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The aim of this study was to evaluate the safety and effectiveness of autologous bone marrow mononuclear stem cells in the management of autism.
The aim of this study was to evaluate the safety and effectiveness of autologous bone marrow mononuclear stem cells in the management of autism of 24 patients at Vinmec International Hospital, Hanoi, Vietnam
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stem cell transplantation | Experimental | 2 intrathecal administrations of autologous bone marrow mononuclear cells at baseline and 3 months afterward |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Autologous Bone Marrow Mononuclear Cells | Biological | Transplantation of Autologous Bone Marrow Mononuclear Cells |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Total Score of Childhood Autism Rating Scale (CARS) | CARS | 3 months and 6 months after transplantation |
| Number of adverse events | Examples of adverse events to look for: vomiting, increased hyperactivity, fever, bleeding, hematoma, seizures and neurological deficits | Through study completion, an average of 6 months |
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Inclusion Criteria:
- Confirmed diagnosis of autism according to the Diagnostic and Statistical Manual-IV (DSM-IV) diagnostic criteria for autistic disorder
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Liem T Nguyen, MD., PhD. | Vinmec Healthcare System | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vinmec International Hospital | Hanoi | Vietnam |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24062774 | Background | Sharma A, Gokulchandran N, Sane H, Nagrajan A, Paranjape A, Kulkarni P, Shetty A, Mishra P, Kali M, Biju H, Badhe P. Autologous bone marrow mononuclear cell therapy for autism: an open label proof of concept study. Stem Cells Int. 2013;2013:623875. doi: 10.1155/2013/623875. Epub 2013 Aug 25. |
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The data without personal identifiers will be published on Dryad.
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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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