Ignite Creation Date:
2025-12-24 @ 12:21 PM
Ignite Modification Date:
2025-12-24 @ 12:21 PM
Study NCT ID:
NCT05315661
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-02-21
First Post:
2022-03-01
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Safety and The Efficacy Evaluation of ET-STEM in Patients With Frontotemporal Dementia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D057180', 'term': 'Frontotemporal Dementia'}], 'ancestors': [{'id': 'D057174', 'term': 'Frontotemporal Lobar Degeneration'}, {'id': 'D003704', 'term': 'Dementia'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D057177', 'term': 'TDP-43 Proteinopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D057165', 'term': 'Proteostasis Deficiencies'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Single Group'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 12}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2022-07-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-02-20', 'studyFirstSubmitDate': '2022-03-01', 'studyFirstSubmitQcDate': '2022-03-30', 'lastUpdatePostDateStruct': {'date': '2024-02-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To determine DLT (Dose limiting toxicity)', 'timeFrame': 'First 3-week cycle of treatment', 'description': 'incidence rate of DLT (Dose limiting toxicity)'}, {'measure': 'adverse events as assessed by CTCAE v5.0', 'timeFrame': 'up to 5years', 'description': 'all potentially treated subjects to assess the safety'}], 'secondaryOutcomes': [{'measure': 'ADAS-Cog 13 response rate', 'timeFrame': 'Screening, after the first administration12weeks, 48weeks, 96weeks, 144weeks, 192weeks, 240weeks', 'description': 'response rate, no change or improvement on ADAS cog 13 score'}, {'measure': 'The Clinical Dementia Rating Sum of Boxes', 'timeFrame': 'Screening, after the first administration12weeks, 48weeks, 96weeks, 144weeks, 192weeks, 240weeks', 'description': 'Change from the baseline in CDR-SB, min 0, max 24, higher scores mean a worse outcome'}, {'measure': "Alzheimer's Disease Cooperative Study- instrumental items of the Activities of Daily Living Inventory", 'timeFrame': 'the first administration12weeks, 48weeks, 96weeks, 144weeks, 192weeks, 240weeks', 'description': 'Change from the baseline in ADCS-iADL, min 0, max78, higher scores mean a better outcome'}, {'measure': 'Caregiver-administered Neuropsychiatric Inventory', 'timeFrame': 'the first administration12weeks, 48weeks, 96weeks, 144weeks, 192weeks, 240weeks', 'description': 'Change from the baseline in CGA-NPI, min 0, max 144, higher scores mean a worse outcome'}, {'measure': 'preliminary efficacy', 'timeFrame': 'up to 12weeks', 'description': 'Change from the baseline in CSF biomarkers'}, {'measure': 'K-MMSE', 'timeFrame': 'the first administration12weeks, 48weeks, 96weeks, 144weeks, 192weeks, 240weeks', 'description': 'Korean Mini-Mental State Examination(MMSE), min 0, max 30, higher scores mean a better outcome'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Frontotemporal Dementia']}, 'descriptionModule': {'briefSummary': 'The primary purpose of this study is to evaluate the safety and the tolerability of 3 repeated doses of ET-STEM (Mesenchymal stem cells preconditioned with ethionamide) in patients with FTD.', 'detailedDescription': 'Subjects with FTD, who signed the informed consent form and meet the eligibility criteria will undergo Ommaya reservoir insertion. 2 weeks after Ommaya reservoir insertion, the subjects will be injected with 3x10\\^7 cells/2mL of ET-STEM to intraventricular space via an Ommaya reservoir. The injection will be repeated 3 times at 4 week intervals. The subjects will be hospitalized for 24 hours and observed for acute adverse events. 4 weeks after the 3rd injection, safety and potential efficacy will be assessed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Korean male or female at 40-85 years of age\n2. Diagnosis of one of the 3 subtyes of FTD according to the diagnostic criteria for 3 subtypes of FTD\n\n ① Probable bvFTD (behavior variant FTD)\n\n ② svPPA (semantic variant primary progressive aphasia)\n\n ③ nfvPPA (nonfluent/agrammatic variant primary progressive aphasia)\n3. K-MMSE ≥ 10\n4. Subjects with trusted caregivers who regularly contact the subjects and can accompany the subjects when visiting the hospital.\n5. Negative result of amyloid PET imaging\n6. A subject who is informed of the clinical trial and signs a consent form (If unable to sign, a consent from a legally acceptable representative is required)\n\nExclusion Criteria:\n\n1. Subjects with dementia cause by other than FTD (i.e. infection of central nervous system, Creutzfeld-Jacob disease, severer head trauma, Huntington's disease, Parkinson's disease, Alzheimer's disease and vascular dementia)\n2. Subjects with psychological disorder. (i.e. depression, schizophrenia , bipolar disorder, etc) (except for subjects who were misdiagnosed with psychological disease due to the initial neuropsychiatric symptoms of FTD)\n3. Subjects with uncontrolled hypotension, hypertension, diabetes and thyroid disease.\n4. Subjects with a cancer (including brain tumor)\n5. Subjects with bleeding disorder\n6. Woman of childbearing age who refused to practice medically acceptable contraceptive method (post menopausal patient with no menstruation for at least 12 months is considered as infertile)\n7. Pregnant or lactating females\n8. History of stroke within 3 months prior to study enrollment\n9. Substance/alcohol abuse 1\n10. Contraindicated for any of the tests performed during the clinical trial period(for example, MRI, CT,PET)\n11. A subject in whom Ommaya reservoir insertion and general anesthesia are considered difficult\n12. Abnormal Laboratory findings at Screening\n13. Suspected active lung disease based on chest X-ray at Screening\n14. Positive hepatitis B nuclear antibody and hpatitis C antibody\n15. Subjects who the principal investigator considers inappropriate for participation in the study due to the possible harmful effect on the subjects,difficulty in study completion, or previous or current medical conditions that may disturb evaluation of study results\n16. Subjects who the principal investigator considers impossible to comply with clinical research procedures."}, 'identificationModule': {'nctId': 'NCT05315661', 'acronym': 'FTD_ET-STEM', 'briefTitle': 'The Safety and The Efficacy Evaluation of ET-STEM in Patients With Frontotemporal Dementia', 'organization': {'class': 'OTHER', 'fullName': 'Samsung Medical Center'}, 'officialTitle': 'Clinical Assessment on the Safety and Potential Efficacy of Mesenchymal Stem Cells Preconditioned With Ethionamide (ET-STEM) in Patients With Frontotemporal Dementia (FTD)', 'orgStudyIdInfo': {'id': '2022-02-089'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment Arm', 'description': 'injected with 3x10\\^7 cells/2mL of ET-STEM to intraventricular space via an Ommaya reservoir. repeated 3 times at 4 week intervals', 'interventionNames': ['Drug: ET-STEM']}], 'interventions': [{'name': 'ET-STEM', 'type': 'DRUG', 'description': 'mesenchymal stem cells preconditioned with ethionamide', 'armGroupLabels': ['Treatment Arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06351', 'city': 'Seoul', 'state': 'Gangnam-gu', 'country': 'South Korea', 'facility': 'Samsung Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'HeeJin Kim', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Samsung Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Samsung Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'assistant professor', 'investigatorFullName': 'Hee Jin Kim', 'investigatorAffiliation': 'Samsung Medical Center'}}}}