The Safety and The Efficacy Evaluation of ET-STEM in Patients With Frontotemporal Dementia

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

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.

Eligibility Criteria

Inclusion

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 3subtypes of FTD ① Probable bvFTD (behavior variant FTD) ② svPPA (semantic variant primary progressive aphasia) ③ nfvPPA (nonfluent/agrammatic variant primary progressive aphasia)
  3. K-MMSE ≥ 10
  4. Subjects with trusted caregivers who regularly contact the subjects and can accompanythe 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 tosign, a consent from a legally acceptable representative is required)

Exclusion

Exclusion Criteria:

  1. 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)
  2. 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)
  3. Subjects with uncontrolled hypotension, hypertension, diabetes and thyroid disease.
  4. Subjects with a cancer (including brain tumor)
  5. Subjects with bleeding disorder
  6. 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)
  7. Pregnant or lactating females
  8. History of stroke within 3 months prior to study enrollment
  9. Substance/alcohol abuse 1
  10. Contraindicated for any of the tests performed during the clinical trial period(forexample, MRI, CT,PET)
  11. A subject in whom Ommaya reservoir insertion and general anesthesia are considereddifficult
  12. Abnormal Laboratory findings at Screening
  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 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
  16. 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

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.

Connect with a study center

  • Samsung Medical Center

    Seoul, Gangnam-gu 06351
    Korea, Republic of

    Site Not Available

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