NCT04007224

Umbilical Cord Blood vs Personalized Treatments for Improving Autistic Disorder

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: Fundatia Bio-Forum · Academic / Other
• Sex: All
• Age: 3 Years – 7 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Autistic Spectrum Disorder

Interventions

Type	Name	Description
DRUG	Intranasal 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
BIOLOGICAL	Autologous 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

Timeline

• Start date: 2019-01-17
• Primary completion: 2023-06-28
• Completion: 2023-07-10
• First posted: 2019-07-05
• Last updated: 2023-08-23

Locations

2 sites across 1 country: Romania