None listed
Conditions
Interventions
Biological/Vaccine, Stem Cell : mesenchymal stem cells preconditioned with ethionamide: Ommaya reservor insertion, the subjects will be injected with 3x107 cells/2mL, repeated 3 times at 4 week interv
Sponsors
Samsung Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Korean male or female at 40-85 years of age 2) Diagnosis of one of the 3 subtyes of FTD according to the diagnostic criteria for 3 subtypes of FTD ? Probable bvFTD (behavior variant FTD) ? svPPA (semantic variant primary progressive aphasia) ? nfvPPA (nonfluent/agrammatic variant primary progressive aphasia) 3) K-MMSE = 10 4) Subjects with trusted caregivers who regularly contact the subjects and can accompany the subjects when visiting the hospital. 5) Negative result of amyloid PET imaging 6) 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)
Exclusion criteria
Exclusion criteria: 1) 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) 2) Subjects with psychological disorder. (i.e. depression, schizophremia, bipolar disorder, etc) (except for subjects who were misdiagnosed with psychological disease due to the initial neuropsychiatric symptoms of FTD) 3) Subjects with uncontrolled hypotension, hypertension, diabetes and thyroid disease. 4) Subjects with a cancer (including brain tumor) 5) Subjects with bleeding disorder (abnormal blood coagulation test result (i.e. platelet count of 9.5g/dL for male and < 9.0g/dL for female ? Total WBC Count < 3000/mm3 ? Total Bilirubin = 3mg/dL ? AST/ALT = 100 IU/L 13) Suspected active lung disease based on chest X-ray at Screening 14) Positive hepatitis B nuclear antibody and hpatitis C antibody 15) 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 evlauation of study results 16) Subjects who the principal investigator considers impossible to comply with clinical research procedures.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| DLT(Dose limiting toxicity) | — |
Secondary
| Measure | Time frame |
|---|---|
| K-MMSE, ADAS-cog 13, CDR-SB, ADCS-iADL, CGA-NPI response rate ;Change from the baseline in CSF biomarkers (Amyloid beta 42, Phosphorylated tau, Total tau, RBC, WBC, Glucose, Protein) ;adverse events | — |
Countries
Korea, Republic of
Contacts
Public Contactheejin Kim
Samsung Medical Center
Outcome results
None listed