NCT05602116CompletedPhase 1
ASC - Autism Study
Effect of Adipose Tissue Derived Mesenchymal Stromal Cells on Autism and Leaky Gut Syndrome. A Phase I Pilot Study.
Source: ClinicalTrials.gov · Last updated 26 Sept 2024
Brief summary (registry, in English)
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 (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 10 (actual)
- First submitted
- 23 Sept 2022
- Start date
- 9 Jun 2023
- Primary completion date
- 28 Jun 2024
- Lead sponsor
- Cell to Cure ApS
- Diseases
- Autism
- NCT number
- NCT05602116
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 10
- From 9 Jun 2023 to the primary completion date, 28 Jun 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Known CNS-infection (now or previously) and/or HIV positivity.
- 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).
Other illness
- Known genetic syndrome or pathogenic mutation or copy number variation associated with autism spectrum disorder.
- Primary immunodeficiency disorder or autoimmune cytopenia.
Who the study is looking for
- 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.
Age in the registry: 6 years to 14 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Department of Child and Adolescent Psychiatry, Psychiatry Clinic South, Aalborg University Hospital, Denmark Coordinator of this site? Confirm its status | Aalborg | Denmark | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.