MSC-Exosome Therapy for Frontotemporal Dementia
ConditionFrontotemporal Dementia
Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age30-80
SponsorRuijin Hospital
About this trial
This study is testing a new treatment for Frontotemporal Dementia (FTD) - a progressive brain disease that affects personality, behavior, and language. Currently, there is no cure for FTD and no approved medication that can slow down or stop the disease. Existing treatments only help manage some symptoms temporarily.
The investigational treatment in this study is made from exosomes - tiny particles naturally released by umbilical cord stem cells. Exosomes act like "message carriers" between cells. Researchers believe they may help protect brain cells, reduce harmful protein buildup, and improve brain function.
The exosomes will be given as a nasal spray (sprayed into the nose). This method may allow the treatment to reach the brain directly without needing to pass through the blood-brain barrier (a natural protective layer that often blocks medications from entering the brain).
Eligibility criteria
Qualifiers
Diagnosis of probable frontotemporal dementia (FTD), including behavioral variant (bvFTD), semantic variant primary progressive aphasia (svPPA), or non-fluent variant primary progressive aphasia (nfvPPA), according to established diagnostic criteria, with supportive neuroimaging evidence showing frontal and/or temporal lobe atrophy score of 2 or higher on brain CT or MRI.
Age between 30 and 80 years (inclusive) at screening.
Study partner who agrees to participate in the study, provides at least 3 hours of daily care or visits, and can manage all study medication.
Frontotemporal Lobar Degeneration Clinical Dementia Rating (FTLD-CDR) score of 0-2 and Mini-Mental State Examination (MMSE) score greater than 10 at screening.
Disqualifiers
History of stroke or other neurological or psychiatric disorder (other than FTD) that is considered the primary cause of behavioral symptoms.
Pregnancy or breastfeeding, or plan to become pregnant during the study period.
Use of any investigational or experimental drug or device within 60 days or 5 half-lives (whichever is longer) prior to screening.
Presence of speech or language impairment that severely affects the implementation of neuropsychological assessments or safety evaluations per the study protocol.
Trial design
Treatments tested in this trial
- Umbilical Cord Mesenchymal Stem Cell-Derived Exosomes （Low-Dose）
- Umbilical Cord Mesenchymal Stem Cell-Derived Exosomes （High-Dose）
- Placebo Comparator (0.9% NaCl)
Treatment groups
33 Participants
are divided into 3 treatment groupsLocations
Sponsors and collaborators
Ruijin Hospital
Lead sponsor
ECHO Biotech
Collaborator
Source ClinicalTrials.gov