RecruitingPhase 1NCT06293950

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


Sponsor

University of Jordan

Enrollment

14 participants

Start Date

Mar 9, 2022

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 4 YearsMax Age: 14 Years

Inclusion Criteria1

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

Exclusion Criteria11

  • 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.

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Interventions

BIOLOGICALWJMSC

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


Locations(1)

Cell Therapy Center

Amman, Jordan

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NCT06293950


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