Acute Respiratory Distress SyndromeARDSNCT03608592
Human Umbilical Cord Mesenchymal Stem Cells (MSCs) Therapy in ARDS
A study testing umbilical cord derived mesenchymal stem cells (UCMSCs) suspension and normal saline in people with Acute Respiratory Distress Syndrome, run by Sun Yat-sen University at 1 site in China.
Trial summary
Acute respiratory distress syndrome (ARDS) is a devastating inflammatory and destructive disease in critical ill patients. Preclinical studies have shown a promising perspective of mesenchymal stem cells (MSCs) therapies in ARDS. 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 derived mesenchymal stem cells (UCMSCs) suspension and normal saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2018to 1 Dec 2020
- Phase
- Interventional
- 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
- Aged≥18 years old;
- Including all the criteria:
- Invasive ventilation, OI（PaO2/FiO2）<200; (2) PEEP≥8cmH2O; (3) Bilateral infiltration of lung in X-ray or CT; (4) In 1 week after onset; (5) Still OI<200 after protective ventilation or conservative fluid management.
Who cannot join
- Any malignant disease;
- Cardiogenic pulmonary edema;
- Over 50% atelectasis either lung lobe in X-ray;
- Pregnancy or perinatal or lactation;
- Previous end stage respiratory disease;
- More than 3 organs failure;
Show all 12Show fewer
- Liver failure with MELD(Model For End-Stage Liver Disease) score>40;
- Stage III or IV pulmonary hypertension;
- None invasive arterial and central venous catheter;
- Concurrent deep venous thrombus or pulmonary embolism in 3 months;
- Cerebral hernia;
- More than 96 hours after ARDS onset.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Huimin Yi
Guangzhou, Guangdong, 510630
Haijin Lv, 2082179173
About this study
Official title: Human Umbilical Cord Derived Mesenchymal Stem Cells Therapy in Acute Respiratory Distress Syndrome
Acute respiratory distress syndrome (ARDS) is a devastating inflammatory and destructive disease in critical ill patients. Preclinical studies have shown a promising perspective of mesenchymal stem cells (MSCs) therapies in ARDS. But the safety and efficacy of umbilical cord MSCs (UCMSCs) have not yet been convinced in clinical trails. This study will explore the safety and life-rescue potential of UCMSCs in refracotry ARDS.
Read the detailed description
This is a single arm study. According Berlin definition (2012), moderate or severe adult ARDS patients who fail to improve oxygenation (PaO2/FiO2 increase over 20%) in the first 24h or 8h after diagnosis will be enrolled. A salvage package of 10^6/kg suspended UCMSCs in 100ml normal saline or only 100ml normal saline will be infused through central venous catheter. Infusion associated events (IAEs) in 24 hours will be closely monitored. Compared with propensity score matched controls, mortality in 28 days as the primary outcomes. oxygenation index, ventilator parameters, lung injury biomarkers and clinical outcomes as secondary outcomes will be analyzed.
This is a revised trail from its previous registered pilot RCT, approved by Ethic Committe of Stem Cells Trails (ECSCT) of 3rd affiliated hospital of Sun Yat-Sen university
- Conditions
- Acute Respiratory Distress Syndrome
- Being tested
- umbilical cord derived mesenchymal stem cells (UCMSCs) suspension, normal saline
- Keywords
- refractory acuter respiratory distress syndrome, mesenchymal stem cells, salvage therapy
- 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 derived mesenchymal stem cells (UCMSCs) suspensionBiological
Clinical grade human umbilical cord derived mesenchymal stem cells (passage 3-5) suspension are provided by biotherapy center of the third affiliated hospital of Sun Yat Sen University. Cells are made of suspension packages (60million cells in 100ml normal saline per bag) and infused intravenously in 2 hours.
normal salineBiological
A bag of 100ml clinical grade normal saline are also provided by biotherapy center of the third affiliated hospital of Sun Yat Sen University.
| Study group | Role | What they receive |
|---|---|---|
| UCMSCs group | Experimental | Intravenous infusion of 1million UCMSCs per kilogram body weight suspended in 100ml normal saline, infusion duration 30-60min. Receives: Biological: umbilical cord derived mesenchymal stem cells (UCMSCs) suspension; Biological: normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Infusion associated events
Incidence of prescribed adverse events or unprescribed events agreed by investigators and consultant .
Measured: From infusion beginning to the second day, 24 hours
Mortality
All cause mortality. Cause of death, exact survival status (death/survival) and time (days) will also be recorded
Measured: In 60 days after enrolled
Secondary outcomes (7)
Ventilation free days(VFDs)
The days without invasive ventilator support(at least 2 consecutive calendar days) in 28 days.
If the ventilator weaned multiple times, VFDs is the sum of the days without ventilator support.
If any of following occurring in 28 days, VFDs equals 0:
- The patient dies in 28 days;
- Ventilator never be weaned;
- Censored case with ventilator never being weaned.
Measured: From the day of UCMSCs use(day 0) to day 28
Oxygenation index(OI) changes
The oxygenation index(OI)=partial pressure of oxygen in arterial blood(PaO2) divide inspiration fraction of oxygen(FiO2). OI is measured at day0, day1,day3,day7.
Measured: From day 0 to day 7, each day
Lung injury score(LIS)
Murray lung injury scores (LIS) consist of the following 4 parts:
A.Hypoxemia (PaO2/FiO2≥300, 225-299,175-224,100-174,<100, assigned 0,1,2,3,4 scores respectively); B.PEEP (cmH2O) (≤5,6-8,9-11,11-14,≥15, assigned 0,1,2,3,4 scores respectively) ; C.Compliance (ml/cmH2O)(≥80,60-79,40-59,20-39,≤19, assigned 0,1,2,3,4 scores respectively); D.Quadrants infiltrated in Chest X-Ray(CXR) (0,1,2,3,4, assigned 0,1,2,3,4 scores respectively).
The total LIS score is obtained by dividing the total sum of points by the number of criteria present. For example, if only 3 criteria are answered to, the total sum is divided by 3 to reveal the final score.
The LIS score ranges between 0 and 4, with scores closer to 4 indicating severe acute lung injury.
Measured: From day 0 to day 7, day0,1,3,7
Positive end expiratory pressure(PEEP)
Monitored by ventilator and recorded per hour, obtain the average value of the day. unit-cmH20
Measured: From day 0 to day 7, each day
Plateau pressure(Pplat)
Monitored by ventilator in one inspiration pause, measured 4 times a day. Record the average value of the day. unit-cmH20
Measured: From day 0 to day 7, each day
Driving pressure
Calculate the driving pressure by Pplat minus PEEP, measured 4 times a day. Record the average value of the day. unit-cmH20
Measured: From day 0 to day 7, each day
Static compliance
Calculate the static compliance by the following formula:
static compliance=tidal volume/(Pplat-PEEP), unit-ml/cmH2O
Measured: From day 0 to day 7, each day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2018
- Study start1 Jun 2018
- Primary completion1 Aug 2020 (estimated)
- Study completion1 Dec 2020 (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.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- A package of 100ml normal saline with 10\^6/kg umbilical cord derived MSCs suspension will infused from central venous catheter.
- Masking
- None (open label)
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lv Haijin, Sun Yat-sen University
- Investigators
- Huimin Yi, Principal investigator, The 3rd affiliated hospital of Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03608592
- Sponsor's protocol ID
- QHJH201804
- Acronym
- ARDS
- Status last verified
- Aug 2019
- First submitted
- 10 Jul 2018
- Last updated
- 4 Sep 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Human Umbilical Cord Derived Mesenchymal Stem Cells Therapy in Acute Respiratory Distress Syndrome
- ClinicalTrials.gov ID
- NCT03608592
- Acronym / sponsor ID
- ARDS / QHJH201804
- Conditions
- Acute Respiratory Distress Syndrome
- Keywords
- refractory acuter respiratory distress syndrome, mesenchymal stem cells, salvage therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 1 Aug 2020 (estimated)
- Study completion
- 1 Dec 2020 (estimated)
- First posted
- 1 Aug 2018 (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.
Acute respiratory distress syndrome (ARDS) is a devastating inflammatory and destructive disease in critical ill patients. Preclinical studies have shown a promising perspective of mesenchymal stem cells (MSCs) therapies in ARDS. But the safety and efficacy of umbilical cord MSCs (UCMSCs) have not yet been convinced in clinical trails. This study will explore the safety and life-rescue potential of UCMSCs in refracotry ARDS.
Detailed description
This is a single arm study. According Berlin definition (2012), moderate or severe adult ARDS patients who fail to improve oxygenation (PaO2/FiO2 increase over 20%) in the first 24h or 8h after diagnosis will be enrolled. A salvage package of 10^6/kg suspended UCMSCs in 100ml normal saline or only 100ml normal saline will be infused through central venous catheter. Infusion associated events (IAEs) in 24 hours will be closely monitored. Compared with propensity score matched controls, mortality in 28 days as the primary outcomes. oxygenation index, ventilator parameters, lung injury biomarkers and clinical outcomes as secondary outcomes will be analyzed.
This is a revised trail from its previous registered pilot RCT, approved by Ethic Committe of Stem Cells Trails (ECSCT) of 3rd affiliated hospital of Sun Yat-Sen university
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A package of 100ml normal saline with 10^6/kg umbilical cord derived MSCs suspension will infused from central venous catheter.
| Arm | Type | Receives |
|---|---|---|
| UCMSCs group | Experimental | Biological: umbilical cord derived mesenchymal stem cells (UCMSCs) suspension, Biological: normal salineIntravenous infusion of 1million UCMSCs per kilogram body weight suspended in 100ml normal saline, infusion duration 30-60min. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Aged≥18 years old;
- Including all the criteria:
- Invasive ventilation, OI（PaO2/FiO2）<200; (2) PEEP≥8cmH2O; (3) Bilateral infiltration of lung in X-ray or CT; (4) In 1 week after onset; (5) Still OI<200 after protective ventilation or conservative fluid management.
Key exclusion criteria (12 listed)
- Any malignant disease;
- Cardiogenic pulmonary edema;
- Over 50% atelectasis either lung lobe in X-ray;
- Pregnancy or perinatal or lactation;
- Previous end stage respiratory disease;
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 derived mesenchymal stem cells (UCMSCs) suspensionClinical grade human umbilical cord derived mesenchymal stem cells (passage 3-5) suspension are provided by biotherapy center of the third affiliated hospital of Sun Yat Sen University. Cells are made of suspension packages (60million cells in 100ml normal saline per bag) and infused intravenously in 2 hours. | Biological | UCMSCs group |
| normal salineA bag of 100ml clinical grade normal saline are also provided by biotherapy center of the third affiliated hospital of Sun Yat Sen University. | Biological | UCMSCs group |
Primary outcome
Infusion associated events
Time frame: From infusion beginning to the second day, 24 hours
Incidence of prescribed adverse events or unprescribed events agreed by investigators and consultant .
Mortality
Time frame: In 60 days after enrolled
All cause mortality. Cause of death, exact survival status (death/survival) and time (days) will also be recorded
7 secondary outcomes
Ventilation free days(VFDs)
Time frame: From the day of UCMSCs use(day 0) to day 28
Oxygenation index(OI) changes
Time frame: From day 0 to day 7, each day
Lung injury score(LIS)
Time frame: From day 0 to day 7, day0,1,3,7
Positive end expiratory pressure(PEEP)
Time frame: From day 0 to day 7, each day
Plateau pressure(Pplat)
Time frame: From day 0 to day 7, each day
Driving pressure
Time frame: From day 0 to day 7, each day
Static compliance
Time frame: From day 0 to day 7, each day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2019.
- Individual participant dataSharing planned: Undecided
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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.
Huimin Yi principal investigator
The 3rd affiliated hospital of Sun Yat-sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing umbilical cord derived mesenchymal stem cells (UCMSCs) suspension and normal saline in people with Acute Respiratory Distress Syndrome, run by Sun Yat-sen University 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 3 inclusion and 12 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 4 Sep 2019. 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.
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 Huimin Yi, Doctor (86-020-85252673, ylhmin@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Infusion associated events (time frame: From infusion beginning to the second day, 24 hours). 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 4 Sep 2019; AzTrials last refreshed its copy on 29 Oct 2026.