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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Umbilical cord mesenchymal stem cells | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Umbilical cord mesenchymal stem cells | Biological |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with adverse events | 89 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nelson Novarro, MD | Principal Investigator | |
| Jorge Paz-Rodriguez, MD | Translational Biosciences / Stem Cell Institute Panama | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stem Cell Institute | Panama City | Panama |
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| ID | Term |
|---|---|
| D001321 | Autistic Disorder |
| ID | Term |
|---|---|
| D000067877 | Autism Spectrum Disorder |
| D002659 | Child Development Disorders, Pervasive |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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| 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 |