Autologous Bone Marrow Stem Cell Therapy Combined With Psychological Therapy and Rehabilitation for Autism
NCT ID: NCT03225651
Last Updated: 2019-09-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
30 participants
INTERVENTIONAL
2017-07-18
2019-08-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Stem cell transplantation
Stem cell transplantation 2 intrathecal administrations of autologous bone marrow mononuclear cells at baseline and 6 months afterward
Stem cell transplantation
Transplantation of Autologous Bone Marrow Mononuclear cells
Psychological therapy and Rehabilitation
Psychological Therapy and Rehabilitation for autism children around 3 months
Psychological therapy and rehabilitation
Psychological therapy Rehabilitation in 3 months
Stem cell transplantation
Transplantation of Autologous Bone Marrow Mononuclear cells
Psychological therapy and Rehabilitation
Psychological Therapy and Rehabilitation for autism children around 3 months
Interventions
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Stem cell transplantation
Transplantation of Autologous Bone Marrow Mononuclear cells
Psychological therapy and Rehabilitation
Psychological Therapy and Rehabilitation for autism children around 3 months
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Hydrocephalus with ventricular drain
* Coagulation disorders
* Allergy to anesthetic agents
* Severe health conditions such as cancer, failure of heart, lung, liver or kidney
* Active infections
* Severe psychiatric disorders
* Rett syndrome
* Fragile X syndrome
3 Years
7 Years
ALL
Yes
Sponsors
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Vinmec Research Institute of Stem Cell and Gene Technology
OTHER
Responsible Party
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Locations
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Vinmec Research Institute of Stem Cell and Gene Technology
Hanoi, , Vietnam
Countries
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References
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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.
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.
Other Identifiers
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VinmecRISCGT69
Identifier Type: -
Identifier Source: org_study_id
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