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

Last updated: January 23, 2025
Sponsor: University of Jordan
Overall Status: Active - Recruiting

Phase

1

Condition

Autism

Autism Spectrum Disorder (Asd)

Treatment

WJMSC

Clinical Study ID

NCT06293950
AUTISM
  • Ages 4-14
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

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 medicationseither 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 attentiondeficit hyperactivity disorder (ADHD) must be discontinued 7 days before the initialrandomized study period.

  • Subjects taking a selective serotonin reuptake inhibitor (SSRI) must be on a stabledose 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 Design

Total Participants: 14
Treatment Group(s): 1
Primary Treatment: WJMSC
Phase: 1
Study Start date:
March 09, 2022
Estimated Completion Date:
December 31, 2027

Study 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.

Connect with a study center

  • Cell Therapy Center

    Amman, 00962
    Jordan

    Active - Recruiting

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