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hUC-MSC-sEV-001 Nasal Drops for Neurodegenerative Diseases | Clinical Trials | Clareo Health

NOT_YET_RECRUITINGPHASE1

hUC-MSC-sEV-001 Nasal Drops for Neurodegenerative Diseases

A Multi-center, Open, Single-arm, Basket-design Clinical Trial to Evaluate the Safety and Efficacy of Human Umbilical Cord Mesenchymal Stem Cell-derived Small Extracellular Vesicles hUC-MSC-sEV-001 Nasal Drops for the Treatment of Multiple Neurodegenerative Diseases

NCT06607900•Xuanwu Hospital, Beijing

View on ClinicalTrials.gov

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

Age

18 - 80 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•General Criteria:
•1. Age 18-80 years (inclusive), any gender.
•2. 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.
•1. Probable AD as defined by the 2011 National Institute on Aging-Alzheimer's Association (NIA-AA) criteria.
•2. Clinical Dementia Rating (CDR) score ≤ 1.0.
•3. Subjects have an identified, reliable caregiver.
•4. Stable treatment regimen for at least 1 month prior to dosing.
•1. Diagnosis of PD according to the 2015 Movement Disorder Society (MDS) clinical diagnostic criteria for PD.
•2. Hoehn and Yahr stage ≤ 3.
•3. Stable treatment regimen for at least 1 month prior to dosing.
+14 more criteria

Exclusion Criteria

•1. Subjects who have received allogeneic mesenchymal progenitor cell therapy or its derived small extracellular vesicles.
•2. Subjects with abnormal nasal anatomy, nasal damage, severe rhinitis, or other nasal conditions that may affect the administration of the investigational product.
•3. Subjects requiring nasogastric tube insertion.
•4. Suffering from other uncontrolled diseases that may interfere with the study results, including but not limited to severe local infection, systemic infection, or immunodeficiency.
•5. Combined with malignant tumors, hematological malignancies, or other serious systemic diseases.
•6. Clinically significant history of allergic reactions, especially drug allergic reactions.
•7. Severe renal insufficiency: creatinine clearance (CrCl) \< 30 mL/min (calculated by Cockcroft-Gault formula), or other known severe renal diseases.
•8. 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).
•9. HBsAg positive, or HBcAb positive with HBV DNA positive, hepatitis C virus (HCV) antibody positive, peripheral blood HCV RNA positive, HIV antibody positive; CMV DNA positive, syphilis serology positive.
•10. Contraindications to MRI examination (e.g., metal implants) or inability to tolerate MRI (e.g., claustrophobia).
+19 more criteria

Locations (1)

Xuanwu Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Key Dates

Start Date

July 1, 2025

Primary Completion Date

August 31, 2027

Completion Date

August 31, 2028

Last Updated

July 8, 2025

Enrollment

120

ESTIMATED participants

Conditions

Alzheimer DiseaseParkinson DiseaseLewy Body DementiaMultiple System AtrophyFronto-temporal DementiaAmyotrophic Lateral Sclerosis

Interventions

hUC-MSC-sEV-001 nasal drops

DRUG

Contacts

Junwei Hao, MD;PhD

CONTACT

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

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 8, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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