NCT02192749

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jul 2014

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2014

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

July 12, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 17, 2014

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2017

Completed
Last Updated

October 13, 2017

Status Verified

October 1, 2017

Enrollment Period

3.1 years

First QC Date

July 12, 2014

Last Update Submit

October 12, 2017

Conditions

Autism

Keywords

autismumbilical cordmesenchymalstem cells

Outcome Measures

Primary Outcomes (1)

  • Number of participants with adverse events

    89 weeks

Secondary Outcomes (4)

  • 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

Study Arms (1)

Umbilical cord mesenchymal stem cells

EXPERIMENTAL
Biological: Umbilical cord mesenchymal stem cells

Interventions

Umbilical cord mesenchymal stem cellsBIOLOGICAL
Umbilical cord mesenchymal stem cells

Eligibility Criteria

Age6 Years - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stem Cell Institute

Panama City, Panama

Location

MeSH Terms

Conditions

Autistic Disorder

Condition Hierarchy (Ancestors)

Autism Spectrum DisorderChild Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Study Officials

  • Nelson Novarro, MD

    PRINCIPAL INVESTIGATOR

  • Jorge Paz-Rodriguez, MD

    Translational Biosciences / Stem Cell Institute Panama

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 12, 2014

First Posted

July 17, 2014

Study Start

July 1, 2014

Primary Completion

August 1, 2017

Study Completion

August 1, 2017

Last Updated

October 13, 2017

Record last verified: 2017-10

Locations

PA(1)