To evaluate the safety and preliminary efficacy of human umbilical cord mesenchymal stem cell-derived small extracellular vesicles hUC-MSC-sEV-001 nasal drops in multiple neurodegenerative diseases, including Alzheimer's disease, Parkinson's disease, multiple system atrophy, Lewy body dementia, frontotemporal dementia, and amyotrophic lateral sclerosis.
Age 18-80 years (inclusive), any gender.
Subjects or their legal guardians voluntarily sign a written informed consent form and are able to comply with the study requirements for dosing and follow-up.
Subjects who have received allogeneic mesenchymal progenitor cell therapy or its derived small extracellular vesicles.
Subjects with abnormal nasal anatomy, nasal damage, severe rhinitis, or other nasal conditions that may affect the administration of the investigational product.
Subjects requiring nasogastric tube insertion.
Suffering from other uncontrolled diseases that may interfere with the study results, including but not limited to severe local infection, systemic infection, or immunodeficiency.
Single group
hUC-MSC-sEV-001 nasal drops
DrughUC-MSC-sEV-001 nasal drops
Alzheimer's disease: Change in Alzheimer's disease assessment scale-cognitive section（ADAS-cog）
ADAS-Cog is comprised of 11 modalities that evaluate memory, praxis, and language deficiencies. The total score range is 0 to 70 points, with higher scores indicating greater cognitive impairment.
Parkinson's disease: Change in MDS Unified-Parkinson Disease Rating Scale(MDS-UPDRS)
The MDS-UPDRS is defined by 4 Parts, each composed by a different number of items. The MDS-UPDRS has a minimum score of 0 and a maximum score of 260. The higher the score, the more severe the impairment.
multiple system atrophy: Unified Multiple System Atrophy Rating Scale（Part I and Part II）
UMSARS is a clinical tool designed to assess the severity and progression of MSA. The scale is divided into multiple parts, with Part I focusing on functional disability based on the history and self-report symptoms and Part II the severity of motor symptoms through a physical examination. The higher score, the severer impairment.
lewy body dementia: Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change (ADCS-CGIC)
ADCS-CGIC provides a clinician-rated, subjective evaluation of a patient\'s cognitive, behavioral, and functional performance based on interviews and observations. The scoring typically uses a 7-point scale. The lower score, the better changes in overall condition.
Barthel index
The Barthel Index is used for measuring a person\'s ability to perform basic activities of daily living.Scores typically range from 0 (totally dependent) to 100 (completely independent), with higher scores indicating greater independence in daily functioning.
mini mental status exam(MMSE)
The Mini-Mental State Examination (MMSE) is used for assessing cognitive function. The MMSE is scored out of a total of 30 points. A higher score indicates better cognitive function.
EQ-5D-5L
The EQ-5D-5L is used to measure health-related quality of life. The EQ-5D-5L assesses health on a scale of 0 to 25. A higher score means a lower quality of life.
Alzheimer's disease: sum of boxes of the CDR（CDR-SB）
The CDR-SB is used to assess the severity of cognitive impairment and dementia. The total score can range from 0 to 18, where higher scores indicate greater levels of impairment across the domains.
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