Not Yet RecruitingPhase 1

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 range18 Years – 80 Years

SexALL

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.
✕. 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).

What they're measuring

Alzheimer's disease: Change in Alzheimer's disease assessment scale-cognitive section（ADAS-cog）

Timeframe: 12 months

Parkinson's disease: Change in MDS Unified-Parkinson Disease Rating Scale(MDS-UPDRS)

Timeframe: 12 months

multiple system atrophy: Unified Multiple System Atrophy Rating Scale（Part I and Part II）

Timeframe: 12 months

lewy body dementia: Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change (ADCS-CGIC)

Timeframe: 12 months

frontotemporal dementia: CDR Dementia Staging Instrument PLUS National Alzheimer's Coordinating Center Behavior and Language Domains（CDR+NACC FTLD）

Timeframe: 12 months

Amyotrophic lateral sclerosis: Change in Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised (ALSFRS-R)

Timeframe: 6 months

Trial details

NCT IDNCT06607900

SponsorXuanwu Hospital, Beijing

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-08-31

Contact for this trial

Junwei Hao, MD;PhD

86-01-83198277 haojunwei@vip.163.com

View on ClinicalTrials.gov More Alzheimer Disease trials

Plain-language summary

Who can participate

Age range18 Years – 80 Years

SexALL

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.
✕. 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).

What they're measuring

Alzheimer's disease: Change in Alzheimer's disease assessment scale-cognitive section（ADAS-cog）

Timeframe: 12 months

Parkinson's disease: Change in MDS Unified-Parkinson Disease Rating Scale(MDS-UPDRS)

Timeframe: 12 months

multiple system atrophy: Unified Multiple System Atrophy Rating Scale（Part I and Part II）

Timeframe: 12 months

lewy body dementia: Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change (ADCS-CGIC)

Timeframe: 12 months

frontotemporal dementia: CDR Dementia Staging Instrument PLUS National Alzheimer's Coordinating Center Behavior and Language Domains（CDR+NACC FTLD）

Timeframe: 12 months

Amyotrophic lateral sclerosis: Change in Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised (ALSFRS-R)

Timeframe: 6 months