Umbilical Cord Blood vs Personalized Treatments for Improving Autistic Disorder

Fundatia Bio-Forum

Status and phase: Completed; Phase 1

Conditions: Autistic Spectrum Disorder

Treatments: Drug: Intranasal oxytocin; Biological: Autologous umbilical cord blood

Study type: Interventional

Funder types: Other

Identifiers

NCT04007224

CORDUS

Details and patient eligibility

About

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

Full 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.

Enrollment: 35 patients

Sex: All

Ages: 3 to 7 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• diagnosis of autistic spectrum disorder

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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35 participants in 2 patient groups

Oxytocin

Active Comparator group

Description:

Intranasal Oxytocin

Treatment:

Drug: Intranasal oxytocin

Autologous umbilical cord blood

Experimental group

Description:

Intravenous administration of autologous umbilical cord blood

Treatment:

Biological: Autologous umbilical cord blood