspected unexpected serious adverse reaction (SUSAR) and development safety update report (DSUR). | 12 weeks | |
Secondary | Changes in autism spectrum disorder | Difference from baseline to follow-up within the group treated with C2C_ASC:
Changes in autism spectrum disorder score test (questionnaire). [Raw scores converting to standard scores and then generates five major domain composite scores: communication, daily living skills, socialization, adaptive behavior composite and motor. For these domains a standard score of 100 is the mean with a standard deviation of 15. This means that a score of 100 is similar to the typical population of the same age. Scores in the range of 86 and above are considered adequate. Scores in the range of 85 and below indicates a significant skill deficit when comparing with the typical population of the same age. High scores: standard scores of 130-140 Moderately high scores: standard scores of 115-129 Adequate scores: standard scores of 86-114 Moderately low scores: standard scores of 71-85 Low scores: standard scores of 20-70] |
12 weeks | |
Secondary | Changes in gastrointestinal symptoms | Difference from baseline to follow-up within the group treated with C2C_ASC:
Changes in The Infant Gastrointestinal Symptom Questionnaire (questionnaire). [A 0-100 scale where higher scores indicate better irritable bowel syndrome specific quality of life.] |
12 weeks |
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