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Allogeneic Umbilical Cord Mesenchymal Stem Cell Therapy for Autism

NCT ID: NCT02192749

Last Updated: 2017-10-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-07-31

Study Completion Date

2017-08-31

Brief Summary

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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

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Conditions

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Autism

Keywords

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autism umbilical cord mesenchymal stem cells

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Umbilical cord mesenchymal stem cells

Group Type EXPERIMENTAL

Umbilical cord mesenchymal stem cells

Intervention Type BIOLOGICAL

Interventions

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Umbilical cord mesenchymal stem cells

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Minimum Eligible Age

6 Years

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Translational Biosciences

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Nelson Novarro, MD

Role: PRINCIPAL_INVESTIGATOR

Jorge Paz-Rodriguez, MD

Role: PRINCIPAL_INVESTIGATOR

Translational Biosciences / Stem Cell Institute Panama

Locations

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Stem Cell Institute

Panama City, , Panama

Site Status

Countries

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Panama

Other Identifiers

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TBS-UCMSC-ASD001

Identifier Type: -

Identifier Source: org_study_id