Umbilical Cord Blood vs Personalized Treatments for Improving Autistic Disorder

Phase 1

Completed

• Conditions: Autistic Spectrum Disorder
• Interventions: Drug: Intranasal oxytocin; Biological: Autologous umbilical cord blood

• Registration Number: NCT04007224
• Lead Sponsor: Fundatia Bio-Forum

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.

Study Timeline

• Study Start: 2019-01-17
• Study First Submitted: 2019-01-28
• Study First Submitted QC: 2019-07-01
• Study First Posted: 2019-07-05
• Primary Completion: 2023-06-28
• Study Completion: 2023-07-10
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-21
• Last Update Posted: 2023-08-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

Inclusion Criteria

• diagnosis of autistic spectrum disorder

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Oxytocin	Intranasal oxytocin	Intranasal Oxytocin
Autologous umbilical cord blood	Autologous umbilical cord blood	Intravenous administration of autologous umbilical cord blood

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

Spitalul Angiomedica; 🇷🇴 Bucharest, Bucuresti, Romania

Medicover Hospital; 🇷🇴 Bucharest, Romania