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Umbilical Cord Blood vs Personalized Treatments for Improving Autistic Disorder

Primary Purpose

Autistic Spectrum Disorder

Status

Completed

Phase

Phase 1

Locations

Romania

Study Type

Interventional

Intervention

Intranasal oxytocin

Autologous umbilical cord blood

About this trial

This is an interventional treatment trial for Autistic Spectrum Disorder

Eligibility Criteria

3 Years - 7 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

diagnosis of autistic spectrum disorder

Exclusion Criteria:

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

Sites / Locations

Spitalul Angiomedica
Medicover Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Oxytocin

Autologous umbilical cord blood

Arm Description

Intranasal Oxytocin

Intravenous administration of autologous umbilical cord blood

Outcomes

Primary Outcome Measures

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

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

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

Secondary Outcome Measures

Full Information

NCT ID

NCT04007224

First Posted

January 28, 2019

Last Updated

August 21, 2023

Sponsor

Fundatia Bio-Forum

Collaborators

Spitalul Angiomedica

1. Study Identification

Unique Protocol Identification Number

NCT04007224

Brief Title

Umbilical Cord Blood vs Personalized Treatments for Improving Autistic Disorder

Official Title

Comparison of Umbilical Cord Blood vs Personalized Treatment for Improving Autistic Spectrum Disorder

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Completed

Study Start Date

January 17, 2019 (Actual)

Primary Completion Date

June 28, 2023 (Actual)

Study Completion Date

July 10, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Fundatia Bio-Forum

Collaborators

Spitalul Angiomedica

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Autistic Spectrum Disorder

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

35 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Oxytocin

Arm Type

Active Comparator

Arm Description

Intranasal Oxytocin

Arm Title

Autologous umbilical cord blood

Arm Type

Experimental

Arm Description

Intravenous administration of autologous umbilical cord blood

Intervention Type

Drug

Intervention Name(s)

Intranasal oxytocin

Other Intervention Name(s)

non-invasive treatment

Intervention Description

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

Intervention Type

Biological

Intervention Name(s)

Autologous umbilical cord blood

Other Intervention Name(s)

invasive treatment

Intervention Description

patients aged between 3 and 7 years will receive one-time intravenously the processed umbilical cord blood collected at the respective child's birth

Primary Outcome Measure Information:

Title

Improvement in behaviour, interaction with family and peers

Description

change in scores on M-CHAT (Modified Checklist for Autism in Toddlers) questionnaire; total score, maximum 20, lower is better

Time Frame

At 2 months after administration of either treatment

Title

Improvement in behavior and social interaction

Description

change in score on Q-CHAT (Quantitative Checklist for Autism in Toddlers) questionnaire; total score, maximum 100, lower is better

Time Frame

At 2 months after administration of either treatment

Title

Improvement in overall functioning of the child

Description

change in score on CAST (The Childhood Autistic Spectrum Test) questionnaire; Total score, maximum 39, lower is better

Time Frame

At 2 months after administration of either treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

3 Years

Maximum Age & Unit of Time

7 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: diagnosis of autistic spectrum disorder Exclusion Criteria: metabolic or genetic disorder (ex storage disease, Down, etc),

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Felician Stancioiu, M.D.

Organizational Affiliation

Fundatia Bio-Forum

Official's Role

Principal Investigator

Facility Information:

Facility Name

Spitalul Angiomedica

City

Bucharest

State/Province

Bucuresti

ZIP/Postal Code

040245

Country

Romania

Facility Name

Medicover Hospital

City

Bucharest

Country

Romania

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

36818273

Citation

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.

Results Reference

background

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Umbilical Cord Blood vs Personalized Treatments for Improving Autistic Disorder

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