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OpenTrials
Completed

NCT Number: NCT04007224

Umbilical Cord Blood vs Personalized Treatments for Improving Autistic Disorder

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

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Key information

Conditions

Autistic Spectrum Disorder Autism Spectrum Disorder Child Development Disorders, Pervasive Mental Disorders Neurodevelopmental Disorders

Age range

3 year–7 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Spitalul Angiomedica, Bucharest, Romania

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • diagnosis of autistic spectrum disorder

Exclusion criteria

  • metabolic or genetic disorder (ex storage disease, Down, etc),

Treatment and study plan

Intranasal oxytocin

Drug

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

Other names: non-invasive treatment

Autologous umbilical cord blood

Biological

patients aged between 3 and 7 years will receive one-time intravenously the processed umbilical cord blood collected at the respective child's birth

Other names: invasive treatment

Primary outcomes

  1. Improvement in behaviour, interaction with family and peers

    Time frame: 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

  2. Improvement in behavior and social interaction

    Time frame: 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

  3. Improvement in overall functioning of the child

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Fundatia Bio-Forum

Other

Collaborators

  • Spitalul Angiomedica

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Jul 5, 2019
Registry last updated
Aug 23, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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