Acute Respiratory Distress Syndrome (ARDS)Phase 1CGBM1-ARDS-I01NCT07892950
Clinical Trial of CG-BM1 Allogeneic Human Bone Marrow Mesenchymal Stem Cell Injection in the Treatment of Acute Respiratory Distress Syndrome
A Phase 1 study testing CG-BM1 in people with Acute Respiratory Distress Syndrome (ARDS), run by GuangZhou Cellgenes Biotechnology Co., Ltd. at 1 site in China.
Trial summary
1. To evaluate the safety and tolerability of CG-BM1 for the treatment of patients with Acute Respiratory Distress Syndrome. 2. To observe the preliminary effectiveness of CG-BM1 in treating Acute Respiratory Distress Syndrome patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Respiratory Distress Syndrome (ARDS)
- What is being tested?
- CG-BM1
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteChina
- Study dates
- 4 Jan 2023to 20 Dec 2025
- Phase
- Phase 1
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years; male or female.
- Currently receiving mechanical ventilation; confirmed or clinically diagnosed infection-induced moderate-to-severe ARDS; diagnosis of moderate-to-severe ARDS meets the 2012 Berlin Definition.
- No improvement in moderate-to-severe ARDS after 24 hours of conventional clinical treatment. No improvement is defined as PaO2/FiO2 remaining ≤200 mmHg after 24 hours of the above conventional conservative treatment, or from a value above 200 mmHg to ≤200 mmHg; for severe ARDS, this period may be shortened to 8 hours.
- No possibility of conception (or impregnating a sexual partner), childbearing, or breastfeeding during the study period and for 6 months after cell infusion.
Who cannot join
- More than 7 days since first meeting ARDS criteria (2012 Berlin Definition) at enrollment.
- Pregnancy or breastfeeding.
- History of malignancy requiring treatment within the past 2 years or malignancy requiring treatment at screening.
- At screening, grade 3 or 4 pulmonary hypertension or severe chronic respiratory disease with PaCO2 >50 mmHg; history of severe end-stage lung disease.
- At screening, large pleural effusion or atelectasis that is not promptly resolved or rapidly recurs after resolution (chest X-ray showing >50% unilateral lung atelectasis).
- At screening, severe cardiopulmonary malformation affecting cardiopulmonary function.
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- Prior lung transplantation.
- Deep vein thrombosis at screening or history of pulmonary embolism within 3 months before screening.
- Transfusion-related adverse reaction within 4 weeks before admission.
- Active bleeding within the past 24 hours requiring massive transfusion support.
- Cardiac arrest within 4 weeks before admission.
- Positive HIV antibody or positive Treponema pallidum antibody at screening.
- Hepatic failure at screening (MELD score >30).
- Long-term hemodialysis, known severe renal impairment (estimated glomerular filtration rate <30 mL/min/1.73 m2), or current use of extracorporeal membrane oxygenation (ECMO).
- Severe cerebral herniation at screening.
- Expected survival <24 hours.
- Invasive blood pressure and central venous pressure are not monitored or not planned to be monitored.
- Participation in another interventional clinical trial within 3 months or 5 half-lives before infusion.
- Any other factor that, in the investigator's judgment, makes the participant unsuitable for this trial.
- . Known hypersensitivity to any component of the study drug (the main component is bone marrow mesenchymal stem cells; excipients include dimethyl sulfoxide, human serum albumin,etc.).
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou
About this study
Official title: A Phase 1 Clinical Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of Allogeneic Human Bone Marrow Mesenchymal Stem Cell (CG-BM1) Injection in the Treatment of Moderate-to-Severe Acute Respiratory Distress Syndrome in Adults
- To evaluate the safety and tolerability of CG-BM1 for the treatment of patients with Acute Respiratory Distress Syndrome.
- To observe the preliminary effectiveness of CG-BM1 in treating Acute Respiratory Distress Syndrome patients.
- Being tested
- CG-BM1
- Medical subject headings
- Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CG-BM1Biological
CG-BM1 is administered as a single dose of 1.0 × 10^6 cells/kg.
CG-BM1Biological
CG-BM1 is administered as a single dose of 2.0 × 10^6 cells/kg.
CG-BM1Biological
CG-BM1 is administered as a single dose of 5.0 × 10^6 cells/kg.
| Study group | Role | What they receive |
|---|---|---|
| CG-BM1- 1.0 × 10^6 cells/kg | Experimental | Administration procedure of CG-BM1: 1.0 × 10^6 cells/kg as a single administration. Conventional treatment includes, but is not limited to: infection control; respiratory support (e.g., lung-protective ventilation, lung recruitment maneuvers, prone positioning); conservative fluid therapy; hemodynamic management (e.g., vasoactive agents, inotropic agents); corticosteroids; nutritional support; and prevention of complications. Receives: Biological: CG-BM1 |
| CG-BM1- 2.0 × 10^6cells/kg | Experimental | Administration procedure of CG-BM1: 2.0 × 10^6 cells/kg as a single administration. Conventional treatment includes, but is not limited to: infection control; respiratory support (e.g., lung-protective ventilation, lung recruitment maneuvers, prone positioning); conservative fluid therapy; hemodynamic management (e.g., vasoactive agents, inotropic agents); corticosteroids; nutritiona support; and prevention of complications. Receives: Biological: CG-BM1 |
| CG-BM1- 5.0 × 10^6cells/kg | Experimental | Administration procedure of CG-BM1: 5.0 × 10^6 cells/kg as a single administration. Conventional treatment includes, but is not limited to: infection control; respiratory support (e.g., lung-protective ventilation, lung recruitment maneuvers, prone positioning); conservative fluid therapy; hemodynamic management (e.g., vasoactive agents, inotropic agents); corticosteroids; nutritiona support; and prevention of complications. Receives: Biological: CG-BM1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of DLT.
Measured: 14 days after administration
Incidence of CG-BM1-related AEs and SAEs .
Measured: 6 months after administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2026
- Study start4 Jan 2023
- Primary completion20 Jun 2024
- Study completion20 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Respiratory Distress Syndrome (ARDS)Studies 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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- GuangZhou Cellgenes Biotechnology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07892950
- Sponsor's protocol ID
- CGBM1-ARDS-I01
- Acronym
- CGBM1-ARDS-I01
- Status last verified
- Oct 2026
- First submitted
- 19 Oct 2026
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Clinical Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of Allogeneic Human Bone Marrow Mesenchymal Stem Cell (CG-BM1) Injection in the Treatment of Moderate-to-Severe Acute Respiratory Distress Syndrome in Adults
- ClinicalTrials.gov ID
- NCT07892950
- Acronym / sponsor ID
- CGBM1-ARDS-I01 / CGBM1-ARDS-I01
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- GuangZhou Cellgenes Biotechnology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 4 Jan 2023 (actual)
- Primary completion
- 20 Jun 2024 (actual)
- Study completion
- 20 Dec 2025 (actual)
- First posted
- 23 Oct 2026 (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.
- To evaluate the safety and tolerability of CG-BM1 for the treatment of patients with Acute Respiratory Distress Syndrome.
- To observe the preliminary effectiveness of CG-BM1 in treating Acute Respiratory Distress Syndrome patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CG-BM1- 1.0 × 10^6 cells/kg | Experimental | Biological: CG-BM1Administration procedure of CG-BM1: 1.0 × 10^6 cells/kg as a single administration. Conventional treatment includes, but is not limited to: infection control; respiratory support (e.g., lung-protective ventilation, lung recruitment maneuvers, prone positioning); conservative fluid therapy; hemodynamic management (e.g., vasoactive agents, inotropic agents); corticosteroids; nutritional support; and prevention of complications. |
| CG-BM1- 2.0 × 10^6cells/kg | Experimental | Biological: CG-BM1Administration procedure of CG-BM1: 2.0 × 10^6 cells/kg as a single administration. Conventional treatment includes, but is not limited to: infection control; respiratory support (e.g., lung-protective ventilation, lung recruitment maneuvers, prone positioning); conservative fluid therapy; hemodynamic management (e.g., vasoactive agents, inotropic agents); corticosteroids; nutritiona support; and prevention of complications. |
| CG-BM1- 5.0 × 10^6cells/kg | Experimental | Biological: CG-BM1Administration procedure of CG-BM1: 5.0 × 10^6 cells/kg as a single administration. Conventional treatment includes, but is not limited to: infection control; respiratory support (e.g., lung-protective ventilation, lung recruitment maneuvers, prone positioning); conservative fluid therapy; hemodynamic management (e.g., vasoactive agents, inotropic agents); corticosteroids; nutritiona support; and prevention of complications. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥18 years; male or female.
- Currently receiving mechanical ventilation; confirmed or clinically diagnosed infection-induced moderate-to-severe ARDS; diagnosis of moderate-to-severe ARDS meets the 2012 Berlin Definition.
- No improvement in moderate-to-severe ARDS after 24 hours of conventional clinical treatment. No improvement is defined as PaO2/FiO2 remaining ≤200 mmHg after 24 hours of the above conventional conservative treatment, or from a value above 200 mmHg to ≤200 mmHg; for severe ARDS, this period may be shortened to 8 hours.
- No possibility of conception (or impregnating a sexual partner), childbearing, or breastfeeding during the study period and for 6 months after cell infusion.
Key exclusion criteria (20 listed)
- More than 7 days since first meeting ARDS criteria (2012 Berlin Definition) at enrollment.
- Pregnancy or breastfeeding.
- History of malignancy requiring treatment within the past 2 years or malignancy requiring treatment at screening.
- At screening, grade 3 or 4 pulmonary hypertension or severe chronic respiratory disease with PaCO2 >50 mmHg; history of severe end-stage lung disease.
- At screening, large pleural effusion or atelectasis that is not promptly resolved or rapidly recurs after resolution (chest X-ray showing >50% unilateral lung atelectasis).
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 |
|---|---|---|
| CG-BM1CG-BM1 is administered as a single dose of 1.0 × 10^6 cells/kg. | Biological | CG-BM1- 1.0 × 10^6 cells/kg |
| CG-BM1CG-BM1 is administered as a single dose of 2.0 × 10^6 cells/kg. | Biological | CG-BM1- 2.0 × 10^6cells/kg |
| CG-BM1CG-BM1 is administered as a single dose of 5.0 × 10^6 cells/kg. | Biological | CG-BM1- 5.0 × 10^6cells/kg |
Primary outcome
Incidence of DLT.
Time frame: 14 days after administration
Incidence of CG-BM1-related AEs and SAEs .
Time frame: 6 months after administration
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CG-BM1 in people with Acute Respiratory Distress Syndrome (ARDS), run by GuangZhou Cellgenes Biotechnology 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 4 inclusion and 20 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: finished, as of the sponsor's last update on 26 Oct 2026. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of DLT. (time frame: 14 days after administration). 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 26 Oct 2026.