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Oxytocin Versus Cord Blood for Improving Autistic Disorder

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ClinicalTrials.gov Identifier: NCT04007224
Recruitment Status : Enrolling by invitation
First Posted : July 3, 2019
Last Update Posted : July 3, 2019
Sponsor:
Collaborator:
Spitalul Angiomedica
Information provided by (Responsible Party):
Fundatia Bio-Forum

Brief 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

Condition or disease Intervention/treatment Phase
Autistic Spectrum Disorder Drug: Intranasal oxytocin Biological: Autologous umbilical cord blood Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison of Oxytocin and Umbilical Cord Blood for Improving Autistic Spectrum Disorder
Actual Study Start Date : January 17, 2019
Estimated Primary Completion Date : January 30, 2020
Estimated Study Completion Date : March 31, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Oxytocin

Arm Intervention/treatment
Active Comparator: Oxytocin
Intranasal Oxytocin
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
Other Name: non-invasive treatment

Experimental: Autologous umbilical cord blood
Intravenous administration of autologous umbilical cord blood
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
Other Name: invasive treatment




Primary Outcome Measures :
  1. 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

  2. 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

  3. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years to 7 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • diagnosis of autistic spectrum disorder

Exclusion Criteria:

  • metabolic or genetic disorder (ex storage disease, Down, etc),

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04007224


Locations
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Romania
Spitalul Angiomedica
Bucharest, Bucuresti, Romania, 040245
Sponsors and Collaborators
Fundatia Bio-Forum
Spitalul Angiomedica
Investigators
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Principal Investigator: Felician Stancioiu, M.D. Fundatia Bio-Forum
  Study Documents (Full-Text)

Documents provided by Fundatia Bio-Forum:

Publications of Results:
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Responsible Party: Fundatia Bio-Forum
ClinicalTrials.gov Identifier: NCT04007224     History of Changes
Other Study ID Numbers: CORDUS
First Posted: July 3, 2019    Key Record Dates
Last Update Posted: July 3, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Autistic Disorder
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders
Oxytocin
Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs