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| Name | Class |
|---|---|
| Spitalul Angiomedica | UNKNOWN |
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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oxytocin | Active Comparator | Intranasal Oxytocin |
|
| Autologous umbilical cord blood | Experimental | Intravenous administration of autologous umbilical cord blood |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intranasal oxytocin | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Felician Stancioiu, M.D. | Fundatia Bio-Forum | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Spitalul Angiomedica | Bucharest | Bucharest | 040245 | Romania | ||
| Medicover Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36818273 | Background | 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. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Oct 14, 2021 | Oct 28, 2021 | Prot_SAP_ICF_002.pdf |
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| ID | Term |
|---|---|
| D000067877 | Autism Spectrum Disorder |
| ID | Term |
|---|---|
| D002659 | Child Development Disorders, Pervasive |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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| Autologous umbilical cord blood | Biological | patients aged between 3 and 7 years will receive one-time intravenously the processed umbilical cord blood collected at the respective child's birth |
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| Bucharest |
| Romania |