Actively Recruiting
Stem Cell Treatment for Lung Injury Caused by Major Infectious Diseases
Led by Cell Energy Life Sciences Group Co. LTD · Updated on 2024-05-16
80
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
Sponsors
C
Cell Energy Life Sciences Group Co. LTD
Lead Sponsor
B
Beijing 302 Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
The goal of this study is to conduct a prospective, double-blind, randomized placebo-controlled clinical trial to investigate the safety and efficacy of mesenchymal stem cells treatment for Lung injury caused by major infectious diseases.
CONDITIONS
Official Title
Stem Cell Treatment for Lung Injury Caused by Major Infectious Diseases
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Understand and sign the informed consent form, agree to comply with study requirements, not participate in other studies, and not receive other immunotherapy during the study
- Diagnosed with viral pneumonia in advanced stage with positive tests for Sars-cov-2, adenovirus, influenza virus, or other respiratory viruses within 14 days
- Chest X-ray or CT showing multiple patchy shadows, ground glass shadows, or consolidation in both lungs consistent with viral pneumonia
- Respiratory distress with respiratory rate 30 breaths/min or higher at rest
- Oxygen saturation 93% or lower on room air at rest
- Oxygenation index (PaO2/FiO2) between 200 mmHg and 300 mmHg
- Not requiring invasive mechanical ventilation or vasopressor medications
You will not qualify if you...
- Active infection with HBV, HCV, HIV, or tuberculosis at screening
- Diagnosis of solid tumors, leukemia, or mental disorders
- Peripheral white blood cell count greater than 12×10^9/L or less than 4×10^9/L after anti-infective treatment
- Plasma C-reactive protein or procalcitonin more than twice the upper limit of normal
- Severe cardiovascular or cerebrovascular diseases, including acute heart failure NYHA II, uncontrolled myocarditis or valvular disease, malignant arrhythmia, recent myocardial infarction or stroke
- Chronic lung diseases requiring long-term oxygen therapy or affecting daily activities
- Acute renal failure or chronic renal insufficiency with serum creatinine above 442 µmol/L
- Markedly abnormal liver function with ALT 5 times upper limit of normal or serum total bilirubin 10 times upper limit of normal
- Signs of bleeding with PTA ≤ 40% or INR ≥ 1.5
- Severe anemia (hemoglobin <60 g/L), moderate or severe thrombocytopenia (platelets <60×10^9/L), or disseminated intravascular coagulation
- Unwillingness to sign informed consent
- Evidence of drug addiction within 6 months before trial entry
- Enrollment in other clinical trials that may interfere with this study
- Unable or unwilling to provide informed consent or comply with study requirements
- Other serious conditions that may affect treatment effectiveness
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Beijing 302 Hospital
Beijing, China
Actively Recruiting
Research Team
Z
Zhe Xu, Dr
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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