NCT04007224 is a Phase 1 clinical trial of Intranasal oxytocin in Autistic Spectrum Disorder, sponsored by Fundatia Bio-Forum.

Who is sponsoring NCT04007224?

NCT04007224 is sponsored by Fundatia Bio-Forum.

What drugs are being tested in NCT04007224?

Interventions in NCT04007224: Intranasal oxytocin, Autologous umbilical cord blood.

What condition does NCT04007224 study?

NCT04007224 studies Autistic Spectrum Disorder.

Is NCT04007224 still recruiting?

NCT04007224 is currently completed. Last updated 23 August 2023.

Last reviewed 2023-08-23 · How we verify

NCT04007224

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Umbilical Cord Blood vs Personalized Treatments for Improving Autistic Disorder

Completed Phase 1 Last updated 23 August 2023

What this trial tests

Phase 1 trial testing Intranasal oxytocin in Autistic Spectrum Disorder in 35 participants. Completed in 10 July 2023.

Timeline

17 January 2019

Primary endpoint
28 June 2023

10 July 2023

Quick facts

Lead sponsor	Fundatia Bio-Forum
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	35
Start date	17 January 2019
Primary completion	28 June 2023
Estimated completion	10 July 2023
Sites	2 locations across Romania

Drugs / interventions tested

Intranasal oxytocin — full drug profile →
Autologous umbilical cord blood — full drug profile →

Conditions studied

Autistic Spectrum Disorder — all drugs for Autistic Spectrum Disorder →

Sponsor

Fundatia Bio-Forum

Who can join

Adults 3 to 7, any sex, with Autistic Spectrum Disorder. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

Neuron-Specific Enolase (NSE) as a Biomarker for Autistic Spectrum Disease (ASD).
Stancioiu F, Bogdan R, Dumitrescu R. · · 2023 · cited 7× · PMID 37629593 · DOI 10.3390/life13081736
Decontamination of Two Umbilical Cord Blood Grafts Prior to Autologous Administration.
Stancioiu F, Bogdan R, Bulumac B, Ivanescu B, et al · · 2022 · cited 2× · PMID 36818273 · DOI 10.26574/maedica.2022.17.4.885
Autism spectrum disorder and the role of nuclear hormone receptors: insights and therapeutic implications.
Chintalapally S, Rajanala K, Upadhyay A. · · 2025 · PMID 41245836 · DOI 10.3389/fnins.2025.1655348
Autologous cord blood <i>vs</i> individualized supplements in autistic spectrum disorder: CORDUS study results.
Stancioiu FA, Bogdan R, Ivanescu B, Dumitrescu R. · · 2025 · PMID 40059901 · DOI 10.5409/wjcp.v14.i1.96643

Verify or expand the search:

Other trials of Intranasal oxytocin

Trials testing the same drug.

NCT07053774 — Intranasal and Intravenous Oxytocin for Analgesia to Noxious Heat Pain · Phase 2 · recruiting
NCT06405737 — Oxytocin's Effect on the Advantageous- and Disadvantageous-inequity · NA · completed
NCT05312008 — Does Oxytocin Alter Tolerance to or Motivation for Alcohol · Phase 2 · terminated
NCT05265806 — The Effects of Oxytocin Treatment on Social Touch · NA · completed
NCT05245708 — Effects of Oxytocin on Reinforcement Learning and Interoception · NA · completed

Other recruiting trials for Autistic Spectrum Disorder

Currently open trials in the same condition.

NCT05910502 — Project AFECT (Autism Family Empowerment Coaching and Training Program) · NA · active not recruiting
NCT05492032 — Cumulative and Booster Effects of Multisession Prefrontal Transcranial Direct Current Stimulation in Adolescents With AS · NA · recruiting

Other Fundatia Bio-Forum trials

Trials by the same sponsor.

NCT03535974 — Efficacy of a Spirulina Supplement for Amelioration of Benign ThYroid Nodules · NA · completed
NCT03543917 — Post-Stroke Improvement of Motor Function · Phase 1 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04007224 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Fundatia Bio-Forum
Last refreshed: 23 August 2023

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04007224.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing