Back to resultsApplication of hUC-MSCs in Treating Acute Lung Injury: a Single Center Prospective Clinical Research
Primary Purpose
Acute Lung Injury
Status
Unknown status
Phase
Early Phase 1
Locations
China
Study Type
Interventional
Intervention
human derived umbilical cord derived mesenchymal stem cells
Sponsored by
About this trial
This is an interventional treatment trial for Acute Lung Injury
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
Sites / Locations
- SAHZURecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
No Intervention
Arm Label
hUC-MSCs treatment
non-cell therapy
Arm Description
Patients of acute lung injury will be treated by suspention of hUC-MSCs and albumin combined with standard therapies.
Patients of acute lung injury will be treated by vehicle (albumin) combined with standard therapies.
Outcomes
Primary Outcome Measures
PaO2/FiO2
Oxygenation index
PaO2/FiO2
Oxygenation index
PaO2/FiO2
Oxygenation index
PaO2/FiO2
Oxygenation index
Secondary Outcome Measures
the days of ventialtion and hospital stay
the length of ventilation and hospital stay
the days of ventialtion and hospital stay
the length of ventilation and hospital stay
the days of ventialtion and hospital stay
the length of ventilation and hospital stay
the days of ventialtion and hospital stay
the length of ventilation and hospital stay
Full Information
NCT ID
NCT04951882
First Posted
June 8, 2021
Last Updated
June 27, 2021
Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
1. Study Identification
Unique Protocol Identification Number
NCT04951882
Brief Title
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
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Unknown status
Study Start Date
June 9, 2021 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Lung Injury
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
hUC-MSCs treatment
Arm Type
Placebo Comparator
Arm Description
Patients of acute lung injury will be treated by suspention of hUC-MSCs and albumin combined with standard therapies.
Arm Title
non-cell therapy
Arm Type
No Intervention
Arm Description
Patients of acute lung injury will be treated by vehicle (albumin) combined with standard therapies.
Intervention Type
Biological
Intervention Name(s)
human derived umbilical cord derived mesenchymal stem cells
Intervention Description
intravenous transplantation of human derived umbilical cord derived mesenchymal stem cells
Primary Outcome Measure Information:
Title
PaO2/FiO2
Description
Oxygenation index
Time Frame
Day 3
Title
PaO2/FiO2
Description
Oxygenation index
Time Frame
Day 7
Title
PaO2/FiO2
Description
Oxygenation index
Time Frame
Day 14
Title
PaO2/FiO2
Description
Oxygenation index
Time Frame
Day 28
Secondary Outcome Measure Information:
Title
the days of ventialtion and hospital stay
Description
the length of ventilation and hospital stay
Time Frame
Day 3
Title
the days of ventialtion and hospital stay
Description
the length of ventilation and hospital stay
Time Frame
Day 7
Title
the days of ventialtion and hospital stay
Description
the length of ventilation and hospital stay
Time Frame
Day 14
Title
the days of ventialtion and hospital stay
Description
the length of ventilation and hospital stay
Time Frame
Day 28
Other Pre-specified Outcome Measures:
Title
IL-6
Description
inflammatory factors
Time Frame
Day 1
Title
IL-6
Description
inflammatory factors
Time Frame
Day 7
Title
IL-6
Description
inflammatory factors
Time Frame
Day 14
Title
IL-6
Description
inflammatory factors
Time Frame
Day 28
Title
IL-8
Description
inflammatory factors
Time Frame
Day 1
Title
IL-8
Description
inflammatory factors
Time Frame
Day 7
Title
IL-8
Description
inflammatory factors
Time Frame
Day 14
Title
IL-8
Description
inflammatory factors
Time Frame
Day 28
Title
TNF-a
Description
inflammatory factors
Time Frame
Day 3
Title
TNF-a
Description
inflammatory factors
Time Frame
Day 7
Title
TNF-a
Description
inflammatory factors
Time Frame
Day 14
Title
TNF-a
Description
inflammatory factors
Time Frame
Day 28
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
SAHZU
City
Hanzhou
State/Province
Zhejiang
ZIP/Postal Code
310009
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yongan Xu
Phone
13757164833
Email
xuyongan2000@163.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Application of hUC-MSCs in Treating Acute Lung Injury: a Single Center Prospective Clinical Research
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