Actively Recruiting
Allogeneic Wharton Jelly Mesenchymal Stromal Cell Treatment for Autism Spectrum Disorders Study of Intravenous MSC Doses Over 12 Months Sponsored by University of Jordan
Led by University of Jordan · Updated on 2025-01-24
14
Participants Needed
1
Research Sites
299 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Autism spectrum disorders (ASDs) involve ongoing challenges in social communication and interaction as well as repetitive behaviors and restricted interests. These complex neurodevelopmental conditions also show inflammatory and immune system dysfunction. Researchers are exploring cell-based therapies as a potential treatment due to the underlying neurobiological changes in ASD, and stem cells are being considered because of their unique immune-related properties. Participants in this study receive three intravenous doses of allogeneic Wharton Jelly Mesenchymal Stromal Cells (WJMSC) at 1 million cells per kilogram every two weeks. This treatment is being evaluated to assess its safety and potential effects in children with ASD. The study is conducted in a phase 1 setting focusing on safety and tolerability. During the 12-month follow-up period, participants will undergo laboratory tests to monitor safety. Researchers will track the safety profile through these tests to better understand the impact of the treatment over time. The study enrolls children aged 4 to 14 years and involves careful dosing and follow-up to ensure adherence and participant safety.
CONDITIONS
Official 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
- Diagnosed with autism spectrum disorder (ASD)
- Able to follow the dosing and follow-up schedule
You will not qualify if you...
- Older than 14 years
- Weighing less than 10 kilograms
- History of severe allergy
- History of severe head trauma with loss of consciousness, hospitalization, skull fracture, or stroke
- Seizure within the past year or current/past use of seizure medications
- Severe, moderate, or uncontrolled systemic disease
- Unable to follow dosing and follow-up schedule
- Use of stimulant or non-stimulant ADHD medications within 7 days before study start
- Use of selective serotonin reuptake inhibitors (SSRIs) not stable for at least 30 days before study
- History of premature birth before 35 weeks gestation
- Prior stroke or other insult before birth
AI-Screening
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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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