Children with autism spectrum disorder and gastrointestinal symptoms. MedDRA version: 20.0 Level: LLT Classification code 10008520 Term: Childhood autism System Organ Class: 100000004873 MedDRA version: 20.1 Level: LLT Classification code 10013225 Term: Disorder gastrointestinal System Organ Class: 100000004856
Conditions
Interventions
Product Name: CSCC_ASC
Product Code: CSCC_ASC5010
Pharmaceutical Form: Concentrate and solvent for dispersion for injection
INN or Proposed INN: CSCC_ASC5010
Current Sponsor code: CSCC_ASC5010
Other d
Sponsors
Cell2Cure ApS
Eligibility
Sex/Gender
All
Inclusion 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 – 14 years. Are the trial subjects under 18? yes Number of subjects for this age range: 10 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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 anti-inflammatory medication (except nonsteroidal anti-inflammatory drugs). Epilepsy or known seizure disorder (now or previously).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate safety and treatment effect of an allogeneic adipose tissue derived mesenchymal stromal cell product (CSCC_ASC) in children with autism spectrum disorder and gastrointestinal symptoms. ;Secondary Objective: Not applicate.;Primary end point(s): Difference from baseline to follow-up within the group treated with CSCC_ASC: Safety within the 12 weeks follow-up period: AE, SAE, SUSAR and DSUR. ;Timepoint(s) of evaluation of this end point: 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Difference from baseline to follow-up within the group treated with CSCC_ASC: Changes in: - Autism spectrum disorder score test. - The Infant Gastrointestinal Symptom Questionnaire. - Faecal microbiota and short-chain fatty acid. - Biomarkers for inflammation, donor tissue type HLA antibodies, biomarkers for assessment of intestinal permeability and for immune cell characterization. ;Timepoint(s) of evaluation of this end point: 12 weeks | — |
Countries
Denmark
Contacts
Public ContactJens Kastrup
Cell2Cure ApS
Outcome results
None listed