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| Name | Class |
|---|---|
| Shandong Jiaotong Hospital | UNKNOWN |
| Association for the Handicapped Of Jinan | UNKNOWN |
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Autism is one of those disorders in Autism spectrum disorders (ASD), which characterized by social interaction abnormalities, impaired verbal and non-verbal communication, and repetitive, obsessive behavior, while the therapeutic effect of current treatments remains limited progress .Neural hypoperfusion and immune deregulation are the two key pathologies associated with Autism. Human umbilical cord mesenchymal stem cells (hUC-MSCs) and human cord blood mononuclear cells (hCB-MNCs) have been shown to have the ability to modulate the immune response and enhance angiogenesis, suggesting the novel and promising therapeutic strategy. In this study, the safety and efficacy of hUC-MSCs and hCB-MNCs transplantation will be evaluated in patients with Autism.
To investigate the safety and efficacy of human cord blood mononuclear cells and human umbilical cord mesenchymal stem cells transplantation in patients of Autism.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rehabilitation plus hCB-MNCs treatment | Experimental | Participants will be given rehabilitation therapy plus human cord blood mononuclear cells transplantation with a 6 months follow-up. |
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| Rehabilitation plus hCB-MNCs and hUC-MSCs therapy | Experimental | Participants will be given rehabilitation therapy plus combination of hCB-MNCs together with hUC-MSCs transplantation with a 6 months follow-up. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| human cord blood mononuclear cells | Biological | Participants will be given rehabilitation therapy plus hCB-MNCs transplantation. |
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| Measure | Description | Time Frame |
|---|---|---|
| Childhood Autism Rating Scale,CARS | 6 months after treatment | |
| Clinical Global Impression Scale,CGI | 6 months after treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Aberrant Behavior Checklist,ABC | 6 months after treatment | |
| Adverse Event and Serious Adverse Event | 6 months after treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yongtao Lv | Shandong Jiaotong Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shandong Jiaotong Hospital | Jinan | Shandong | 250031 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | Liu M, Sun LW, LV YT, Huan Y, Ge RC, Cao YL, Guo CQ, Chen XW. Stem cells for treatment of autism: Safety and efficacy. Zhongguo Zuzhi Gongcheng Yanjiu yu Linchuang Kangfu. 2010;14(32): 5967-5970. | ||
| 23978163 | Derived | Lv YT, Zhang Y, Liu M, Qiuwaxi JN, Ashwood P, Cho SC, Huan Y, Ge RC, Chen XW, Wang ZJ, Kim BJ, Hu X. Transplantation of human cord blood mononuclear cells and umbilical cord-derived mesenchymal stem cells in autism. J Transl Med. 2013 Aug 27;11:196. doi: 10.1186/1479-5876-11-196. |
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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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| human cord blood mononuclear cells and human umbilical cord mesenchymal stem cells | Biological | Participants will be given rehabilitation therapy plus and hCB-MNCs and hUC-MSCs transplantation. |
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