Allogeneic Wharton Jelly Mesenchymal Stromal Cell (WJMSC) for Treatment of Autism

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.

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.