Autistic Spectrum DisorderPhase 1NCT04007224
Umbilical Cord Blood vs Personalized Treatments for Improving Autistic Disorder
A Phase 1 study testing Intranasal oxytocin and Autologous umbilical cord blood in people with Autistic Spectrum Disorder, run by Fundatia Bio-Forum at 2 sites in Romania.
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 Read more about this study
- Who is it for?
- Ages 3 to 7 years
- Conditions the study is for
- Autistic Spectrum Disorder
- What is being tested?
- Intranasal oxytocin and Autologous umbilical cord blood
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 2 sitesRomania
- Study dates
- 17 Jan 2019to 10 Jul 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 7 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- diagnosis of autistic spectrum disorder
Who cannot join
- metabolic or genetic disorder (ex storage disease, Down, etc),
Trial locations and contacts
2 sites in 1 country.
Romania2 sites
Spitalul Angiomedica
Bucharest, Bucharest, 040245
Medicover Hospital
Bucharest
About this study
Official title: Comparison of Umbilical Cord Blood vs Personalized Treatment for Improving Autistic Spectrum Disorder
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
Read the detailed 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.
- Conditions
- Autistic Spectrum Disorder
- Being tested
- Intranasal oxytocin, Autologous umbilical cord blood
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intranasal oxytocinDrug
Also called non-invasive treatment
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
Autologous umbilical cord bloodBiological
Also called invasive treatment
patients aged between 3 and 7 years will receive one-time intravenously the processed umbilical cord blood collected at the respective child's birth
| Study group | Role | What they receive |
|---|---|---|
| Oxytocin | Active comparator | Intranasal Oxytocin Receives: Drug: Intranasal oxytocin |
| Autologous umbilical cord blood | Experimental | Intravenous administration of autologous umbilical cord blood Receives: Biological: Autologous umbilical cord blood |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: At 2 months after administration of either treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2019
- Study start17 Jan 2019
- Primary completion28 Jun 2023
- Study completion10 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Autistic Spectrum DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundatia Bio-Forum
- Sponsor type
- University, hospital or other
- Collaborators
- Spitalul Angiomedica
- Responsible party
- Sponsor
- Investigators
- Felician Stancioiu, M.D., Principal investigator, Fundatia Bio-Forum
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04007224
- Sponsor's protocol ID
- CORDUS
- Status last verified
- Aug 2023
- First submitted
- 28 Jan 2019
- Last updated
- 23 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 36818273
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Umbilical Cord Blood vs Personalized Treatment for Improving Autistic Spectrum Disorder
- ClinicalTrials.gov ID
- NCT04007224
- Acronym / sponsor ID
- CORDUS
- Conditions
- Autistic Spectrum Disorder
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Fundatia Bio-ForumUniversity, hospital or other
- Collaborators
- Spitalul Angiomedica
- Study start
- 17 Jan 2019 (actual)
- Primary completion
- 28 Jun 2023 (actual)
- Study completion
- 10 Jul 2023 (actual)
- First posted
- 5 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oxytocin | Active comparator | Drug: Intranasal oxytocinIntranasal Oxytocin |
| Autologous umbilical cord blood | Experimental | Biological: Autologous umbilical cord bloodIntravenous administration of autologous umbilical cord blood |
Who may qualify
- Ages
- 3 to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- diagnosis of autistic spectrum disorder
Key exclusion criteria (1 listed)
- metabolic or genetic disorder (ex storage disease, Down, etc),
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intranasal oxytocinAlso: non-invasive treatmentdaily 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 | Drug | Oxytocin |
| Autologous umbilical cord bloodAlso: invasive treatmentpatients aged between 3 and 7 years will receive one-time intravenously the processed umbilical cord blood collected at the respective child's birth | Biological | Autologous umbilical cord blood |
Primary outcome
Improvement in behaviour, interaction with family and peers
Time frame: At 2 months after administration of either treatment
change in scores on M-CHAT (Modified Checklist for Autism in Toddlers) questionnaire; total score, maximum 20, lower is better
Improvement in behavior and social interaction
Time frame: At 2 months after administration of either treatment
change in score on Q-CHAT (Quantitative Checklist for Autism in Toddlers) questionnaire; total score, maximum 100, lower is better
Improvement in overall functioning of the child
Time frame: At 2 months after administration of either treatment
change in score on CAST (The Childhood Autistic Spectrum Test) questionnaire; Total score, maximum 39, lower is better
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2023.
- Background: PubMed 36818273Stancioiu 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Felician Stancioiu, M.D. principal investigator
Fundatia Bio-Forum
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Intranasal oxytocin and Autologous umbilical cord blood in people with Autistic Spectrum Disorder, run by Fundatia Bio-Forum at 2 sites in Romania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Romania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in behaviour, interaction with family and peers (time frame: At 2 months after administration of either treatment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04007224, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2023.