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Allogeneic Umbilical Cord Mesenchymal Stem Cell Therapy for Autism

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02192749
Recruitment Status : Completed
First Posted : July 17, 2014
Last Update Posted : October 13, 2017
Sponsor:
Information provided by (Responsible Party):
Translational Biosciences

Study Description
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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.

Condition or disease Intervention/treatment Phase
Autism Biological: Umbilical cord mesenchymal stem cells Phase 1 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open, Prospective Trial of Treatment of Autism Spectrum Disorders (ASD) Using Intravenous Infusion of Umbilical Cord Tissue Mesenchymal Stem Cells (UC-MSC)
Study Start Date : July 2014
Actual Primary Completion Date : August 2017
Actual Study Completion Date : August 2017

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Umbilical cord mesenchymal stem cells Biological: Umbilical cord mesenchymal stem cells


Outcome Measures
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Primary Outcome Measures :
  1. Number of participants with adverse events [ Time Frame: 89 weeks ]

Secondary Outcome Measures :
  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 ]

Eligibility Criteria
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Ages Eligible for Study:   6 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02192749


Locations
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Panama
Stem Cell Institute
Panama City, Panama
Sponsors and Collaborators
Translational Biosciences
Investigators
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Principal Investigator: Nelson Novarro, MD
Principal Investigator: Jorge Paz-Rodriguez, MD Translational Biosciences / Stem Cell Institute Panama
More Information
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Responsible Party: Translational Biosciences
ClinicalTrials.gov Identifier: NCT02192749    
Other Study ID Numbers: TBS-UCMSC-ASD001
First Posted: July 17, 2014    Key Record Dates
Last Update Posted: October 13, 2017
Last Verified: October 2017
Keywords provided by Translational Biosciences:
autism
umbilical cord
mesenchymal
stem cells
Additional relevant MeSH terms:
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Autistic Disorder
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders