Allogeneic Umbilical Cord Mesenchymal Stem Cell Therapy for Autism
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
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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.
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Ages Eligible for Study:
6 Years to 16 Years (Child)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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
Significant prematurity at birth (less than 32 weeks gestation); or birth weight significantly below normal for gestational age (SGA - small for gestational age)
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