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Umbilical Cord Blood vs Personalized Treatments for Improving Autistic Disorder
Plain-language guide to NCT04007224: phase 1 non-randomized trial of Oxytocin, 35 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT04007224
- Phase
- phase 1
- Status
- completed
- Start
- 2019-01-17
- Completion (planned or actual)
- 2023-06-28
- Participants
- 35 (actual)
- Design
- non-randomized, open label (everyone knows who gets what), treatment
- Conditions studied
- Autistic Spectrum Disorder
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
This registered phase 1 trial tested Oxytocin.
It had two arms (groups): Oxytocin (active comparator) and Autologous umbilical cord blood (experimental).
Intranasal Oxytocin.
Intravenous administration of autologous umbilical cord blood.
The registry classes the interventions as biological and drug.
More on the Plan
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.
Who Took Part
The registry lists 35 actual participants took part.
It was open to people of any sex aged from 3 years up to 7 years.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Diagnosis of autistic spectrum disorder.
The full record lists 1 inclusion and 1 exclusion criteria; among the exclusions: metabolic or genetic disorder (ex storage disease, down, etc),.
How the Study Was Run
It was run as a non-randomized, parallel-group and open-label study.
Groups ran in parallel: each of the participants stayed in one arm throughout.
Being open-label, the Oxytocin study did not mask who received what.
It started in 2019-01-17 with completion listed for 2023-06-28.
It ran at 2 sites in Romania (2).
Its stated primary purpose is treatment.
What This Means in Plain Language
Put simply, this is a phase 1, non-randomized trial of Oxytocin in 35 people.
Its size is small, so on its own it can only give an early look.
The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.
More context: the Oxytocin compound page, all human trials.
Our Notes on the Compound
Oxytocin: A peptide hormone with established obstetric medical uses and a less settled role in research on behavior, sexual function and appetite.
Related Pages
Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.