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
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Autism | Biological: Umbilical cord mesenchymal stem cells | Phase 1 Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 20 participants |
Allocation: | N/A |
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 |

Arm | Intervention/treatment |
---|---|
Experimental: Umbilical cord mesenchymal stem cells |
Biological: Umbilical cord mesenchymal stem cells |
- Number of participants with adverse events [ Time Frame: 89 weeks ]
- 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 ]

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Ages Eligible for Study: | 6 Years to 16 Years (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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
Panama | |
Stem Cell Institute | |
Panama City, Panama |
Principal Investigator: | Nelson Novarro, MD | ||
Principal Investigator: | Jorge Paz-Rodriguez, MD | Translational Biosciences / Stem Cell Institute Panama |
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 |
autism umbilical cord mesenchymal stem cells |
Autistic Disorder Autism Spectrum Disorder Child Development Disorders, Pervasive Neurodevelopmental Disorders Mental Disorders |