Allogeneic Umbilical Cord Mesenchymal Stem Cell Therapy for Autism

Open, Prospective Trial of Treatment of Autism Spectrum Disorders (ASD) Using Intravenous Infusion of Umbilical Cord Tissue Mesenchymal Stem Cells (UC-MSC)

Allogeneic (not from the subject) human umbilical cord tissue-derived stem cells administered intravenously (IV) in a series of 4 infusions every 3 months over the course of one year is safe and will induce a therapeutic effect in autism patients.

Inclusion Criteria:

• Male or Female
• Ages 6 to 16
• Diagnostic and Statistical Manual of Mental Disorders (DSM IV) diagnosis of autism confirmed by Autism Diagnostic Observation Schedule (ADOS) and/or Autism Diagnostic Interview-Revised (ADI-R)
• No anticipated changes in treatment for the study duration (e.g., diet, nutrients)
• No additional biomedical treatments started 6 weeks prior to enrollment
• No changes in dietary management for 3 months prior to enrollment
• Ambulatory or require minimum support walking, per parent
• Able to sit still for 5 minutes or longer with a preferred toy item, per parent
• Adequate vision and hearing for the purposes of test administration, per parent
• Adequate arm-hand-finger coordination (i.e., able to point) for learning and cognitive tasks used in outcome measurement, per parent
• Stable and controlled mental disorder
• Under the care of a caregiver willing to participate by attending regularly scheduled appointments and completing the necessary measures
• Normal heavy metals test for lead and mercury levels performed within 30 days of first stem cell infusion
• Must provide name and specialty of specialist who has made Autism Spectrum Disorder (ASD) diagnosis
• Adequate financial means to cover $7,200 (US Dollars) plus travel expenses

Exclusion Criteria:

• Significant prematurity at birth (less than 32 weeks gestation); or birth weight significantly below normal for gestational age (SGA - small for gestational age)
• mental retardation
• seizure disorder
• auto-immune conditions
• history of head trauma and other neurological or medical conditions
• Abnormal heavy metals test for lead and mercury performed within 30 days of first stem cell infusion
• Prior stem cell therapy of any kind