Exploring Nasal Drop Therapy With Small Extracellular Vesicles for ALS

Sponsor
Xuanwu Hospital, Beijing
Study ID
NCT06598202
Phase
PHASE1/PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • exosomes derived from human umbilical cord blood mesenchymal stem cells for nasal drop — DRUG
    Exosomes derived from human umbilical cord blood mesenchymal stem cells for nasal drop (administered once daily, twice a week, for a total of two weeks, based on the recommended dose during the dose-escalation phase).
  • a placebo of exosomes derived from human umbilical cord blood mesenchymal stem cells for nasal drop — DRUG
    Exosomes placebo

Study Details

This is a multicenter, randomized, double-blind, placebo-controlled, dose-escalation trial. The goal of this clinical trial is to evaluate the safety and preliminary efficacy of nasal drop exosomes derived from human umbilical cord blood mesenchymal stem cells (hUC-MSC-sEV-001) in amyotrophic lateral sclerosis.

Key Dates

First listed
Sep 19, 2024
Start date
Dec 1, 2024
Status verified
Oct 2024
Primary completion
May 30, 2026
Completion
May 30, 2026

Study Design

Enrollment
38 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Exosomes group
    Patients in this arm will receive exosomes derived from human umbilical cord blood mesenchymal stem cells as a nasal drop, administered once daily, twice a week, for a total of two weeks.
  • Placebo Comparator: Exosomes placebo group
    Patients in this arm will receive a placebo nasal drop mimicking exosomes derived from human umbilical cord blood mesenchymal stem cells, administered once daily, twice a week, for a total of two weeks.

Primary Outcome Measure

Number of participants who experienced dose-limiting Toxicities (DLTs) [ Time Frame: 24 hours, 4±1 Weeks ]

Central Contacts

Related Studies