Autologous Bone Marrow Stem Cell Therapy Combined With Psychological Therapy and Rehabilitation for Autism
ASPRA
1 other identifier
interventional
30
1 country
1
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Jul 2017
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 5, 2017
CompletedStudy Start
First participant enrolled
July 18, 2017
CompletedFirst Posted
Study publicly available on registry
July 21, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 30, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
August 30, 2019
CompletedSeptember 6, 2019
November 1, 2018
2.1 years
July 5, 2017
September 5, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
Study Arms (2)
Stem cell transplantation
EXPERIMENTALStem cell transplantation 2 intrathecal administrations of autologous bone marrow mononuclear cells at baseline and 6 months afterward
Psychological therapy and rehabilitation
EXPERIMENTALPsychological therapy Rehabilitation in 3 months
Interventions
Transplantation of Autologous Bone Marrow Mononuclear cells
Psychological Therapy and Rehabilitation for autism children around 3 months
Eligibility Criteria
You may qualify if:
- Confirmed diagnosis of autism according to the Diagnostic and Statistical Manual-V diagnostic criteria for autistic disorder
You may not qualify if:
- Epilepsy
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Vinmec Research Institute of Stem Cell and Gene Technology
Hanoi, 10000, Vietnam
Related Publications (2)
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.
PMID: 38114596DERIVEDNguyen 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.
PMID: 32902182DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Masking Details
- Open Label
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 5, 2017
First Posted
July 21, 2017
Study Start
July 18, 2017
Primary Completion
August 30, 2019
Study Completion
August 30, 2019
Last Updated
September 6, 2019
Record last verified: 2018-11