Autism
Conditions
Keywords
autism, umbilical cord, mesenchymal, stem cells
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.
Interventions
BIOLOGICALUmbilical cord mesenchymal stem cells
Sponsors
Translational Biosciences
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Years to 16 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of participants with adverse events | 89 weeks |
Secondary
| Measure | 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 |
Countries
Panama
Outcome results
None listed