NCT06598202 Exploring Nasal Drop Therapy With Small Extracellular Vesicles for ALS
| NCT ID | NCT06598202 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Xuanwu Hospital, Beijing |
| Condition | Amyotrophic Lateral Sclerosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 38 participants |
| Start Date | 2024-12-01 |
| Primary Completion | 2026-05-30 |
Trial Parameters
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Brief 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 Criteria
Inclusion Criteria: * Age: 18-80 years, inclusion of both genders; * Disease duration: ≥6 months and ≤2 years (counted from the onset of any ALS symptoms); * Subjects must meet the El Escorial revised criteria (2000) for the diagnosis of ALS, with a diagnosis of Definite ALS, Probable ALS, Probable laboratory-supported ALS, or Possible ALS; * A score of ≥2 on each item of the revised ALS Functional Rating Scale (ALSFRS-R), with a score of 4 for items related to dyspnea, orthopnea, and respiratory insufficiency; * BMI: Between 18 and 30 kg/m²; * Subjects must have a baseline forced vital capacity percentage (%FVC) ≥70%; * Allowed concomitant treatments: Oral administration of riluzole/edaravone at standard doses for ≥30 days; regular intravenous edaravone with planned sequential oral treatment. During the trial and follow-up period, the dosage and type of concomitant medications must remain unchanged; * Subjects of childbearing potential must use appropriate and effective contraception
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