Actively Recruiting
Exploring Nasal Drop Therapy With Small Extracellular Vesicles for ALS
Led by Xuanwu Hospital, Beijing · Updated on 2024-10-31
38
Participants Needed
1
Research Sites
77 weeks
Total Duration
On this page
Sponsors
X
Xuanwu Hospital, Beijing
Lead Sponsor
S
Shengqi Medical Technology (Guangzhou) Co., Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Exploring Nasal Drop Therapy With Small Extracellular Vesicles for ALS
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 80 years, including all genders
- ALS disease duration between 6 months and 2 years from symptom onset
- Diagnosis meeting El Escorial revised criteria (Definite, Probable, Probable laboratory-supported, or Possible ALS)
- Score of 2 or higher on each item of the revised ALS Functional Rating Scale, with a score of 4 on items related to breathing difficulties
- Body mass index between 18 and 30 kg/m²
- Baseline forced vital capacity percentage of 70% or higher
- Stable oral riluzole or edaravone treatment for at least 30 days, or regular intravenous edaravone with planned oral treatment
- Use of effective contraception from 2 weeks before enrollment until end of follow-up for participants of childbearing potential
- Ability to provide informed consent and comply with study procedures
You will not qualify if you...
- Diagnosis other than ALS based on clinical and test evaluations
- Abnormal nasal anatomy or severe nasal disease affecting drug administration
- Need for nasal gastric tube insertion
- Low blood counts or abnormal liver function tests
- Severe kidney disease (glomerular filtration rate below 30 mL/min) or other serious kidney conditions
- Positive tests for hepatitis B, hepatitis C, syphilis, or HIV infections
- Recent heart attack or interventional heart treatment within 6 months, or severe heart failure
- Severe infections, immunodeficiency, or current use of immunosuppressant medications
- Other serious systemic diseases like coagulation disorders or cancer
- Recent vaccination within 1 month before or during the study
- Known allergy to study drugs or similar treatments
- Participation in another clinical trial with investigational drugs within the past 3 months
- Contraindications or inability to tolerate MRI
- Pregnant or breastfeeding women, or inability/unwillingness to use contraception if of childbearing potential
- Inability or unwillingness to follow study procedures
- Any other conditions making participation unsuitable per investigator judgment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Xuanwu Hospital ,Capital Medical University
Beijing, Beijing Municipality, China, 100053
Actively Recruiting
Research Team
J
Junwei Hao, MD; PhD
CONTACT
G
Gaoting Ma, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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