Allogeneic Wharton Jelly Mesenchymal Stromal Cell (WJMSC) for Treatment of Autism
1 other identifier
interventional
14
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Mar 2022
Longer than P75 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 9, 2022
CompletedFirst Submitted
Initial submission to the registry
May 9, 2023
CompletedFirst Posted
Study publicly available on registry
March 5, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2027
January 24, 2025
January 1, 2025
4.2 years
May 9, 2023
January 23, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
safety profile lab tests
-patients will be monitored for any possible adverse events resulting from the injection of MSCs.
follow-up duration is 12 months
Secondary Outcomes (1)
efficacy change in Adult ADHD Self-Report Scale (ASRS)
follow-up duration is 12 months
Study Arms (1)
WJMSC
EXPERIMENTAL\- Patients receive three intravenous doses of MSCs (1 million/kg) every two weeks as treatment.
Interventions
\- Patients receive three intravenous doses of MSCs (1 million/kg) every two weeks as treatment.
Eligibility Criteria
You may qualify if:
- subjects, 4-14 years of age, will be enrolled into this study, who meet the criteria for (ASD
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Cell Therapy Center
Amman, 00962, Jordan
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Abdallah Awidi, MD
Cell Therapy Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal investigator
Study Record Dates
First Submitted
May 9, 2023
First Posted
March 5, 2024
Study Start
March 9, 2022
Primary Completion (Estimated)
June 1, 2026
Study Completion (Estimated)
December 1, 2027
Last Updated
January 24, 2025
Record last verified: 2025-01