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OpenTrials
Completed

NCT Number: NCT02192749

Allogeneic Umbilical Cord Mesenchymal Stem Cell Therapy for Autism

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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Key information

Conditions

Autism Autism Spectrum Disorder Autistic Disorder Child Development Disorders, Pervasive Mental Disorders Neurodevelopmental Disorders

Age range

6 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Stem Cell Institute

Panama City, Panama

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Umbilical Cord Mesenchymal Stem Cells

Biological

Primary outcomes

  1. Number of participants with adverse events

    Time frame: 89 weeks

Secondary outcomes

  1. Number of participants with a change in disability as measured by the Autism Treatment Evaluation Checklist (ATEC)

    Time frame: 13 weeks, 25 weeks, 37 weeks, 49 weeks, 89 weeks

  2. Number of participants with a change in disability as measured by the Childhood Autism Rating Scale (CARS)

    Time frame: 13 weeks, 25 weeks, 37 weeks, 49 weeks, 89 weeks

  3. Change from baseline macrophage-derived chemokine (MDC)

    Time frame: 13 weeks, 25 weeks, 37 weeks, 49 weeks, 89 weeks

  4. Change from baseline thymus and activation-regulated chemokine (TARC)

    Time frame: 13 weeks, 25 weeks, 37 weeks, 49 weeks, 89 weeks

Sponsors and collaborators

Lead sponsor

Translational Biosciences

Industry

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Jul 17, 2014
Registry last updated
Oct 13, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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