Autism
Conditions
Keywords
autism, WJMSC
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.
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
BIOLOGICALWJMSC
\- Patients receive three intravenous doses of MSCs (1 million/kg) every two weeks as treatment.
Sponsors
University of Jordan
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
4 Years to 14 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| safety profile lab tests | follow-up duration is 12 months | -patients will be monitored for any possible adverse events resulting from the injection of MSCs. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| efficacy change in Adult ADHD Self-Report Scale (ASRS) | follow-up duration is 12 months | -The subjects will be monitored with ASRS at baseline, 3, 6, 9, and 12 months |
Countries
Jordan
Contacts
Primary ContactHanan Jafar, PhD
Backup ContactAbdallah Awidi, MD
Outcome results
None listed