Allogeneic Umbilical Cord Mesenchymal Stem Cell Therapy for Autism

Translational Biosciences

Status and phase: Completed; Phase 2; Phase 1

Conditions: Autism

Treatments: Biological: Umbilical cord mesenchymal stem cells

Study type: Interventional

Funder types: Industry

Identifiers

NCT02192749

TBS-UCMSC-ASD001

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Ages: 6 to 16 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Umbilical cord mesenchymal stem cells

Experimental group

Treatment:

Biological: Umbilical cord mesenchymal stem cells