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

Phase 1

Recruiting

• Conditions: Autism
• Interventions: Biological: WJMSC

• Registration Number: NCT06293950
• Lead Sponsor: University of Jordan

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2022-03-09
• Study First Submitted: 2023-05-09
• Status Verified: 2024-02
• Study First Submitted QC: 2024-02-27
• Last Update Submitted: 2024-02-27
• Study First Posted: 2024-03-05
• Last Update Posted: 2024-03-05
• Primary Completion: 2024-06
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 14

Inclusion Criteria

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
safety profile lab tests	follow-up duration is 12 months	-patients will be monitored for any possible adverse events resulting from the injection of MSCs.

Secondary Outcome Measures

Name	Time	Method
efficacy change in Adult ADHD Self-Report Scale (ASRS)	follow-up duration is 12 months	-The subjects will be monitored with ASRS at baseline, 3, 6, 9, and 12 months

Trial Locations

Locations (1)

Cell Therapy Center; 🇯🇴 Amman, Jordan