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Umbilical Cord Blood vs Personalized Treatments for Improving Autistic Disorder

NCT04007224 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2023-08-23

No results posted yet for this study

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

Conditions

  • Autistic Spectrum Disorder

Interventions

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

Sponsors & Collaborators

  • Spitalul Angiomedica

    collaborator UNKNOWN

  • Fundatia Bio-Forum

    lead OTHER

Principal Investigators

  • Felician Stancioiu, M.D. · Fundatia Bio-Forum

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
7 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-17
Primary Completion
2023-06-28
Completion
2023-07-10

Countries

  • Romania

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04007224 on ClinicalTrials.gov