Umbilical Cord Blood vs Personalized Treatments for Improving Autistic Disorder

Autistic Spectrum Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04007224
• Other study ID #: CORDUS
• Status: Completed
• Phase: Phase 1
• Start date: January 17, 2019
• Est. completion date: July 10, 2023

Study information

• Verified date: August 2023
• Source: Fundatia Bio-Forum
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: July 10, 2023
• Est. primary completion date: June 28, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 7 Years

Eligibility

Inclusion Criteria:

• diagnosis of autistic spectrum disorder

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Autism Spectrum Disorder
• Autistic Disorder
• Autistic Spectrum Disorder
• Child Development Disorders, Pervasive

Intervention

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

Locations

Country	Name	City	State
Romania	Medicover Hospital	Bucharest
Romania	Spitalul Angiomedica	Bucharest	Bucuresti

Sponsors (2)

Lead Sponsor	Collaborator
Fundatia Bio-Forum	Spitalul Angiomedica

Country where clinical trial is conducted

Romania, 

References & Publications (1)

Stancioiu F, Bogdan R, Bulumac B, Ivanescu B, Dumitrescu R. Decontamination of Two Umbilical Cord Blood Grafts Prior to Autologous Administration. Maedica (Bucur). 2022 Dec;17(4):885-892. doi: 10.26574/maedica.2022.17.4.885. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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