Stem Cell Treatment for Lung Injury Caused by Major Infectious Diseases

NCT06416709 | Recruiting Phase 1 DMC

• 1 other identifier: KY-2023-2-6-2
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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

Lung Injury

Outcome Measures

Primary Outcomes (2)

• Number of participants with side effects in MSCs treatment groups

  Investiagte the number of participants with treatment-related adverse events as assessed by CTCAE v4.0 after MSCs infusion.

  48 weeks

• High-resolution CT imaging

  at week 2, evaluate high-resolution CT imaging changes in lung lesions and compare with baseline

  2 weeks

Study Arms (2)

placebo control use saline

PLACEBO COMPARATOR

saline is used as placebo in the placebo comparator group

Other: saline

mesenchymal stem cells treatment

EXPERIMENTAL

Mesenchymal stem cell dose is 5×10\*7/10ml and is transplanted by intravenous infusion. The cells are used once every three days and for three times.

Drug: mesenchymal stem cells

Interventions

mesenchymal stem cells DRUG

Mesenchymal stem cell dose is 5×10\*7/10ml and is transplanted by intravenous infusion. The cells are used once every three days and for three times

Also known as: KY-2023-2-6-2

mesenchymal stem cells treatment

saline OTHER

10 ml saline is used as placebo once every three days and for three times

placebo control use saline

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years old;
• 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;
• 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;
• Invasive mechanical ventilation and vasopressor medications were not required.

You may not qualify if:

• Patients tested active for HBV, HCV, HIV, or tuberculosis at the time of screening;
• patients with solid tumors, leukemia or mental disorders;
• 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;
• 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.
• Unwillingness to sign informed consent forms;
• Evidence of drug addiction within 6 months before trial entry;
• Patients who are currently enrolled in other clinical trials and may violate this treatment regimen and observation indicators;
• Unable or unwilling to provide informed consent or to comply with the study requirements;
• Other serious conditions that may preclude the clinical trial.

Sponsors & Collaborators

• Cell Energy Life Sciences Group Co. LTD: lead
• Beijing 302 Hospital: collaborator

Study Sites (1)

Beijing 302 Hospital

Beijing, China

RECRUITING

MeSH Terms

Conditions

Lung Injury

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Thoracic Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Fu sheng Wang, Dr

  Beijing 302 Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhe Xu, Dr

CONTACT

86 150 0111 1836; xuzhe302@139.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2024
• First Posted: May 16, 2024
• Study Start: May 10, 2023
• Primary Completion (Estimated): May 10, 2026
• Study Completion (Estimated): May 10, 2026
• Last Updated: May 16, 2024

Record last verified: 2024-05

Locations

CN (1)