Using stem cells from Wharton jelly to treat autism
Allogeneic Wharton Jelly Mesenchymal Stromal Cell (WJMSC) for Treatment of Autism
PHASE1 · University of Jordan · NCT06293950
This study is testing if stem cells from Wharton jelly can help children with autism improve their social skills and behavior.
Quick facts
| Phase | PHASE1 |
|---|---|
| Study type | Interventional |
| Enrollment | 14 (estimated) |
| Ages | 4 Years to 14 Years |
| Sex | All |
| Sponsor | University of Jordan (other) |
| Locations | 1 site (Amman) |
| Trial ID | NCT06293950 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the use of allogeneic Wharton Jelly Mesenchymal Stromal Cells (WJMSC) as a potential treatment for Autism Spectrum Disorders (ASDs). The study aims to enroll 14 participants aged 4 to 14 years who meet the criteria for ASD, focusing on the immunologic properties of stem cells to address the neurobiological changes associated with autism. Participants will receive WJMSC and be monitored for improvements in social communication and behavioral patterns. The trial is designed to assess the safety and efficacy of this innovative approach in a Phase 1 setting.
Who should consider this trial
Good fit: Ideal candidates for this study are children aged 4 to 14 years diagnosed with Autism Spectrum Disorders.
Not a fit: Patients over the age of 14, those with severe allergies, or those with a history of significant neurological issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a novel therapeutic option for children with autism, potentially improving their social communication and behavioral symptoms.
How similar studies have performed: While the use of stem cells in treating autism is a novel approach, preliminary studies in related areas have shown promise, but this specific application remains largely untested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 14 subjects, 4-14 years of age, will be enrolled into this study, who meet the criteria for (ASD 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.
Where this trial is running
Amman
- Cell Therapy Center — Amman, Jordan (RECRUITING)
Study contacts
- Study coordinator: Hanan Jafar, PhD
- Email: hanan.jafar@gmail.com
- Phone: 00962798871087
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Autism, autism, WJMSC