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

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.

Study Overview

• Status: Recruiting
• Conditions: Acute Lung Injury
• Intervention / Treatment: Biological: human derived umbilical cord derived mesenchymal stem cells

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Hanzhou, Zhejiang, China, 310009
      • Recruiting
      • SAHZU
      • Contact: Yongan Xu; Phone Number: 13757164833; Email: xuyongan2000@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PaO2/FiO2	Oxygenation index	Day 3
PaO2/FiO2	Oxygenation index	Day 7
PaO2/FiO2	Oxygenation index	Day 14
PaO2/FiO2	Oxygenation index	Day 28

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the days of ventialtion and hospital stay	the length of ventilation and hospital stay	Day 3
the days of ventialtion and hospital stay	the length of ventilation and hospital stay	Day 7
the days of ventialtion and hospital stay	the length of ventilation and hospital stay	Day 14
the days of ventialtion and hospital stay	the length of ventilation and hospital stay	Day 28

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
IL-6	inflammatory factors	Day 1
IL-6	inflammatory factors	Day 7
IL-6	inflammatory factors	Day 14
IL-6	inflammatory factors	Day 28
IL-8	inflammatory factors	Day 1
IL-8	inflammatory factors	Day 7
IL-8	inflammatory factors	Day 14
IL-8	inflammatory factors	Day 28
TNF-a	inflammatory factors	Day 3
TNF-a	inflammatory factors	Day 7
TNF-a	inflammatory factors	Day 14
TNF-a	inflammatory factors	Day 28

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

Study record dates

Study Major Dates

• Study Start (Actual): June 9, 2021
• Primary Completion (Anticipated): December 31, 2022
• Study Completion (Anticipated): December 31, 2022

Study Registration Dates

• First Submitted: June 8, 2021
• First Submitted That Met QC Criteria: June 27, 2021
• First Posted (Actual): July 7, 2021

Study Record Updates

• Last Update Posted (Actual): July 7, 2021
• Last Update Submitted That Met QC Criteria: June 27, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Thoracic Injuries; Wounds and Injuries; Acute Lung Injury; Lung Injury
• Other Study ID Numbers: 2020-592

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No