Umbilical Cord Blood vs Personalized Treatments for Improving Autistic Disorder

Study Overview
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Brief Summary
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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
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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.

Official Title
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Comparison of Umbilical Cord Blood vs Personalized Treatment for Improving Autistic Spectrum Disorder

Conditions
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Autistic Spectrum Disorder

Intervention / Treatment
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* Drug: Intranasal oxytocin
* Biological: Autologous umbilical cord blood


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: diagnosis of autistic spectrum disorder Exclusion Criteria: metabolic or genetic disorder (ex storage disease, Down, etc),

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 7 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Oxytocin<br>Intranasal Oxytocin | Drug: Intranasal oxytocin<br>* 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<br>* Other names: non-invasive treatment;|
| Experimental: Autologous umbilical cord blood<br>Intravenous administration of autologous umbilical cord blood | Biological: Autologous umbilical cord blood<br>* patients aged between 3 and 7 years will receive one-time intravenously the processed umbilical cord blood collected at the respective child's birth<br>* Other names: invasive treatment;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in behaviour, interaction with family and peers | change in scores on M-CHAT (Modified Checklist for Autism in Toddlers) questionnaire; total score, maximum 20, lower is better | At 2 months after administration of either treatment | 
| Improvement in behavior and social interaction | change in score on Q-CHAT (Quantitative Checklist for Autism in Toddlers) questionnaire; total score, maximum 100, lower is better | At 2 months after administration of either treatment | 
| Improvement in overall functioning of the child | change in score on CAST (The Childhood Autistic Spectrum Test) questionnaire; Total score, maximum 39, lower is better | At 2 months after administration of either treatment |