Clinical trial NCT04951882: Application of hUC-MSCs in Treating Acute Lung Injury: a Single Center Prospective Clinical Research
Official title: Transplatation of Human Umbilcal Cord Derived Mesenchyamal Stem Cells in Acute Lung Injury: a Single Center Prospective Clinical Research
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Acute Lung Injury
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2021-07-07
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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) . 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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
* 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

Primary outcomes:
measure: PaO2/FiO2
timeFrame: Day 3
measure: PaO2/FiO2
timeFrame: Day 7
measure: PaO2/FiO2
timeFrame: Day 14
measure: PaO2/FiO2
timeFrame: Day 28
Secondary outcomes:
measure: the days of ventialtion and hospital stay
timeFrame: Day 3
measure: the days of ventialtion and hospital stay
timeFrame: Day 7
measure: the days of ventialtion and hospital stay
timeFrame: Day 14
measure: the days of ventialtion and hospital stay
timeFrame: Day 28
Other outcomes:
measure: IL-6
timeFrame: Day 1
measure: IL-6
timeFrame: Day 7
measure: IL-6
timeFrame: Day 14
measure: IL-6
timeFrame: Day 28
measure: IL-8
timeFrame: Day 1
measure: IL-8
timeFrame: Day 7
measure: IL-8
timeFrame: Day 14
measure: IL-8
timeFrame: Day 28
measure: TNF-a
timeFrame: Day 3
measure: TNF-a
timeFrame: Day 7
measure: TNF-a
timeFrame: Day 14
measure: TNF-a
timeFrame: Day 28
Locations:
city: Hanzhou
country: China
facility: SAHZU
state: Zhejiang
Study officials:
References: