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

Overview

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.

Full Title of Study: “Transplatation of Human Umbilcal Cord Derived Mesenchyamal Stem Cells in Acute Lung Injury: a Single Center Prospective Clinical Research”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 31, 2022

Interventions

  • Biological: human derived umbilical cord derived mesenchymal stem cells
    • intravenous transplantation of human derived umbilical cord derived mesenchymal stem cells

Arms, Groups and Cohorts

  • Placebo Comparator: hUC-MSCs treatment
    • Patients of acute lung injury will be treated by suspention of hUC-MSCs and albumin combined with standard therapies.
  • No Intervention: non-cell therapy
    • Patients of acute lung injury will be treated by vehicle (albumin) combined with standard therapies.

Clinical Trial Outcome Measures

Primary Measures

  • 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

Secondary Measures

  • the days of ventialtion and hospital stay
    • Time Frame: Day 3
    • the length of ventilation and hospital stay
  • the days of ventialtion and hospital stay
    • Time Frame: Day 7
    • the length of ventilation and hospital stay
  • the days of ventialtion and hospital stay
    • Time Frame: Day 14
    • the length of ventilation and hospital stay
  • the days of ventialtion and hospital stay
    • Time Frame: Day 28
    • the length of ventilation and hospital stay

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Second Affiliated Hospital, School of Medicine, Zhejiang University
  • Provider of Information About this Clinical Study
    • Sponsor

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