Acute Respiratory Distress SyndromePhase 1/2NCT06505941
Clinical Study on the Safety and Preliminary Efficacy of hUC-MSCs Intravenous Infusion Therapy for ARDS
A Phase 1/2 study testing umbilical cord mesenchymal stem cell in people with Acute Respiratory Distress Syndrome, run by Southeast University, China.
Trial summary
The object of this study is to observe the safety of umbilical cord mesenchymal stem cell therapy for acute respiratory distress syndrome, consisting with two phases. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Respiratory Distress Syndrome
- What is being tested?
- umbilical cord mesenchymal stem cell
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 20 Jul 2024to 20 Feb 2027
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age greater than 18 years, regardless of gender;
- Meeting the ARDS Berlin diagnostic criteria;
- Definite diagnosis within 72 hours;
- P/F < 150mmHg;
- Understanding and signing informed consent.
Who cannot join
- Women of childbearing potential with a positive serum pregnancy test before medication, pregnant women, or lactating women;
- ARDS directly caused by physical or chemical factors;
- Moderate to severe liver damage (Child-Pugh score >12);
- Chronic heart failure, New York Heart Association functional class IV;
- Severe kidney disease undergoing renal replacement therapy;
- Severe lung disease, Grade III or IV pulmonary hypertension, receiving oxygen therapy or ventilator support for more than one month in the six months prior to screening, end-stage lung disease, or severe physical limitations due to chest wall deformity;
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- Immunodeficiency, receiving immunosuppressive therapy within 2 weeks (except for low-dose corticosteroids), or with lymphoma, leukemia, or acquired immune deficiency syndrome; history of organ transplantation, bone marrow transplantation, or autologous hematopoietic stem cell suppression;
- Expected survival time of less than 48 hours due to terminal illness;
- Patients diagnosed with deep vein thrombosis (DVT) or pulmonary embolism (PE) in the past three months;
- Patients receiving ECMO therapy;
- Hepatitis B, hepatitis C, syphilis, or HIV infection.
- eGFR < 30ml/min/BSA;
- ALT > 5 × ULN;
- Absolute neutrophil count < 1500/μL;
- Subjects who have participated in other clinical studies within the past month (excluding those who have not received intervention), or are currently participating in other experimental treatments;
- Subjects deemed unlikely to benefit from the study by the investigator, or deemed unsuitable for participation in this study.
About this study
Official title: Clinical Study on the Safety and Preliminary Efficacy of Umbilical Cord Mesenchymal Stem Cell Intravenous Infusion Therapy for Acute Respiratory Distress Syndrome
The object of this study is to observe the safety of umbilical cord mesenchymal stem cell therapy for acute respiratory distress syndrome, consisting with two phases.
Read the detailed description
The secondary objectives are to observe the preliminary efficacy of umbilical cord mesenchymal stem cell therapy for acute respiratory distress syndrome. Phase One is an open-label, dose-escalation clinical study. Following safety and tolerability conclusions from Phase One, and upon evaluation and approval by the data safety committee and ethics committee, conduct Phase Two study, which will be a randomized, double-blind, placebo-controlled study. Dosage selection will be based on the safest and most effective dosage determined from Phase One results.
- Conditions
- Acute Respiratory Distress Syndrome
- Being tested
- umbilical cord mesenchymal stem cell, Placebo
- Keywords
- acute respiratry distress syndrome, human umbilical cord derived mesenchymal stem cell, clinical study
- 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.
umbilical cord mesenchymal stem cellDrug
Also called cell
umbilical cord mesenchymal stem cell
PlaceboDrug
non-cell-containing placebo
| Study group | Role | What they receive |
|---|---|---|
| placebo | Placebo comparator | 1 intravenous infusion of an equal volume of cell-free placebo. Receives: Drug: Placebo |
| MSC | Experimental | Name：Human umbilical cord mesenchymal stem cells Specification: 30 ml/bag Dosage: 1×106cells/kg, 5×106cells/kg, 10×106cells/kg Usage: Intravenous infusion The stem cells used in this study are human umbilical cord mesenchymal stem cells (hUC-MSCs), which are derived from umbilical cords donated by healthy mothers who have given birth in maternity hospitals. hUC-MSCs are extracted, processed, cultured and harvested from umbilical cord donors recruited by laboratories complying with the GMP standards. hUC-MSCs cell suspensions that have passed the quality control will be put into bags and transported to the hospitals for use by the subjects of the present clinical study. Receives: Drug: umbilical cord mesenchymal stem cell |
What is being measured
The primary outcome is the main question the study is designed to answer.
The safety of umbilical cord mesenchymal stem cell therapy for acute respiratory distress syndrome.
The 28-day mortality of patients receiving umbilical cord mesenchymal stem cell therapy
Measured: The 1, 6, 24 hours; 3、7、14、21 days and 4, 12, 24, 36, 48 weeks after injection.
Secondary outcomes (1)
The efficacy of umbilical cord mesenchymal stem cell therapy for acute respiratory distress syndrome.
Oxygenation index situation change (PaO2/FiO2) of patients receiving umbilical cord mesenchymal stem cell therapy
Measured: The 1, 6, 24 hours; 3、7、14、21 days and 4, 12, 24, 36, 48 weeks after injection.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2024
- Study start20 Jul 2024 (estimated)
- Primary completion20 Nov 2025 (estimated)
- Study completion20 Feb 2027 (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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Southeast University, China
- Sponsor type
- University, hospital or other
- Collaborators
- Zhongda Hospital, Yinguan Biologics, Shenzheng
- Responsible party
- Principal investigator, Jianfeng Xie, Southeast University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06505941
- Sponsor's protocol ID
- 2019ZDSYLL077-P06
- Status last verified
- Jul 2024
- First submitted
- 2 Apr 2024
- Last updated
- 17 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study on the Safety and Preliminary Efficacy of Umbilical Cord Mesenchymal Stem Cell Intravenous Infusion Therapy for Acute Respiratory Distress Syndrome
- ClinicalTrials.gov ID
- NCT06505941
- Acronym / sponsor ID
- 2019ZDSYLL077-P06
- Conditions
- Acute Respiratory Distress Syndrome
- Keywords
- acute respiratry distress syndrome, human umbilical cord derived mesenchymal stem cell, clinical study
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Southeast University, ChinaUniversity, hospital or other
- Collaborators
- Zhongda Hospital, Yinguan Biologics, Shenzheng
- Study start
- 20 Jul 2024 (estimated)
- Primary completion
- 20 Nov 2025 (estimated)
- Study completion
- 20 Feb 2027 (estimated)
- First posted
- 17 Jul 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 object of this study is to observe the safety of umbilical cord mesenchymal stem cell therapy for acute respiratory distress syndrome, consisting with two phases.
Detailed description
The secondary objectives are to observe the preliminary efficacy of umbilical cord mesenchymal stem cell therapy for acute respiratory distress syndrome. Phase One is an open-label, dose-escalation clinical study. Following safety and tolerability conclusions from Phase One, and upon evaluation and approval by the data safety committee and ethics committee, conduct Phase Two study, which will be a randomized, double-blind, placebo-controlled study. Dosage selection will be based on the safest and most effective dosage determined from Phase One results.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| placebo | Placebo comparator | Drug: Placebo1 intravenous infusion of an equal volume of cell-free placebo. |
| MSC | Experimental | Drug: umbilical cord mesenchymal stem cellName：Human umbilical cord mesenchymal stem cells Specification: 30 ml/bag Dosage: 1×106cells/kg, 5×106cells/kg, 10×106cells/kg Usage: Intravenous infusion The stem cells used in this study are human umbilical cord mesenchymal stem cells (hUC-MSCs), which are derived from umbilical cords donated by healthy mothers who have given birth in maternity hospitals. hUC-MSCs are extracted, processed, cultured and harvested from umbilical cord donors recruited by laboratories complying with the GMP standards. hUC-MSCs cell suspensions that have passed the quality control will be put into bags and transported to the hospitals for use by the subjects of the present clinical study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age greater than 18 years, regardless of gender;
- Meeting the ARDS Berlin diagnostic criteria;
- Definite diagnosis within 72 hours;
- P/F < 150mmHg;
- Understanding and signing informed consent.
Key exclusion criteria (16 listed)
- Women of childbearing potential with a positive serum pregnancy test before medication, pregnant women, or lactating women;
- ARDS directly caused by physical or chemical factors;
- Moderate to severe liver damage (Child-Pugh score >12);
- Chronic heart failure, New York Heart Association functional class IV;
- Severe kidney disease undergoing renal replacement therapy;
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 |
|---|---|---|
| umbilical cord mesenchymal stem cellAlso: cellumbilical cord mesenchymal stem cell | Drug | MSC |
| Placebonon-cell-containing placebo | Drug | placebo |
Primary outcome
The safety of umbilical cord mesenchymal stem cell therapy for acute respiratory distress syndrome.
Time frame: The 1, 6, 24 hours; 3、7、14、21 days and 4, 12, 24, 36, 48 weeks after injection.
The 28-day mortality of patients receiving umbilical cord mesenchymal stem cell therapy
1 secondary outcome
The efficacy of umbilical cord mesenchymal stem cell therapy for acute respiratory distress syndrome.
Time frame: The 1, 6, 24 hours; 3、7、14、21 days and 4, 12, 24, 36, 48 weeks after injection.
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 Jul 2024.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing umbilical cord mesenchymal stem cell in people with Acute Respiratory Distress Syndrome, run by Southeast University, 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 5 inclusion and 16 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: opening soon, as of the sponsor's last update on 17 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
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?
The safety of umbilical cord mesenchymal stem cell therapy for acute respiratory distress syndrome. (time frame: The 1, 6, 24 hours; 3、7、14、21 days and 4, 12, 24, 36, 48 weeks after injection.). 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 Jul 2024.