Status:
COMPLETED
Allogeneic Umbilical Cord Mesenchymal Stem Cell Therapy for Autism
Lead Sponsor:
Translational Biosciences
Conditions:
Autism
Eligibility:
All Genders
6-16 years
Phase:
PHASE1
PHASE2
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2017
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT02192749
Start Date
July 1 2014
End Date
August 1 2017
Last Update
October 13 2017
Active Locations (1)
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1
Stem Cell Institute
Panama City, Panama