Actively Recruiting
The Safety, Tolerability and Preliminary Efficacy of Derived Motor Neuron Progenitor Cells (XS228CN) in Subjects With Amyotrophic Lateral Sclerosis
Led by XellSmart Bio-Pharmaceutical (Suzhou) Co., Ltd. · Updated on 2025-11-21
12
Participants Needed
1
Research Sites
158 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
A Phase I Study to Assess the Safety, Tolerability and Preliminary Efficacy of Derived Motor Neuron Progenitor Cells (XS228CN) in Subjects with Amyotrophic Lateral Sclerosis
CONDITIONS
Official Title
The Safety, Tolerability and Preliminary Efficacy of Derived Motor Neuron Progenitor Cells (XS228CN) in Subjects With Amyotrophic Lateral Sclerosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 75 years inclusive
- Definite or probable ALS diagnosis according to revised EI Escorial criteria
- Baseline respiratory function (FVC) at least 70% of predicted value
- Agree to use effective non-drug contraception if capable of birth from consent until 6 months after trial ends
- Willing to participate and able to understand and sign informed consent form
You will not qualify if you...
- Signs or symptoms of neuromuscular weakness not clearly caused by ALS
- Body mass index (BMI) less than 18.5 kg/m2
- Primary lateral sclerosis with only upper motor neuron symptoms
- Significant psychiatric disorders affecting evaluation
- Neurological or muscular diseases like metabolic muscle diseases or myasthenia gravis
- Uncontrolled severe autoimmune diseases or arthritis
- Active infections requiring antibiotics, antivirals, or antifungals within 2 weeks before screening
- Active or treated pulmonary tuberculosis
- Severe pulmonary diseases affecting evaluation
- Poorly controlled high blood pressure
- Previous or current heart abnormalities
- History of cirrhosis, chronic hepatitis, or liver dysfunction
- History of chronic kidney disease
- History of bleeding or clotting disorders or ongoing anticoagulation treatment
- Active hepatitis B, hepatitis C, HIV, or syphilis infection at screening
- Recent severe trauma or surgery affecting assessment
- Contraindications to lumbar puncture such as injection site infection or high intracranial pressure
- Malignant tumor within 5 years or current antitumor therapy
- Participation in other clinical trials within 3 months prior to screening
- Pregnant or breastfeeding women
- Investigator judges participant unsuitable for trial
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Peking University Third Hospital
Beijing, Beijing Municipality, China, 100191
Actively Recruiting
Research Team
M
Michael LEE
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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