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

• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04951882
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 18.7
• Patients Per Site Per Month: 1.6

Study Details

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.

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

Study Design

• Study Type: Interventional
• Anticipated 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: Jun 9, 2021
• Anticipated Primary Completion Date: Dec 31, 2022
• Anticipated Study Completion Date: Dec 31, 2022

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. PaO2/FiO2 [Day 3]

   Oxygenation index

2. PaO2/FiO2 [Day 7]

   Oxygenation index

3. PaO2/FiO2 [Day 14]

   Oxygenation index

4. PaO2/FiO2 [Day 28]

   Oxygenation index

Secondary Outcome Measures

1. the days of ventialtion and hospital stay [Day 3]

   the length of ventilation and hospital stay

2. the days of ventialtion and hospital stay [Day 7]

   the length of ventilation and hospital stay

3. the days of ventialtion and hospital stay [Day 14]

   the length of ventilation and hospital stay

4. the days of ventialtion and hospital stay [Day 28]

   the length of ventilation and hospital stay

Other Outcome Measures

1. IL-6 [Day 1]

   inflammatory factors

2. IL-6 [Day 7]

   inflammatory factors

3. IL-6 [Day 14]

   inflammatory factors

4. IL-6 [Day 28]

   inflammatory factors

5. IL-8 [Day 1]

   inflammatory factors

6. IL-8 [Day 7]

   inflammatory factors

7. IL-8 [Day 14]

   inflammatory factors

8. IL-8 [Day 28]

   inflammatory factors

9. TNF-a [Day 3]

   inflammatory factors

10. TNF-a [Day 7]

    inflammatory factors

11. TNF-a [Day 14]

    inflammatory factors

12. TNF-a [Day 28]

    inflammatory factors

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	SAHZU	Hanzhou	Zhejiang	China	310009

Sponsors and Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Second Affiliated Hospital, School of Medicine, Zhejiang University
• ClinicalTrials.gov Identifier: NCT04951882
• Other Study ID Numbers: 2020-592
• First Posted: Jul 7, 2021
• Last Update Posted: Jul 7, 2021
• Last Verified: Jun 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Lung Injury; Acute Lung Injury; Wounds and Injuries

Study Results

No Results Posted as of Jul 7, 2021