Ignite Creation Date:
2025-12-24 @ 4:45 PM
Ignite Modification Date:
2026-01-05 @ 6:17 PM
Study NCT ID:
NCT06293950
Status:
RECRUITING
Last Update Posted:
2025-01-24
First Post:
2023-05-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Allogeneic Wharton Jelly Mesenchymal Stromal Cell (WJMSC) for Treatment of Autism
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 14}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-03-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2027-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-23', 'studyFirstSubmitDate': '2023-05-09', 'studyFirstSubmitQcDate': '2024-02-27', 'lastUpdatePostDateStruct': {'date': '2025-01-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'safety profile lab tests', 'timeFrame': 'follow-up duration is 12 months', 'description': '-patients will be monitored for any possible adverse events resulting from the injection of MSCs.'}], 'secondaryOutcomes': [{'measure': 'efficacy change in Adult ADHD Self-Report Scale (ASRS)', 'timeFrame': 'follow-up duration is 12 months', 'description': '-The subjects will be monitored with ASRS at baseline, 3, 6, 9, and 12 months'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['autism', 'WJMSC'], 'conditions': ['Autism']}, 'descriptionModule': {'briefSummary': 'Autism spectrum disorders (ASDs) are characterized by core domains: persistent deficits in social communication and interaction; restricted, repetitive patterns of behavior, interests, or activities.', 'detailedDescription': 'Autism spectrum disorders (ASDs) are characterized by core domains: persistent deficits in social communication and interaction; restricted, repetitive patterns of behavior, interests, or activities. ASDs comprise heterogeneous and complex neuro-developmental pathologies with well-defined inflammatory conditions and immune system dysfunction. Due to neurobiological changes underlying ASD development, cell-based therapies have been proposed and applied to ASDs. Indeed, stem cells show specific immunologic properties, which make them promising candidates for ASD treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '14 Years', 'minimumAge': '4 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* 14 subjects, 4-14 years of age, will be enrolled into this study, who meet the criteria for (ASD\n\nExclusion Criteria:\n\n* Age \\> 14 years.\n* Patient weighing \\< 10 kg.\n* History of severe Allergy\n* History of severe head trauma, defined by loss of consciousness or hospitalization, skull fracture, or stroke.\n* Seizure within the last year before enrollment, or the need for seizure medications either at present or in the past.\n* Evidence or history of severe, moderate, or uncontrolled systemic disease.\n* Inability to follow the prescribed dosing and follow-up schedule.\n* Use of any stimulant or non-stimulant medication or medications given for attention deficit hyperactivity disorder (ADHD) must be discontinued 7 days before the initial randomized study period.\n* Subjects taking a selective serotonin reuptake inhibitor (SSRI) must be on a stable dose for a minimum of 30 days before entering the study.\n* History of premature birth \\<35 weeks' gestation.\n* Prior history of stroke in utero or other in utero insult."}, 'identificationModule': {'nctId': 'NCT06293950', 'briefTitle': 'Allogeneic Wharton Jelly Mesenchymal Stromal Cell (WJMSC) for Treatment of Autism', 'organization': {'class': 'OTHER', 'fullName': 'University of Jordan'}, 'officialTitle': 'Allogeneic Wharton Jelly Mesenchymal Stromal Cell (WJMSC) for Treatment of Autism', 'orgStudyIdInfo': {'id': 'AUTISM'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'WJMSC', 'description': '\\- Patients receive three intravenous doses of MSCs (1 million/kg) every two weeks as treatment.', 'interventionNames': ['Biological: WJMSC']}], 'interventions': [{'name': 'WJMSC', 'type': 'BIOLOGICAL', 'description': '\\- Patients receive three intravenous doses of MSCs (1 million/kg) every two weeks as treatment.', 'armGroupLabels': ['WJMSC']}]}, 'contactsLocationsModule': {'locations': [{'zip': '00962', 'city': 'Amman', 'status': 'RECRUITING', 'country': 'Jordan', 'contacts': [{'name': 'Hanan Jafar, PhD', 'role': 'CONTACT', 'email': 'hanan.jafar@gmail.com', 'phone': '00962798871087'}, {'name': 'Abdallah Awidi, MD', 'role': 'CONTACT', 'email': 'abdalla.awidi@gmail.com', 'phone': '0096265355000', 'phoneExt': '23960'}], 'facility': 'Cell Therapy Center', 'geoPoint': {'lat': 31.95522, 'lon': 35.94503}}], 'centralContacts': [{'name': 'Hanan Jafar, PhD', 'role': 'CONTACT', 'email': 'hanan.jafar@gmail.com', 'phone': '00962798871087'}, {'name': 'Abdallah Awidi, MD', 'role': 'CONTACT', 'email': 'abdalla.awidi@gmail.com', 'phone': '0096265355000', 'phoneExt': '23960'}], 'overallOfficials': [{'name': 'Abdallah Awidi, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Cell Therapy Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Jordan', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Hanan Jafar', 'investigatorAffiliation': 'University of Jordan'}}}}