Allogeneic Umbilical Cord Mesenchymal Stem Cell Therapy for Autism

October 12, 2017 updated by: Translational Biosciences

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Panama
      • Panama City, Panama
        • Stem Cell Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 16 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Umbilical cord mesenchymal stem cells
Biological: Umbilical cord mesenchymal stem cells

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of participants with adverse events
Time Frame: 89 weeks
89 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
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
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
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
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
13 weeks, 25 weeks, 37 weeks, 49 weeks, 89 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Translational Biosciences

Investigators

  • Principal Investigator: Nelson Novarro, MD
  • Principal Investigator: Jorge Paz-Rodriguez, MD, Translational Biosciences / Stem Cell Institute Panama

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2014

Primary Completion (Actual)

August 1, 2017

Study Completion (Actual)

August 1, 2017

Study Registration Dates

First Submitted

July 12, 2014

First Submitted That Met QC Criteria

July 15, 2014

First Posted (Estimate)

July 17, 2014

Study Record Updates

Last Update Posted (Actual)

October 13, 2017

Last Update Submitted That Met QC Criteria

October 12, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TBS-UCMSC-ASD001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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