Autistic Spectrum Disorder
Conditions
Brief summary
The clinical study evaluates in an open-label, crossover design the comparative efficacy and safety of intranasal oxytocin and autologous umbilical cord blood for improving the functioning of children with autistic spectrum disorder
Detailed description
Children aged 3-7 years diagnosed with autistic spectrum disorder and who did not previously receive oxytocin or umbilical cord blood treatments, will be enrolled to receive both treatments in random order. Assessment of functioning impairment will be done with QCHAT/M-CHAT/CAST questionnaires initially, at 2 months, 6 months and 1 year after first treatments. Either oxytocin or cord blood will be administered initially and at visit 2, which will take place at 2 months. All children will receive both treatments. A total of 25-40 children are expected to enroll and complete the study.
Interventions
DRUGIntranasal oxytocin
daily administration of oxytocin, 10 UI intrnasal, 5 UI bid, and if needed curcumin orally 250 mg bid, and/or lecithin 500 mg bid, and/or pironoquinolinquinone, 20 mg qd
BIOLOGICALAutologous umbilical cord blood
patients aged between 3 and 7 years will receive one-time intravenously the processed umbilical cord blood collected at the respective child's birth
Sponsors
Spitalul Angiomedica
Fundatia Bio-Forum
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
3 Years to 7 Years
Healthy volunteers
No
Inclusion criteria
* diagnosis of autistic spectrum disorder
Exclusion criteria
* metabolic or genetic disorder (ex storage disease, Down, etc),
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Improvement in behaviour, interaction with family and peers | At 2 months after administration of either treatment | change in scores on M-CHAT (Modified Checklist for Autism in Toddlers) questionnaire; total score, maximum 20, lower is better |
| Improvement in behavior and social interaction | At 2 months after administration of either treatment | change in score on Q-CHAT (Quantitative Checklist for Autism in Toddlers) questionnaire; total score, maximum 100, lower is better |
| Improvement in overall functioning of the child | At 2 months after administration of either treatment | change in score on CAST (The Childhood Autistic Spectrum Test) questionnaire; Total score, maximum 39, lower is better |
Countries
Romania
Outcome results
None listed