Allogeneic Umbilical Cord Mesenchymal Stem Cell Therapy for Autism

Study Overview
=================
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 induce a therapeutic effect in autism patients.

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

Conditions
-----------------
Autism

Intervention / Treatment
-----------------
* Biological: Umbilical cord mesenchymal stem cells


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 16 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Umbilical cord mesenchymal stem cells<br> | Biological: Umbilical cord mesenchymal stem cells<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with adverse events |  | 89 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with a change in disability as measured by the Autism Treatment Evaluation Checklist (ATEC) |  | 13 weeks, 25 weeks, 37 weeks, 49 weeks, 89 weeks | 
| Number of participants with a change in disability as measured by the Childhood Autism Rating Scale (CARS) |  | 13 weeks, 25 weeks, 37 weeks, 49 weeks, 89 weeks | 
| Change from baseline macrophage-derived chemokine (MDC) |  | 13 weeks, 25 weeks, 37 weeks, 49 weeks, 89 weeks | 
| Change from baseline thymus and activation-regulated chemokine (TARC) |  | 13 weeks, 25 weeks, 37 weeks, 49 weeks, 89 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
autism, umbilical cord, mesenchymal, stem cells