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Application of hUC-MSCs in Treating Acute Lung Injury: a Single Center Prospective Clinical Research

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ClinicalTrials.gov Identifier: NCT04951882
Recruitment Status : Recruiting
First Posted : July 7, 2021
Last Update Posted : July 7, 2021
Sponsor:
Information provided by (Responsible Party):
Second Affiliated Hospital, School of Medicine, Zhejiang University

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.

Condition or disease Intervention/treatment Phase
Acute Lung Injury Biological: human derived umbilical cord derived mesenchymal stem cells Early Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Transplatation of Human Umbilcal Cord Derived Mesenchyamal Stem Cells in Acute Lung Injury: a Single Center Prospective Clinical Research
Actual Study Start Date : June 9, 2021
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: hUC-MSCs treatment
Patients of acute lung injury will be treated by suspention of hUC-MSCs and albumin combined with standard therapies.
Biological: human derived umbilical cord derived mesenchymal stem cells
intravenous transplantation of human derived umbilical cord derived mesenchymal stem cells

No Intervention: non-cell therapy
Patients of acute lung injury will be treated by vehicle (albumin) combined with standard therapies.



Primary Outcome Measures :
  1. PaO2/FiO2 [ Time Frame: Day 3 ]
    Oxygenation index

  2. PaO2/FiO2 [ Time Frame: Day 7 ]
    Oxygenation index

  3. PaO2/FiO2 [ Time Frame: Day 14 ]
    Oxygenation index

  4. PaO2/FiO2 [ Time Frame: Day 28 ]
    Oxygenation index


Secondary Outcome Measures :
  1. the days of ventialtion and hospital stay [ Time Frame: Day 3 ]
    the length of ventilation and hospital stay

  2. the days of ventialtion and hospital stay [ Time Frame: Day 7 ]
    the length of ventilation and hospital stay

  3. the days of ventialtion and hospital stay [ Time Frame: Day 14 ]
    the length of ventilation and hospital stay

  4. the days of ventialtion and hospital stay [ Time Frame: Day 28 ]
    the length of ventilation and hospital stay


Other Outcome Measures:
  1. IL-6 [ Time Frame: Day 1 ]
    inflammatory factors

  2. IL-6 [ Time Frame: Day 7 ]
    inflammatory factors

  3. IL-6 [ Time Frame: Day 14 ]
    inflammatory factors

  4. IL-6 [ Time Frame: Day 28 ]
    inflammatory factors

  5. IL-8 [ Time Frame: Day 1 ]
    inflammatory factors

  6. IL-8 [ Time Frame: Day 7 ]
    inflammatory factors

  7. IL-8 [ Time Frame: Day 14 ]
    inflammatory factors

  8. IL-8 [ Time Frame: Day 28 ]
    inflammatory factors

  9. TNF-a [ Time Frame: Day 3 ]
    inflammatory factors

  10. TNF-a [ Time Frame: Day 7 ]
    inflammatory factors

  11. TNF-a [ Time Frame: Day 14 ]
    inflammatory factors

  12. TNF-a [ Time Frame: Day 28 ]
    inflammatory factors



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04951882


Locations
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China, Zhejiang
SAHZU Recruiting
Hanzhou, Zhejiang, China, 310009
Contact: Yongan Xu    13757164833    xuyongan2000@163.com   
Sponsors and Collaborators
Second Affiliated Hospital, School of Medicine, Zhejiang University
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Responsible Party: Second Affiliated Hospital, School of Medicine, Zhejiang University
ClinicalTrials.gov Identifier: NCT04951882    
Other Study ID Numbers: 2020-592
First Posted: July 7, 2021    Key Record Dates
Last Update Posted: July 7, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lung Injury
Acute Lung Injury
Wounds and Injuries
Lung Diseases
Respiratory Tract Diseases
Thoracic Injuries