hUC-MSC-sEV-001 Nasal Drops for Neurodegenerative Diseases
Condition(s) studied
Investigational drug(s) / intervention(s)
hUC-MSC-sEV-001 nasal drops: hUC-MSC-sEV-001 nasal drops
Study summary
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.
Eligibility
Primary outcome measure(s)
- Alzheimer's disease: Change in Alzheimer's disease assessment scale-cognitive section(ADAS-cog) — 12 months
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) — 12 months
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) — 12 months
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) — 12 months
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. - frontotemporal dementia: CDR Dementia Staging Instrument PLUS National Alzheimer's Coordinating Center Behavior and Language Domains(CDR+NACC FTLD) — 12 months
The CDR Dementia Staging Instrument provides a global assessment of cognitive and functional decline, while the NACC Behavior and Language Domains offer a more nuanced view of neuropsychiatric symptoms and language impairments. - Amyotrophic lateral sclerosis: Change in Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised (ALSFRS-R) — 6 months
The ALSFRS-R is rating scale (ratings 0 = can't do, to 4 = normal ability) used to determine participants' assessment of their capability and independence in 12 functional activities. This is a validated scale, both in person and by phone, which provides a total score from four sub-scores which assess speech and swallowing (bulbar function), use of upper extremities (cervical function), gait and turning in bed (lumbar function), and breathing (respiratory function). Total scores range from 0 (most impaired) to 48 (normal ability).
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Xuanwu Hospital, Capital Medical University | Beijing | Beijing Municipality |
More Xuanwu Hospital, Beijing trials in China
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06607900 on ClinicalTrials.gov ↗ ← All trials in China