NCT05315661 · Phase 1 · ACTIVE NOT RECRUITING
The Safety and The Efficacy Evaluation of ET-STEM in Patients With Frontotemporal Dementia
This Phase 1 trial is testing whether ET-STEM — mesenchymal stem cells treated with the drug ethionamide — is safe and tolerable when given in three repeated doses to people diagnosed with frontotemporal dementia (FTD). Phase 1 means the focus is on safety, not yet on proving the treatment works. It is a small early-stage study enrolling Korean patients between ages 40 and 85 with confirmed FTD.
You may qualify if
- 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 3 subtypes 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 accompany the 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 to sign, a consent from a legally acceptable representative is required)
You're excluded if
- 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)
- 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)
- 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 contraceptive method (post menopausal patient with no menstruation for at least 12 months is considered 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(for example, MRI, CT,PET)
- A subject in whom Ommaya reservoir insertion and general anesthesia are considered difficult
- 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 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
- Subjects who the principal investigator considers impossible to comply with clinical research procedures.
The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.
Eligibility criteria as of 2024-02-21