Last updated: February 20, 2024
Sponsor: Samsung Medical Center
Overall Status: Active - Not Recruiting
Phase
1
Condition
Memory Loss
Dementia
Frontotemporal Dementia
Treatment
ET-STEM
Clinical Study ID
NCT05315661
2022-02-089
Ages 40-85 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Korean male or female at 40-85 years of age
- Diagnosis of one of the 3 subtyes of FTD according to the diagnostic criteria for 3subtypes of FTD ① Probable bvFTD (behavior variant FTD) ② svPPA (semantic variant primary progressive aphasia) ③ nfvPPA (nonfluent/agrammatic variant primary progressive aphasia)
- K-MMSE ≥ 10
- Subjects with trusted caregivers who regularly contact the subjects and can accompanythe subjects when visiting the hospital.
- Negative result of amyloid PET imaging
- A subject who is informed of the clinical trial and signs a consent form (If unable tosign, a consent from a legally acceptable representative is required)
Exclusion
Exclusion Criteria:
- Subjects with dementia cause by other than FTD (i.e. infection of central nervoussystem, Creutzfeld-Jacob disease, severer head trauma, Huntington's disease,Parkinson's disease, Alzheimer's disease and vascular dementia)
- Subjects with psychological disorder. (i.e. depression, schizophrenia , bipolardisorder, etc) (except for subjects who were misdiagnosed with psychological diseasedue to the initial neuropsychiatric symptoms of FTD)
- Subjects with uncontrolled hypotension, hypertension, diabetes and thyroid disease.
- Subjects with a cancer (including brain tumor)
- Subjects with bleeding disorder
- Woman of childbearing age who refused to practice medically acceptable contraceptivemethod (post menopausal patient with no menstruation for at least 12 months isconsidered as infertile)
- Pregnant or lactating females
- History of stroke within 3 months prior to study enrollment
- Substance/alcohol abuse 1
- Contraindicated for any of the tests performed during the clinical trial period(forexample, MRI, CT,PET)
- A subject in whom Ommaya reservoir insertion and general anesthesia are considereddifficult
- Abnormal Laboratory findings at Screening
- Suspected active lung disease based on chest X-ray at Screening
- Positive hepatitis B nuclear antibody and hpatitis C antibody
- Subjects who the principal investigator considers inappropriate for participation inthe study due to the possible harmful effect on the subjects,difficulty in studycompletion, or previous or current medical conditions that may disturb evaluation ofstudy results
- Subjects who the principal investigator considers impossible to comply with clinicalresearch procedures.
Study Design
Total Participants: 12
Treatment Group(s): 1
Primary Treatment: ET-STEM
Phase: 1
Study Start date:
July 06, 2022
Estimated Completion Date:
December 31, 2026
Study Description
Connect with a study center
Samsung Medical Center
Seoul, Gangnam-gu 06351
Korea, Republic ofSite Not Available

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