Umbilical Cord Blood vs Personalized Treatments for Improving Autistic Disorder

August 21, 2023 updated by: Fundatia Bio-Forum

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

35

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Romania
      • Bucharest, Romania
        • Medicover Hospital
    • Bucuresti
      • Bucharest, Bucuresti, Romania, 040245
        • Spitalul Angiomedica

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 7 years (Child)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • diagnosis of autistic spectrum disorder

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • invasive treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
At 2 months after administration of either treatment
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
At 2 months after administration of either treatment
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
At 2 months after administration of either treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundatia Bio-Forum

Collaborators

Spitalul Angiomedica

Investigators

  • Principal Investigator: Felician Stancioiu, M.D., Fundatia Bio-Forum

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 17, 2019

Primary Completion (Actual)

June 28, 2023

Study Completion (Actual)

July 10, 2023

Study Registration Dates

First Submitted

January 28, 2019

First Submitted That Met QC Criteria

July 1, 2019

First Posted (Actual)

July 5, 2019

Study Record Updates

Last Update Posted (Actual)

August 23, 2023

Last Update Submitted That Met QC Criteria

August 21, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CORDUS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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