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

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

Recruiting
4-14 years
All
Phase 1

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Overview

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

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.

Eligibility

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.

Study details
    Autism

NCT06293950

University of Jordan

16 October 2025

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