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| Name | Class |
|---|---|
| Bio Products Laboratory | OTHER |
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If autism is the consequence of a chronic inflammatory process preventing the infant brain from forming the proper neural connections, then treatment that reduces inflammation might have a positive impact on autism. IGIV treatment has been known to suppress inflammation and has been used in the treatment of inflammatory conditions and autoimmune diseases.
We have come to believe that an immature immune system with abnormal signaling and altered apoptotic pathways may result in a process of neuroinflammation with a clinical presentation of Autism Spectrum Disorder. If Autism Spectrum Disorders are the consequence of a chronic inflammatory process that prevents the infant brain from forming the proper neural connections, then treatment that reduces inflammation might have a positive impact on autism. We believe that there is a correlation between immunological abnormalities and the development of the autism.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gammaplex 5% IGIV | Experimental | Gammaplex 5% IGIV administered intravenously |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gammaplex 5% | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| The primary objective is to assess the efficacy of Gammaplex as an immunomodulatory therapy in autistic children with evidence of immune dysfunction. | The primary endpoint is disease improvement, as evidenced by standardized test measures across 3 intervals: screening for baseline measurements, visit 5, and end of study visit measurements. Primary efficacy variables will be measured using the following standardized tests
| 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| The modulatory effect of IVIG on neuroinflammation will be assessed by laboratory measurements which we believe are indicative of immune dysregulation. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| To improve development in autistic spectrum | 1 year |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Isaac Melamed, MD | IMMUNOe International Clinical Research Centers | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IMMUNOe International Research Centers | Centennial | Colorado | 80112 | United States |
| Type | Date | Date Unknown |
|---|---|---|
| Release | May 7, 2018 | |
| Reset | Jun 6, 2018 | |
| Release | Mar 1, 2019 | |
| Reset | Mar 28, 2019 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| May 7, 2018 | Jun 6, 2018 | |||
| Mar 1, 2019 |
| ID | Term |
|---|---|
| D001321 | Autistic Disorder |
| D020817 | Asperger Syndrome |
| D002659 | Child Development Disorders, Pervasive |
| ID | Term |
|---|---|
| D000067877 | Autism Spectrum Disorder |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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| Mar 28, 2019 |