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)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06293950
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