Status:
NOT_YET_RECRUITING
hUC-MSC-sEV-001 Nasal Drops for Neurodegenerative Diseases
Lead Sponsor:
Xuanwu Hospital, Beijing
Conditions:
Alzheimer Disease
Parkinson Disease
Eligibility:
All Genders
18-80 years
Phase:
PHASE1
Brief 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, i...
Eligibility Criteria
Inclusion
- General 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
- 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).
- 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.
- Contraindications to MRI examination (e.g., metal implants) or inability to tolerate MRI (e.g., claustrophobia).
- Women of childbearing potential not intending to use effective contraception during the trial or within 90 days after the last dose and with a positive pregnancy test record; pregnant or lactating women; men who are sexually active during the trial or within 90 days after the last dose and not intending to use effective contraception; or men planning to donate sperm during the trial or within 90 days after the last dose.
- Vaccination within 1 month prior to the first dose or planned during the period from enrollment until the end of follow-up.
- Participation in other clinical drug studies within the past 30 days.
- Any condition that, in the investigator's judgment, may compromise the subject's ability to understand and/or comply with the study procedures and/or follow-up.
- Alzheimer's Disease (AD) Specific Criteria:
- Inclusion Criteria:
- Probable AD as defined by the 2011 National Institute on Aging-Alzheimer's Association (NIA-AA) criteria.
- Clinical Dementia Rating (CDR) score ≤ 1.0.
- Subjects have an identified, reliable caregiver.
- Stable treatment regimen for at least 1 month prior to dosing.
Key Trial Info
Start Date :
July 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 31 2028
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT06607900
Start Date
July 1 2025
End Date
August 31 2028
Last Update
July 8 2025
Active Locations (1)
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1
Xuanwu Hospital, Capital Medical University
Beijing, Beijing Municipality, China, 100053