Stem cell treatment for lung injury from infections

To Study the Clinical Treatment Plan of Lung Injury Caused by Major Infectious Diseases Treated With Stem Cells

This study is testing whether stem cells can help people with lung injuries from infections, like viral pneumonia, feel better and breathe easier.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 80 (estimated)
• Ages: 18 Years to 90 Years
• Sex: All
• Sponsor: Cell Energy Life Sciences Group Co. LTD (Industry-sponsored)
• Drugs / interventions: immunotherapy
• Locations: 1 site (Beijing)
• Trial ID: NCT06416709 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the safety and effectiveness of mesenchymal stem cells (MSCs) in treating lung injuries caused by major infectious diseases, such as viral pneumonia. It will be a prospective, double-blind, randomized placebo-controlled trial, where participants will receive either MSCs or a saline placebo. The study focuses on the potential of MSCs to improve lung function by promoting the regeneration of lung tissue and reducing inflammation. By understanding how MSCs interact with lung tissue, the trial seeks to provide insights into new treatment options for patients with severe lung injuries.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older diagnosed with advanced viral pneumonia caused by specific infectious agents like SARS-CoV-2, adenovirus, or influenza virus.

Not a fit: Patients with mild lung injuries or those not diagnosed with viral pneumonia may not benefit from this treatment.

Why it matters

Potential benefit: If successful, this treatment could significantly improve lung function and recovery for patients suffering from severe lung injuries due to viral infections.

How similar studies have performed: While the use of MSCs in treating lung injuries is a novel approach, preliminary studies have shown promise in similar applications, indicating potential for success.

Eligibility criteria

Inclusion Criteria:

1. Age ≥18 years old;
2. Understand and sign the informed consent form, comply with the relevant requirements of this study, and agree not to participate in other studies and not to receive other immunotherapy during the study participation;
3. meet the diagnosis of viral pneumonia and are in the advanced stage of disease: (1)The etiological diagnosis met any of the following criteria:

   ①Sars-cov-2 infection: Respiratory specimens (nasal/throat swabs or bronchial secretions/bronchoalveolar lavage fluid) were positive for Sars-cov-2 nucleic acid and/or antigen within 14 days;

   ②Adenovirus infection: positive for adenovirus nucleic acid and/or antigen in respiratory secretions or blood within 14 days;

   ③Influenza virus infection: positive respiratory secretions or blood for influenza virus nucleic acid and/or antigen within 14 days;

   ④Other respiratory virus antigens or nucleic acids were positive in respiratory secretions or blood within 14 days; (2)Imaging manifestations: chest X-ray or CT was consistent with the imaging features of viral pneumonia, manifested as multiple patchy shadows, ground glass shadows or consolidation in both lungs; (3)Respiratory System Indicators:Respiratory distress, respiratory rate (RR) ≥30 breaths/min at rest; In the resting state, oxygen saturation of finger pulse was ≤93% while breathing air; Oxygen and index (partial pressure of arterial oxygen/fraction of inspired oxygen) ≤300mmHg and \> 200mmHg;
4. Invasive mechanical ventilation and vasopressor medications were not required.

Exclusion Criteria:

1. Patients tested active for HBV, HCV, HIV, or tuberculosis at the time of screening;
2. patients with solid tumors, leukemia or mental disorders;
3. The peripheral white blood cell count was still more than 12×109/L or less than 4×109/L after effective anti-infective treatment. Plasma C-reactive protein \>2 times the upper limit of normal; Plasma procalcitonin \>2 times the upper limit of normal;
4. There were severe complications or major organ complications: severe cardiovascular and cerebrovascular diseases: acute heart failure NYHAⅢ; uncontrolled myocarditis or valvular disease; malignant arrhythmia; incident (≤6 months) cardio-cerebrovascular events (myocardial infarction or stroke); previous chronic bronchitis, severe asthma, obstructive pulmonary emphysema, pulmonary fibrosis, and other diseases that require long-term oxygen therapy or affect daily activities; patients with acute renal failure (≥44.2 μmol/L daily increase in serum creatinine) or chronic renal insufficiency had serum creatinine ≥442 μmol/L; the liver function was markedly abnormal and ALT≥5×ULN; serum TBil≥10×ULN or daily increase ≥17.1 μmol/L; signs of bleeding, PTA≤ 40% (or INR≥1.5); severe anemia (Hb\<60g/L), moderate or severe thrombocytopenia (PLT\<60×109/L), and DIC; other conditions that the investigators thought might affect treatment effectiveness.
5. Unwillingness to sign informed consent forms;
6. Evidence of drug addiction within 6 months before trial entry;
7. Patients who are currently enrolled in other clinical trials and may violate this treatment regimen and observation indicators;
8. Unable or unwilling to provide informed consent or to comply with the study requirements;
9. Other serious conditions that may preclude the clinical trial.

Where this trial is running

Beijing

• Beijing 302 Hospital — Beijing, China (Recruiting)

Study contacts

• Principal investigator: Fu sheng Wang, Dr — Beijing 302 Hospital
• Study coordinator: Zhe Xu, Dr

Conditions Lung Injury