RecruitingPhase 1Phase 2NCT06598202

Exploring Nasal Drop Therapy With Small Extracellular Vesicles for ALS

An Exploratory Study on the Use of Intranasal Administration of Small Extracellular Vesicles for the Treatment of Amyotrophic Lateral Sclerosis

Sponsor

Xuanwu Hospital, Beijing

Enrollment

38 participants

Start Date

Dec 1, 2024

Study Type

INTERVENTIONAL

Conditions

Amyotrophic Lateral Sclerosis

Summary

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.

Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called a placebo of exosomes derived from human umbilical cord blood mesenchymal stem cells for nasal drop and a drug called exosomes derived from human umbilical cord blood mesenchymal stem cells for nasal drop for people with amyotrophic lateral sclerosis. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years to 80 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGexosomes derived from human umbilical cord blood mesenchymal stem cells for nasal drop

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).

DRUGa placebo of exosomes derived from human umbilical cord blood mesenchymal stem cells for nasal drop

Exosomes placebo

Locations(1)

Xuanwu Hospital ,Capital Medical University

Beijing, Beijing Municipality, China

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NCT06598202

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