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Umbilical Cord Blood vs Personalized Treatments for Improving Autistic Disorder

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04007224
Recruitment Status : Recruiting
First Posted : July 5, 2019
Last Update Posted : February 21, 2023
Sponsor:
Collaborator:
Spitalul Angiomedica
Information provided by (Responsible Party):
Fundatia Bio-Forum

Study Description
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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.
Study Design
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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 Umbilical Cord Blood vs Personalized Treatment for Improving Autistic Spectrum Disorder
Actual Study Start Date : January 17, 2019
Estimated Primary Completion Date : June 28, 2023
Estimated Study Completion Date : July 10, 2023

Resource links provided by the National Library of Medicine

Drug Information available for: Oxytocin

Arms and Interventions
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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


Outcome Measures
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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


Eligibility Criteria
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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),
Contacts and Locations
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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


Contacts
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Contact: Felician Stancioiu +40727500402 felicians11@gmail.com

Locations
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Romania
Spitalul Angiomedica Completed
Bucharest, Bucuresti, Romania, 040245
Medicover Hospital Recruiting
Bucharest, Romania
Contact: Raluca Bogdan, MD         
Principal Investigator: Radu Dumitrescu, MD         
Sub-Investigator: Raluca Bogdan, MD         
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:
Study Protocol, Statistical Analysis Plan, and Informed Consent Form  [PDF] October 14, 2021

More Information
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Responsible Party: Fundatia Bio-Forum
ClinicalTrials.gov Identifier: NCT04007224    
Other Study ID Numbers: CORDUS
First Posted: July 5, 2019    Key Record Dates
Last Update Posted: February 21, 2023
Last Verified: February 2023
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