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The aim of this study was to evaluate the safety and effectiveness of autologous bone marrow mononuclear stem cells combined with Psychological Therapy and Rehabilitation for Autism children
The aim of this study was to evaluate the safety and effectiveness of autologous bone marrow mononuclear stem cells combined with Psychological Therapy and Rehabilitation in the management of autism of 60 patients at Vinmec Research Institute of Stem Cell and Gene Technology Hanoi, Vietnam from January 2017 to December 2018
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stem cell transplantation | Experimental | Stem cell transplantation 2 intrathecal administrations of autologous bone marrow mononuclear cells at baseline and 6 months afterward |
|
| Psychological therapy and rehabilitation | Experimental | Psychological therapy Rehabilitation in 3 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stem cell transplantation | Biological | Transplantation of Autologous Bone Marrow Mononuclear cells |
|
| Measure | Description | Time Frame |
|---|---|---|
| Assess the change in autism level by using tools | using total score of childhood autism rating scale, autism diagnostic observation schedule second edition, DENVER II, Indian Scale for assessment of Autism | 6 months and 12 months after transplantation |
| Evaluate the safety of therapy by record number of adverse events | Through study completion, an average of 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vinmec Research Institute of Stem Cell and Gene Technology | Hanoi | 10000 | Vietnam |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38114596 | Derived | Than UTT, Nguyen LT, Nguyen PH, Nguyen XH, Trinh DP, Hoang DH, Nguyen PAT, Dang VD. Inflammatory mediators drive neuroinflammation in autism spectrum disorder and cerebral palsy. Sci Rep. 2023 Dec 18;13(1):22587. doi: 10.1038/s41598-023-49902-8. | |
| 32902182 | Derived | Nguyen Thanh L, Nguyen HP, Ngo MD, Bui VA, Dam PTM, Bui HTP, Ngo DV, Tran KT, Dang TTT, Duong BD, Nguyen PAT, Forsyth N, Heke M. Outcomes of bone marrow mononuclear cell transplantation combined with interventional education for autism spectrum disorder. Stem Cells Transl Med. 2021 Jan;10(1):14-26. doi: 10.1002/sctm.20-0102. Epub 2020 Sep 9. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jun 21, 2021 | |
| Reset | Jul 12, 2021 |
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Open Label
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| Psychological therapy and Rehabilitation | Behavioral | Psychological Therapy and Rehabilitation for autism children around 3 months |
|
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jun 21, 2021 | Jul 12, 2021 |
| 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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| ID | Term |
|---|---|
| D033581 | Stem Cell Transplantation |
| D012046 | Rehabilitation |
| ID | Term |
|---|---|
| D017690 | Cell Transplantation |
| D064987 | Cell- and Tissue-Based Therapy |
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
| D014180 | Transplantation |
| D013514 | Surgical Procedures, Operative |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
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