Acute Respiratory Distress SyndromePhase 1/2ARDSNCT07413978
A Clinical Trial of Human Umbilical Cord Mesenchymal Stem Cell Injection for the Treatment of Severe Acute Respiratory Distress Syndrome
A Phase 1/2 study testing 1 vial containing a total of 5×10^7 cells, 2 vial containing a total of 1×10^8 cells and 3 vial containing a total of 1.5×10^8 cells in people with Acute Respiratory Distress Syndrome, run by Changchun Tuohua Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
Primary Objective: To evaluate the safety and tolerability of human umbilical cord mesenchymal stem cell injection in the treatment of moderate/severe acute respiratory distress syndrome.Secondary Objectives: To explore the efficacy and appropriate dosage of human umbilical cord mesenchymal stem cell injection in the… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Acute Respiratory Distress Syndrome
- What is being tested?
- 1 vial containing a total of 5×10^7 cells, 2 vial containing a total of 1×10^8 cells and 3 vial containing a total of 1.5×10^8 cells
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteChina
- Study dates
- 25 Apr 2025to 31 Dec 2028
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female patients aged 18 to 80 years (inclusive).
- Diagnosis of moderate or severe Acute Respiratory Distress Syndrome (ARDS) according to A New Global Definition of Acute Respiratory Distress Syndrome, with an infectious etiology.
- No improvement after 24 hours of conventional clinical treatment (defined as a persistent PaO₂/FiO₂ ratio ≤200 mmHg or a decrease from >200 mmHg to ≤200 mmHg after 24 hours of conventional supportive therapy; for severe ARDS, this assessment period may be shortened to 8 hours).
- Ability to fully understand the nature of the study and voluntarily provide written informed consent.
- Willingness to comply with all study procedures and demonstrate good compliance during the study period.
- Agreement to participate in long-term follow-up.
Who cannot join
- Patients with ARDS caused by COVID-19 infection.
- Patients currently suffering from hepatitis B, hepatitis C, active or latent tuberculosis, AIDS, syphilis, immunodeficiency disorders, or other immune system diseases.
- Presence of severe cardiovascular diseases at screening, including:Cardiac function classification of NYHA class III or higher.Uncontrolled myocarditis or valvular disease.Malignant arrhythmia requiring pharmacological treatment.
- Abnormal liver or renal function at screening meeting any of the following criteria:ALT or AST ≥ 5 × ULN, or total bilirubin ≥ 3 × ULN.Serum creatinine ≥ 3 × ULN, or patients currently undergoing renal replacement therapy (CRRT).
- Patients receiving extracorporeal membrane oxygenation (ECMO) therapy at the time of screening.
- Severe hematological abnormalities at screening, including: hemorrhagic manifestations, PTA ≤ 40% (or INR ≥ 2.0), severe anemia (Hb < 60 g/L), moderate or severe thrombocytopenia (PLT < 50 × 10^9/L), disseminated intravascular coagulation (DIC), leukemia, or other hematological abnormalities deemed ineligible for the study.
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- Severe end-stage respiratory diseases at screening.
- Pulmonary hypertension with a pulmonary artery pressure > 70 mmHg.
- History of deep vein thrombosis or pulmonary embolism within the 6 months prior to enrollment.
- Patients post lung transplantation.
- Presence of severe cardiopulmonary malformations at screening.
- Severe psychiatric disorders.
- Patients who are pregnant (positive pregnancy test), breastfeeding, or have a pregnancy plan, are unwilling to practice contraception during the study and for 12 months after the infusion, or are of childbearing potential and unwilling to use effective contraception.
- Use of high-dose corticosteroids equivalent to methylprednisolone > 240 mg/day within 3 days prior to enrollment, or long-term irregular use of systemic corticosteroids for other diseases, which, in the investigator's judgment, may affect efficacy evaluation.
- Allergy to any component of the Human Umbilical Cord Mesenchymal Stem Cell Injection (e.g., human albumin), or a history of severe allergies deemed by the investigator as unsuitable for participation.
- Concurrent participation in another interventional clinical trial, or participation in another interventional clinical trial within the 3 months prior to screening.
- History or current diagnosis of malignancy, or pathological confirmation of precancerous lesions.
- Any other condition that, in the investigator's judgment, would lead to premature termination of the study, such as non-adherence to the protocol, concurrent severe illnesses requiring combined treatment, significant laboratory abnormalities, or social/family factors that could compromise the patient's safety or data collection.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Zhongnan Hospital of Wuhan University
Wuhan, Hubei
Zhiyong Peng, +8627-67811807, pengzy5@hotmail.com
About this study
Official title: A Phase I-II, Open-label, Single-arm, Dose-escalation Clinical Trial to Evaluate the Safety and Tolerability of Human Umbilical Cord Mesenchymal Stem Cell Injection in the Treatment of Moderate to Severe Acute Respiratory Distress Syndrome
Primary Objective: To evaluate the safety and tolerability of human umbilical cord mesenchymal stem cell injection in the treatment of moderate/severe acute respiratory distress syndrome.Secondary Objectives: To explore the efficacy and appropriate dosage of human umbilical cord mesenchymal stem cell injection in the treatment of moderate/severe acute respiratory distress syndrome.Exploratory Objective: To explore the immunogenicity and pharmacokinetic/pharmacodynamic (PK/PD) characteristics of a single dose of human umbilical cord mesenchymal stem cell injection in patients with moderate/severe acute respiratory distress syndrome.
- Conditions
- Acute Respiratory Distress Syndrome
- Being tested
- 1 vial containing a total of 5×10^7 cells, 2 vial containing a total of 1×10^8 cells, 3 vial containing a total of 1.5×10^8 cells, 4 vial containing a total of 2×10^8 cells
- Keywords
- Acute respiratory distress syndrome, ARDS, Human Umbilical Cord Mesenchymal Stem Cells
- 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.
1 vial containing a total of 5×10^7 cellsBiological
venous reinfusion
2 vial containing a total of 1×10^8 cellsBiological
venous reinfusion
3 vial containing a total of 1.5×10^8 cellsBiological
venous reinfusion
4 vial containing a total of 2×10^8 cellsBiological
venous reinfusion
| Study group | Role | What they receive |
|---|---|---|
| Human Umbilical Cord Mesenchymal Stem Cells Injection | Experimental | single-dose Receives: Biological: 1 vial containing a total of 5×10^7 cells; Biological: 2 vial containing a total of 1×10^8 cells; Biological: 3 vial containing a total of 1.5×10^8 cells; Biological: 4 vial containing a total of 2×10^8 cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
DLT incidence rate
Safety Indicator
Measured: within 28 days after administration
Maximum Tolerated Dose
Safety Indicator
Measured: Periprocedural
Any adverse events related to MSCs therapy
Safety Indicato
Measured: within 28 days after administration
Secondary outcomes (11)
Incidence of Clinically Significant Changes in Vital Signs from Baseline
Safety Indicato
Measured: within 28 days after administration
Incidence of clinically significant changes in laboratory tests from baseline
Safety Indicato
Measured: within 28 days after administration
male/female tumor marker positive rate
Safety Indicato
Measured: within 28 days after administration
all-cause mortality
Efficacy Endpoint
Measured: within 28 days after administration
Time of non-mechanical ventilation (days)
Efficacy Endpoint
Measured: within 28 days after administration
Non-intensive care time (days)
Efficacy Endpoint
Measured: within 28 days after administration
Time without organ failure (days)
Efficacy Endpoint
Measured: within 28 days after administration
PaO2/FiO2 varies from baseline
Efficacy Endpoint
Measured: 24 hours, 3, 7, 14, 28 days after infusion of test drug
Arterial blood gas analysis (pH, PaO _ 2, PaCO _ 2, Lac) changed from baseline
Efficacy Endpoint
Measured: 24 hours, 3, 7, 14, 28 days after infusion of test drug
Lung injury score changes from baseline
The minimum score is 0, and the maximum score is 4. A higher score indicates a more severe condition.
Efficacy Endpoint
Measured: Days 7, 14, 28
Sequential organ failure score changes from baseline
Minimum score 0, maximum score 24. The higher the score, the worse the prognosis Efficacy Endpoint
Measured: Days 3, 7, 14, 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2026
- Study start25 Apr 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Respiratory Distress SyndromeStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Changchun Tuohua Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Zhiyong Peng, Principal investigator, Zhongnan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07413978
- Sponsor's protocol ID
- TH-MSC-ARDS-101
- Acronym
- ARDS
- Status last verified
- Feb 2026
- First submitted
- 2 Feb 2026
- Last updated
- 17 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I-II, Open-label, Single-arm, Dose-escalation Clinical Trial to Evaluate the Safety and Tolerability of Human Umbilical Cord Mesenchymal Stem Cell Injection in the Treatment of Moderate to Severe Acute Respiratory Distress Syndrome
- ClinicalTrials.gov ID
- NCT07413978
- Acronym / sponsor ID
- ARDS / TH-MSC-ARDS-101
- Conditions
- Acute Respiratory Distress Syndrome
- Keywords
- Acute respiratory distress syndrome, ARDS, Human Umbilical Cord Mesenchymal Stem Cells
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Changchun Tuohua Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 25 Apr 2025 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 17 Feb 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.
Primary Objective: To evaluate the safety and tolerability of human umbilical cord mesenchymal stem cell injection in the treatment of moderate/severe acute respiratory distress syndrome.Secondary Objectives: To explore the efficacy and appropriate dosage of human umbilical cord mesenchymal stem cell injection in the treatment of moderate/severe acute respiratory distress syndrome.Exploratory Objective: To explore the immunogenicity and pharmacokinetic/pharmacodynamic (PK/PD) characteristics of a single dose of human umbilical cord mesenchymal stem cell injection in patients with moderate/severe acute respiratory distress syndrome.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Human Umbilical Cord Mesenchymal Stem Cells Injection | Experimental | Biological: 1 vial containing a total of 5×10^7 cells, Biological: 2 vial containing a total of 1×10^8 cells, Biological: 3 vial containing a total of 1.5×10^8 cells, Biological: 4 vial containing a total of 2×10^8 cellssingle-dose |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female patients aged 18 to 80 years (inclusive).
- Diagnosis of moderate or severe Acute Respiratory Distress Syndrome (ARDS) according to A New Global Definition of Acute Respiratory Distress Syndrome, with an infectious etiology.
- No improvement after 24 hours of conventional clinical treatment (defined as a persistent PaO₂/FiO₂ ratio ≤200 mmHg or a decrease from >200 mmHg to ≤200 mmHg after 24 hours of conventional supportive therapy; for severe ARDS, this assessment period may be shortened to 8 hours).
- Ability to fully understand the nature of the study and voluntarily provide written informed consent.
- Willingness to comply with all study procedures and demonstrate good compliance during the study period.
Key exclusion criteria (18 listed)
- Patients with ARDS caused by COVID-19 infection.
- Patients currently suffering from hepatitis B, hepatitis C, active or latent tuberculosis, AIDS, syphilis, immunodeficiency disorders, or other immune system diseases.
- Presence of severe cardiovascular diseases at screening, including:Cardiac function classification of NYHA class III or higher.Uncontrolled myocarditis or valvular disease.Malignant arrhythmia requiring pharmacological treatment.
- Abnormal liver or renal function at screening meeting any of the following criteria:ALT or AST ≥ 5 × ULN, or total bilirubin ≥ 3 × ULN.Serum creatinine ≥ 3 × ULN, or patients currently undergoing renal replacement therapy (CRRT).
- Patients receiving extracorporeal membrane oxygenation (ECMO) therapy at the time of screening.
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 |
|---|---|---|
| 1 vial containing a total of 5×10^7 cellsvenous reinfusion | Biological | Human Umbilical Cord Mesenchymal Stem Cells Injection |
| 2 vial containing a total of 1×10^8 cellsvenous reinfusion | Biological | Human Umbilical Cord Mesenchymal Stem Cells Injection |
| 3 vial containing a total of 1.5×10^8 cellsvenous reinfusion | Biological | Human Umbilical Cord Mesenchymal Stem Cells Injection |
| 4 vial containing a total of 2×10^8 cellsvenous reinfusion | Biological | Human Umbilical Cord Mesenchymal Stem Cells Injection |
Primary outcome
DLT incidence rate
Time frame: within 28 days after administration
Safety Indicator
Maximum Tolerated Dose
Time frame: Periprocedural
Safety Indicator
Any adverse events related to MSCs therapy
Time frame: within 28 days after administration
Safety Indicato
11 secondary outcomes
Incidence of Clinically Significant Changes in Vital Signs from Baseline
Time frame: within 28 days after administration
Incidence of clinically significant changes in laboratory tests from baseline
Time frame: within 28 days after administration
male/female tumor marker positive rate
Time frame: within 28 days after administration
all-cause mortality
Time frame: within 28 days after administration
Time of non-mechanical ventilation (days)
Time frame: within 28 days after administration
Non-intensive care time (days)
Time frame: within 28 days after administration
Time without organ failure (days)
Time frame: within 28 days after administration
PaO2/FiO2 varies from baseline
Time frame: 24 hours, 3, 7, 14, 28 days after infusion of test drug
Arterial blood gas analysis (pH, PaO _ 2, PaCO _ 2, Lac) changed from baseline
Time frame: 24 hours, 3, 7, 14, 28 days after infusion of test drug
Lung injury score changes from baseline
Time frame: Days 7, 14, 28
Sequential organ failure score changes from baseline
Time frame: Days 3, 7, 14, 28
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2026.
- Individual participant dataSharing planned: No
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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.
Zhiyong Peng principal investigator
Zhongnan 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 1 vial containing a total of 5×10^7 cells, 2 vial containing a total of 1×10^8 cells and 3 vial containing a total of 1.5×10^8 cells in people with Acute Respiratory Distress Syndrome, run by Changchun Tuohua Pharmaceutical 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 6 inclusion and 18 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: looking for participants now, as of the sponsor's last update on 17 Feb 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 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shi Cheng (+8618504341228, thswcs@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DLT incidence rate (time frame: within 28 days after administration). The study lists 3 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 17 Feb 2026.