Trial | NCT04007224  Report issue

Title

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

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    35
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
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 Started
Jan 17
2019
Primary Completion
Jun 28
2023
Study Completion
Jul 10
2023
Last Update
Aug 23
2023

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

  • Other names: non-invasive treatment

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

  • Other names: invasive treatment

Oxytocin Active Comparator

Intranasal Oxytocin

Autologous umbilical cord blood Experimental

Intravenous administration of autologous umbilical cord blood

Criteria 

Inclusion Criteria:

diagnosis of autistic spectrum disorder

Exclusion Criteria:

metabolic or genetic disorder (ex storage disease, Down, etc),
No Results Posted