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Exploring Nasal Drop Therapy With Small Extracellular Vesicles for ALS

NCT06598202 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2024-10-31

No results posted yet for this study

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.

Conditions

Interventions

DRUG

exosomes 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).

DRUG

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

Exosomes placebo

Sponsors & Collaborators

  • Shengqi Medical Technology (Guangzhou) Co., Ltd.

    collaborator UNKNOWN

  • Viyun (Xiamen) Biomedical Research Institute Co., Ltd.

    collaborator UNKNOWN

  • Xuanwu Hospital, Beijing

    lead OTHER

Principal Investigators

  • Junwei Hao, MD; PhD · Xuanwu Hospital, Beijing

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-01
Primary Completion
2026-05-30
Completion
2026-05-30

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06598202 on ClinicalTrials.gov