Umbilical Cord Blood vs Personalized Treatments for Improving Autistic Disorder

NCT ID: NCT04007224

Last Updated: 2023-08-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-17
• Study Completion Date: 2023-07-10

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.

Conditions

Autistic Spectrum Disorder

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Oxytocin

Intranasal Oxytocin

Group Type: ACTIVE_COMPARATOR

Intranasal oxytocin

Intervention Type: 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

Autologous umbilical cord blood

Intravenous administration of autologous umbilical cord blood

Group Type: EXPERIMENTAL

Autologous umbilical cord blood

Intervention Type: 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

Interventions

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

Intervention Type: DRUG

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

Intervention Type: BIOLOGICAL

Other Intervention Names

non-invasive treatment; invasive treatment

Eligibility Criteria

Inclusion Criteria

• diagnosis of autistic spectrum disorder

Exclusion Criteria

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

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 7 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Spitalul Angiomedica

UNKNOWN

Sponsor Role: collaborator

Fundatia Bio-Forum

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Felician Stancioiu, M.D.

Role: PRINCIPAL_INVESTIGATOR

Fundatia Bio-Forum

Locations

Spitalul Angiomedica

Bucharest, București, Romania

Medicover Hospital

Bucharest, , Romania

Countries

Romania

References

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.

Reference Type: BACKGROUND

PMID: 36818273 (View on PubMed)

Provided Documents

Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

CORDUS

Identifier Type: -

Identifier Source: org_study_id