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Allogeneic Umbilical Cord Mesenchymal Stem Cell Therapy for Autism

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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

Tracking Information
First Submitted Date  ICMJE July 12, 2014
First Posted Date  ICMJE July 17, 2014
Last Update Posted Date October 13, 2017
Study Start Date  ICMJE July 2014
Actual Primary Completion Date August 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 15, 2014)
Number of participants with adverse events [ Time Frame: 89 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02192749 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 15, 2014)
  • 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 ]
  • 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 ]
  • Change from baseline macrophage-derived chemokine (MDC) [ Time Frame: 13 weeks, 25 weeks, 37 weeks, 49 weeks, 89 weeks ]
  • Change from baseline thymus and activation-regulated chemokine (TARC) [ Time Frame: 13 weeks, 25 weeks, 37 weeks, 49 weeks, 89 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Allogeneic Umbilical Cord Mesenchymal Stem Cell Therapy for Autism
Official Title  ICMJE Open, Prospective Trial of Treatment of Autism Spectrum Disorders (ASD) Using Intravenous Infusion of Umbilical Cord Tissue Mesenchymal Stem Cells (UC-MSC)
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Autism
Intervention  ICMJE Biological: Umbilical cord mesenchymal stem cells
Study Arms  ICMJE Experimental: Umbilical cord mesenchymal stem cells
Intervention: Biological: Umbilical cord mesenchymal stem cells
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 15, 2014)
20
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 2017
Actual Primary Completion Date August 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Years to 16 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Panama
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02192749
Other Study ID Numbers  ICMJE TBS-UCMSC-ASD001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Translational Biosciences
Study Sponsor  ICMJE Translational Biosciences
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Nelson Novarro, MD
Principal Investigator: Jorge Paz-Rodriguez, MD Translational Biosciences / Stem Cell Institute Panama
PRS Account Translational Biosciences
Verification Date October 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP