hUC-MSC-sEV-001 Nasal Drops for Neurodegenerative Diseases
China120 participantsStarted 2025-07-01
Plain-language 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.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
Exclusion criteria
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Alzheimer's disease: Change in Alzheimer's disease assessment scale-cognitive section（ADAS-cog）
Timeframe: 12 months
2
Parkinson's disease: Change in MDS Unified-Parkinson Disease Rating Scale(MDS-UPDRS)
Timeframe: 12 months
3
multiple system atrophy: Unified Multiple System Atrophy Rating Scale（Part I and Part II）
Timeframe: 12 months
4
lewy body dementia: Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change (ADCS-CGIC)
Timeframe: 12 months
5
frontotemporal dementia: CDR Dementia Staging Instrument PLUS National Alzheimer's Coordinating Center Behavior and Language Domains（CDR+NACC FTLD）
. Suffering from other uncontrolled diseases that may interfere with the study results, including but not limited to severe local infection, systemic infection, or immunodeficiency.
. Combined with malignant tumors, hematological malignancies, or other serious systemic diseases.
. Clinically significant history of allergic reactions, especially drug allergic reactions.
. Severe renal insufficiency: creatinine clearance (CrCl) \< 30 mL/min (calculated by Cockcroft-Gault formula), or other known severe renal diseases.
. Peripheral blood hemoglobin (HGB) \< 100 g/L, absolute neutrophil count (NEUT) \< 1.5 × 10⁹/L, platelet count (PLT) \< 100 × 10⁹/L, white blood cell count (WBC) \< 4.0 × 10⁹/L or ≥ 12 × 10⁹/L, serum albumin \< 30 g/L; alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≥ 3 × upper limit of normal (ULN).