Allogeneic Wharton Jelly Mesenchymal Stromal Cell (WJMSC) for Treatment of Autism
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: WJMSC.
- Who it may be relevant to
- Registry conditions: Autism. Basic parameters: 4 years — 14 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Jordan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- Biological WJMSC
\- Patients receive three intravenous doses of MSCs (1 million/kg) every two weeks as treatment.
Primary outcome measures
- safety profile lab tests [Time frame: follow-up duration is 12 months]
Secondary outcome measures (1)
- efficacy change in Adult ADHD Self-Report Scale (ASRS) [Time frame: follow-up duration is 12 months]
Eligibility 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Jordan · 1 center
- Cell Therapy Center — Amman
Identifiers
NCT: NCT06293950 · AUTISM