Ignite Creation Date:
2025-12-24 @ 11:40 PM
Ignite Modification Date:
2026-02-23 @ 8:56 PM
Study NCT ID:
NCT03225651
Status:
COMPLETED
Last Update Posted:
2019-09-06
First Post:
2017-07-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Autologous Bone Marrow Stem Cell Therapy Combined With Psychological Therapy and Rehabilitation for Autism
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2021-07-12', 'releaseDate': '2021-06-21'}], 'estimatedResultsFirstSubmitDate': '2021-06-21'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D001321', 'term': 'Autistic Disorder'}], 'ancestors': [{'id': 'D000067877', 'term': 'Autism Spectrum Disorder'}, {'id': 'D002659', 'term': 'Child Development Disorders, Pervasive'}, {'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D033581', 'term': 'Stem Cell Transplantation'}, {'id': 'D012046', 'term': 'Rehabilitation'}], 'ancestors': [{'id': 'D017690', 'term': 'Cell Transplantation'}, {'id': 'D064987', 'term': 'Cell- and Tissue-Based Therapy'}, {'id': 'D001691', 'term': 'Biological Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D014180', 'term': 'Transplantation'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D000359', 'term': 'Aftercare'}, {'id': 'D003266', 'term': 'Continuity of Patient Care'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'Open Label'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-07-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-11', 'completionDateStruct': {'date': '2019-08-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-09-05', 'studyFirstSubmitDate': '2017-07-05', 'studyFirstSubmitQcDate': '2017-07-19', 'lastUpdatePostDateStruct': {'date': '2019-09-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-07-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-08-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assess the change in autism level by using tools', 'timeFrame': '6 months and 12 months after transplantation', 'description': 'using total score of childhood autism rating scale, autism diagnostic observation schedule second edition, DENVER II, Indian Scale for assessment of Autism'}, {'measure': 'Evaluate the safety of therapy by record number of adverse events', 'timeFrame': 'Through study completion, an average of 12 months'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Stem cell', 'Autism', 'Psychological', 'Rehabilitation'], 'conditions': ['Stem Cell Transplantation']}, 'referencesModule': {'references': [{'pmid': '38114596', 'type': 'DERIVED', 'citation': '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': '32902182', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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', 'detailedDescription': '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'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '7 Years', 'minimumAge': '3 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Confirmed diagnosis of autism according to the Diagnostic and Statistical Manual-V diagnostic criteria for autistic disorder\n\nExclusion Criteria:\n\n* Epilepsy\n* Hydrocephalus with ventricular drain\n* Coagulation disorders\n* Allergy to anesthetic agents\n* Severe health conditions such as cancer, failure of heart, lung, liver or kidney\n* Active infections\n* Severe psychiatric disorders\n* Rett syndrome\n* Fragile X syndrome'}, 'identificationModule': {'nctId': 'NCT03225651', 'acronym': 'ASPRA', 'briefTitle': 'Autologous Bone Marrow Stem Cell Therapy Combined With Psychological Therapy and Rehabilitation for Autism', 'organization': {'class': 'OTHER', 'fullName': 'Vinmec Research Institute of Stem Cell and Gene Technology'}, 'officialTitle': 'Autologous Bone Marrow Stem Cell Therapy Combined With Psychological Therapy and Rehabilitation for Autism: An Open Label Controlled Clinical Trial', 'orgStudyIdInfo': {'id': 'VinmecRISCGT69'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Stem cell transplantation', 'description': 'Stem cell transplantation 2 intrathecal administrations of autologous bone marrow mononuclear cells at baseline and 6 months afterward', 'interventionNames': ['Biological: Stem cell transplantation', 'Behavioral: Psychological therapy and Rehabilitation']}, {'type': 'EXPERIMENTAL', 'label': 'Psychological therapy and rehabilitation', 'description': 'Psychological therapy Rehabilitation in 3 months', 'interventionNames': ['Biological: Stem cell transplantation', 'Behavioral: Psychological therapy and Rehabilitation']}], 'interventions': [{'name': 'Stem cell transplantation', 'type': 'BIOLOGICAL', 'description': 'Transplantation of Autologous Bone Marrow Mononuclear cells', 'armGroupLabels': ['Psychological therapy and rehabilitation', 'Stem cell transplantation']}, {'name': 'Psychological therapy and Rehabilitation', 'type': 'BEHAVIORAL', 'description': 'Psychological Therapy and Rehabilitation for autism children around 3 months', 'armGroupLabels': ['Psychological therapy and rehabilitation', 'Stem cell transplantation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10000', 'city': 'Hanoi', 'country': 'Vietnam', 'facility': 'Vinmec Research Institute of Stem Cell and Gene Technology', 'geoPoint': {'lat': 21.0245, 'lon': 105.84117}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vinmec Research Institute of Stem Cell and Gene Technology', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2021-06-21', 'type': 'RELEASE'}, {'date': '2021-07-12', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Vinmec Research Institute of Stem Cell and Gene Technology'}}}}