Actively Recruiting
Allogeneic Wharton Jelly Mesenchymal Stromal Cell (WJMSC) for Treatment of Autism in Children Ages 4 to 14
Led by University of Jordan · Updated on 2025-01-24
14
Participants Needed
1
Research Sites
78 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Autism spectrum disorders (ASDs) are complex neuro-developmental conditions characterized by ongoing difficulties in social communication and interaction, along with restricted and repetitive behaviors or interests. These disorders involve inflammatory conditions and immune system dysfunction, which has led researchers to explore cell-based therapies as a potential treatment. This study is a Phase 1 clinical trial focusing on evaluating the safety and effects of stem cells for children with ASD. Participants in the trial receive three intravenous doses of allogeneic Wharton Jelly Mesenchymal Stromal Cells (WJMSC) at a dose of 1 million cells per kilogram of body weight. These doses are administered every two weeks as the treatment approach. The study aims to assess both safety and efficacy over a follow-up period extending to 12 months after treatment. During the study, researchers monitor participants through laboratory tests to evaluate the safety profile of the treatment. They also measure changes in attention and hyperactivity symptoms using the Adult ADHD Self-Report Scale over a 12-month follow-up. The trial involves children aged 4 to 14 years diagnosed with ASD, with regular assessments and follow-up visits scheduled throughout the year to observe treatment effects and ensure participant safety.
CONDITIONS
Brief Title
Allogeneic Wharton Jelly Mesenchymal Stromal Cell (WJMSC) for Treatment of Autism
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Children aged 4 to 14 years
- Diagnosis of autism spectrum disorder (ASD)
- Ability to comply with dosing and follow-up schedule
- Stable dose of selective serotonin reuptake inhibitor (SSRI) for at least 30 days if applicable
- Discontinuation of ADHD medications at least 7 days before study start
You will not qualify if you...
- Older than 14 years
- Weighing less than 10 kilograms
- History of severe allergy
- History of severe head trauma including loss of consciousness, hospitalization, skull fracture, or stroke
- Seizure within the last year or current/past use of seizure medications
- Severe, moderate, or uncontrolled systemic disease
- Inability to follow dosing and follow-up schedule
- History of premature birth before 35 weeks gestation
- Prior in utero stroke or other in utero insult
- Use of stimulant or non-stimulant ADHD medications within 7 days before study start
- Unstable SSRI dosage within 30 days before study start if applicable
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 6 weeks
Participants receive three intravenous doses of Wharton Jelly Mesenchymal Stromal Cells (WJMSC) at a dose of 1 million cells per kilogram every two weeks.
3 treatment visits (in-person) every two weeks
Duration - 12 months
Participants are monitored for safety and efficacy outcomes for up to 12 months after the final treatment dose.
Periodic follow-up visits over 12 months
Trial Site Locations
Total: 1 location
1
Cell Therapy Center
Amman, Jordan, 00962
Actively Recruiting
Research Team
H
Hanan Jafar, PhD
A
Abdallah Awidi, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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