Allogeneic Wharton Jelly Mesenchymal Stromal Cell (WJMSC) for Treatment of Autism

University of Jordan

Status and phase: Enrolling; Phase 1

Conditions: Autism

Treatments: Biological: WJMSC

Study type: Interventional

Funder types: Other

Identifiers

NCT06293950

AUTISM

Details and patient eligibility

About

Autism spectrum disorders (ASDs) are characterized by core domains: persistent deficits in social communication and interaction; restricted, repetitive patterns of behavior, interests, or activities.

Full description

Autism spectrum disorders (ASDs) are characterized by core domains: persistent deficits in social communication and interaction; restricted, repetitive patterns of behavior, interests, or activities. ASDs comprise heterogeneous and complex neuro-developmental pathologies with well-defined inflammatory conditions and immune system dysfunction. Due to neurobiological changes underlying ASD development, cell-based therapies have been proposed and applied to ASDs. Indeed, stem cells show specific immunologic properties, which make them promising candidates for ASD treatment.

Enrollment: 14 estimated patients

Sex: All

Ages: 4 to 14 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 14 subjects, 4-14 years of age, will be enrolled into this study, who meet the criteria for (ASD

Exclusion criteria

• Age > 14 years.
• Patient weighing < 10 kg.
• History of severe Allergy
• History of severe head trauma, defined by loss of consciousness or hospitalization, skull fracture, or stroke.
• Seizure within the last year before enrollment, or the need for seizure medications either at present or in the past.
• Evidence or history of severe, moderate, or uncontrolled systemic disease.
• Inability to follow the prescribed dosing and follow-up schedule.
• Use of any stimulant or non-stimulant medication or medications given for attention deficit hyperactivity disorder (ADHD) must be discontinued 7 days before the initial randomized study period.
• Subjects taking a selective serotonin reuptake inhibitor (SSRI) must be on a stable dose for a minimum of 30 days before entering the study.
• History of premature birth <35 weeks' gestation.
• Prior history of stroke in utero or other in utero insult.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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14 participants in 1 patient group

WJMSC

Experimental group

Description:

- Patients receive three intravenous doses of MSCs (1 million/kg) every two weeks as treatment.

Treatment:

Biological: WJMSC