Umbilical Cord Blood vs Personalized Treatments for Improving Autistic Disorder
Comparison of Umbilical Cord Blood vs Personalized Treatment for Improving Autistic Spectrum Disorder
1 other identifier
interventional
35
1 country
2
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Jan 2019
Longer than P75 for phase_1
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 17, 2019
CompletedFirst Submitted
Initial submission to the registry
January 28, 2019
CompletedFirst Posted
Study publicly available on registry
July 5, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 28, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
July 10, 2023
CompletedAugust 23, 2023
August 1, 2023
4.4 years
January 28, 2019
August 21, 2023
Conditions
Outcome Measures
Primary Outcomes (3)
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
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
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
Study Arms (2)
Oxytocin
ACTIVE COMPARATORIntranasal Oxytocin
Autologous umbilical cord blood
EXPERIMENTALIntravenous administration of autologous umbilical cord blood
Interventions
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
patients aged between 3 and 7 years will receive one-time intravenously the processed umbilical cord blood collected at the respective child's birth
Eligibility Criteria
You may qualify if:
- diagnosis of autistic spectrum disorder
You may not qualify if:
- metabolic or genetic disorder (ex storage disease, Down, etc),
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Fundatia Bio-Forumlead
- Spitalul Angiomedicacollaborator
Study Sites (2)
Spitalul Angiomedica
Bucharest, București, 040245, Romania
Medicover Hospital
Bucharest, Romania
Related 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.
PMID: 36818273BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Felician Stancioiu, M.D.
Fundatia Bio-Forum
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 28, 2019
First Posted
July 5, 2019
Study Start
January 17, 2019
Primary Completion
June 28, 2023
Study Completion
July 10, 2023
Last Updated
August 23, 2023
Record last verified: 2023-08
Data Sharing
- IPD Sharing
- Will not share