Lung InjuryPhase 1/2NCT06416709
Stem Cell Treatment for Lung Injury Caused by Major Infectious Diseases
A Phase 1/2 study testing mesenchymal stem cells and saline in people with Lung Injury, run by Cell Energy Life Sciences Group Co. LTD at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Lung Injury
- What is being tested?
- mesenchymal stem cells and saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 10 May 2023to 10 May 2026
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing 302 Hospital
Beijing
Fu-Sheng Wang, Doctor, 8610-13671005510, fswang302@163.com
Fu-Sheng Wang, Doctor
About this study
Official title: To Study the Clinical Treatment Plan of Lung Injury Caused by Major Infectious Diseases Treated With Stem Cells
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.
Read the detailed description
For patients with lung injury caused by major infectious diseases, conventional antiviral and anti-inflammatory treatments may not effectively improve lung function in the short term and may increase the risk of secondary infections. Therefore, in the clinical management of viral pneumonia, it is necessary to consider the lung tissue damage caused by acute viral replication and systemic immune stress, while also focusing on the subsequent lung functional impairment due to virus clearance-induced pulmonary fibrosis. Studies have shown that after peripheral intravenous administration of mesenchymal stem cells (MSCs), approximately 50% to 60% of the cells remain in the lung tissue within 1 hour, decreasing to around 30% after 3 hours. After 48 hours, MSCs tend to aggregate in the liver and spleen, and cell retention can still be detected 10 days later. MSCs aggregation in the lung tissue can secrete cell trophic factors such as keratinocyte growth factor (KGF), vascular endothelial growth factor (VEGF), and hepatocyte growth factor (HGF), promoting the regeneration of type II alveolar epithelial cells, improving the pulmonary microenvironment, and facilitating the repair of the alveolar epithelial barrier after ARDS injury.This study is intended 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
- Being tested
- mesenchymal stem cells, saline
- Medical subject headings
- Lung Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mesenchymal stem cellsDrug
Also called KY-2023-2-6-2
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
salineOther
10 ml saline is used as placebo once every three days and for three times
| Study group | Role | What they receive |
|---|---|---|
| placebo control use saline | Placebo comparator | saline is used as placebo in the placebo comparator group Receives: 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. Receives: Drug: mesenchymal stem cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 48 weeks
High-resolution CT imaging
at week 2, evaluate high-resolution CT imaging changes in lung lesions and compare with baseline
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2024
- Study start10 May 2023
- Primary completion10 May 2026 (estimated)
- Study completion10 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cell Energy Life Sciences Group Co. LTD
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Beijing 302 Hospital
- Responsible party
- Sponsor
- Investigators
- Fu sheng Wang, Dr, Principal investigator, Beijing 302 Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06416709
- Sponsor's protocol ID
- KY-2023-2-6-2
- Status last verified
- May 2024
- First submitted
- 11 May 2024
- Last updated
- 16 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Study the Clinical Treatment Plan of Lung Injury Caused by Major Infectious Diseases Treated With Stem Cells
- ClinicalTrials.gov ID
- NCT06416709
- Acronym / sponsor ID
- KY-2023-2-6-2
- Conditions
- Lung Injury
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Cell Energy Life Sciences Group Co. LTDIndustry (pharma, biotech, devices)
- Collaborators
- Beijing 302 Hospital
- Study start
- 10 May 2023 (actual)
- Primary completion
- 10 May 2026 (estimated)
- Study completion
- 10 May 2026 (estimated)
- First posted
- 16 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
For patients with lung injury caused by major infectious diseases, conventional antiviral and anti-inflammatory treatments may not effectively improve lung function in the short term and may increase the risk of secondary infections. Therefore, in the clinical management of viral pneumonia, it is necessary to consider the lung tissue damage caused by acute viral replication and systemic immune stress, while also focusing on the subsequent lung functional impairment due to virus clearance-induced pulmonary fibrosis. Studies have shown that after peripheral intravenous administration of mesenchymal stem cells (MSCs), approximately 50% to 60% of the cells remain in the lung tissue within 1 hour, decreasing to around 30% after 3 hours. After 48 hours, MSCs tend to aggregate in the liver and spleen, and cell retention can still be detected 10 days later. MSCs aggregation in the lung tissue can secrete cell trophic factors such as keratinocyte growth factor (KGF), vascular endothelial growth factor (VEGF), and hepatocyte growth factor (HGF), promoting the regeneration of type II alveolar epithelial cells, improving the pulmonary microenvironment, and facilitating the repair of the alveolar epithelial barrier after ARDS injury.This study is intended 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| placebo control use saline | Placebo comparator | Other: salinesaline is used as placebo in the placebo comparator group |
| mesenchymal stem cells treatment | Experimental | Drug: mesenchymal stem cellsMesenchymal 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. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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;
Key exclusion criteria (9 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mesenchymal stem cellsAlso: KY-2023-2-6-2Mesenchymal 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 treatment |
| saline10 ml saline is used as placebo once every three days and for three times | Other | placebo control use saline |
Primary outcome
Number of participants with side effects in MSCs treatment groups
Time frame: 48 weeks
Investiagte the number of participants with treatment-related adverse events as assessed by CTCAE v4.0 after MSCs infusion.
High-resolution CT imaging
Time frame: 2 weeks
at week 2, evaluate high-resolution CT imaging changes in lung lesions and compare with baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fu sheng Wang, Dr principal investigator
Beijing 302 Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing mesenchymal stem cells and saline in people with Lung Injury, run by Cell Energy Life Sciences Group Co. LTD at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhe Xu, Dr (86 150 0111 1836, xuzhe302@139.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with side effects in MSCs treatment groups (time frame: 48 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2024.