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

Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-80
SponsorXuanwu Hospital, Beijing

About this trial

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 criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • hUC-MSC-sEV-001 nasal drops

Treatment groups

120 Participants
are divided into 1 treatment group

Sponsors and collaborators