Acute Lung InjuryEarly Phase 1NCT04951882
Application of hUC-MSCs in Treating Acute Lung Injury: a Single Center Prospective Clinical Research
A Early Phase 1 study testing human derived umbilical cord derived mesenchymal stem cells in people with Acute Lung Injury, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
The patients suffered from acute lung ininjury (200<PaO2/FiO2 ≤ 300) will be divided into two groups: MSCs-treated group: patients are treated by intravenous injection of hUC-MSCs suspention ; control group: patients were treated with vehicle(Albumin) . Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Acute Lung Injury
- What is being tested?
- human derived umbilical cord derived mesenchymal stem cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 9 Jun 2021to 31 Dec 2022
- Phase
- Early 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1.≤ 3 days (72h)
- 2.Age ≥18 years, ≤65 years
- 3.200<PaO2/FiO2 ≤ 300
- 4.Chest X-ray/chest CT : infiltrates of both lungs
- 5.Need assisted ventilation (ventilation or high flow oxygen therapy)
- 6.No left heart failure, pulmonary edema
- 7.Agree to participate and signe an informed consent
Who cannot join
- 1.Life expectancy <3 months due to non-respiratory failure
- 2.Patients receiving extracorporeal membrane oxygenation support therapy(ECMO),high frequency oscillatory ventilation
- 3.History of HIV, malignant tumors, or impaired immune function
- 4.Patients accepted major surgery in the past 14 days (such as tumor removal, thoracotomy, heart surgery, abdominal surgery, intracranial surgery, or surgery for more than 3 hours, etc.)
- 5.Pregnancy
- 6.Have a serious concomitant disease
Show all 10Show fewer
- 7.Unable to follow-up
- 8.History of severe allergic reactions or allergy to saline and serum
- 9.Already participated in another clinical study within 12 weeks
- 10.Pulmonary edema caused by other underlying diseases
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
SAHZU
Hanzhou, Zhejiang, 310009
Yongan Xu, 13757164833, xuyongan2000@163.com
About this study
Official title: Transplatation of Human Umbilcal Cord Derived Mesenchyamal Stem Cells in Acute Lung Injury: a Single Center Prospective Clinical Research
The patients suffered from acute lung ininjury (200<PaO2/FiO2 ≤ 300) will be divided into two groups: MSCs-treated group: patients are treated by intravenous injection of hUC-MSCs suspention ; control group: patients were treated with vehicle(Albumin) . The standard Therapies of acute lung injury were the same in both groups. In the following-up days, all the patients were monitored by the same items to evaluate the therapeutic effects.
- Conditions
- Acute Lung Injury
- Being tested
- human derived umbilical cord derived mesenchymal stem cells
- Medical subject headings
- Acute Lung Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
human derived umbilical cord derived mesenchymal stem cellsBiological
intravenous transplantation of human derived umbilical cord derived mesenchymal stem cells
| Study group | Role | What they receive |
|---|---|---|
| hUC-MSCs treatment | Placebo comparator | Patients of acute lung injury will be treated by suspention of hUC-MSCs and albumin combined with standard therapies. Receives: Biological: human derived umbilical cord derived mesenchymal stem cells |
| non-cell therapy | No intervention | Patients of acute lung injury will be treated by vehicle (albumin) combined with standard therapies. |
What is being measured
The primary outcome is the main question the study is designed to answer.
PaO2/FiO2
Oxygenation index
Measured: Day 3
PaO2/FiO2
Oxygenation index
Measured: Day 7
PaO2/FiO2
Oxygenation index
Measured: Day 14
PaO2/FiO2
Oxygenation index
Measured: Day 28
Secondary outcomes (4)
the days of ventialtion and hospital stay
the length of ventilation and hospital stay
Measured: Day 3
the days of ventialtion and hospital stay
the length of ventilation and hospital stay
Measured: Day 7
the days of ventialtion and hospital stay
the length of ventilation and hospital stay
Measured: Day 14
the days of ventialtion and hospital stay
the length of ventilation and hospital stay
Measured: Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2021
- Study start9 Jun 2021
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Lung InjuryStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04951882
- Sponsor's protocol ID
- 2020-592
- Status last verified
- Jun 2021
- First submitted
- 8 Jun 2021
- Last updated
- 7 Jul 2021
- 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 7 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transplatation of Human Umbilcal Cord Derived Mesenchyamal Stem Cells in Acute Lung Injury: a Single Center Prospective Clinical Research
- ClinicalTrials.gov ID
- NCT04951882
- Acronym / sponsor ID
- 2020-592
- Conditions
- Acute Lung Injury
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 9 Jun 2021 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 7 Jul 2021 (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 patients suffered from acute lung ininjury (200<PaO2/FiO2 ≤ 300) will be divided into two groups: MSCs-treated group: patients are treated by intravenous injection of hUC-MSCs suspention ; control group: patients were treated with vehicle(Albumin) . The standard Therapies of acute lung injury were the same in both groups. In the following-up days, all the patients were monitored by the same items to evaluate the therapeutic effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| hUC-MSCs treatment | Placebo comparator | Biological: human derived umbilical cord derived mesenchymal stem cellsPatients of acute lung injury will be treated by suspention of hUC-MSCs and albumin combined with standard therapies. |
| non-cell therapy | No intervention | –Patients of acute lung injury will be treated by vehicle (albumin) combined with standard therapies. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 1.≤ 3 days (72h)
- 2.Age ≥18 years, ≤65 years
- 3.200<PaO2/FiO2 ≤ 300
- 4.Chest X-ray/chest CT : infiltrates of both lungs
- 5.Need assisted ventilation (ventilation or high flow oxygen therapy)
Key exclusion criteria (10 listed)
- 1.Life expectancy <3 months due to non-respiratory failure
- 2.Patients receiving extracorporeal membrane oxygenation support therapy(ECMO),high frequency oscillatory ventilation
- 3.History of HIV, malignant tumors, or impaired immune function
- 4.Patients accepted major surgery in the past 14 days (such as tumor removal, thoracotomy, heart surgery, abdominal surgery, intracranial surgery, or surgery for more than 3 hours, etc.)
- 5.Pregnancy
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 |
|---|---|---|
| human derived umbilical cord derived mesenchymal stem cellsintravenous transplantation of human derived umbilical cord derived mesenchymal stem cells | Biological | hUC-MSCs treatment |
Primary outcome
PaO2/FiO2
Time frame: Day 3
Oxygenation index
PaO2/FiO2
Time frame: Day 7
Oxygenation index
PaO2/FiO2
Time frame: Day 14
Oxygenation index
PaO2/FiO2
Time frame: Day 28
Oxygenation index
4 secondary outcomes
the days of ventialtion and hospital stay
Time frame: Day 3
the days of ventialtion and hospital stay
Time frame: Day 7
the days of ventialtion and hospital stay
Time frame: Day 14
the days of ventialtion and hospital stay
Time frame: Day 28
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2021.
- 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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing human derived umbilical cord derived mesenchymal stem cells in people with Acute Lung Injury, run by Second Affiliated Hospital, Zhejiang University, School of Medicine 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 7 inclusion and 10 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 7 Jul 2021. 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 phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PaO2/FiO2 (time frame: Day 3). The study lists 4 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 7 Jul 2021.