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

NCT04951882 | Unknown Early Phase 1 DMC

• 1 other identifier: 2020-592
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Lung Injury

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (4)

• the days of ventialtion and hospital stay

  Day 3

• the days of ventialtion and hospital stay

  Day 7

• the days of ventialtion and hospital stay

  Day 14

• the days of ventialtion and hospital stay

  Day 28

Other Outcomes (12)

• IL-6

  Day 1

• IL-6

  Day 7

• IL-6

  Day 14

Study Arms (2)

hUC-MSCs treatment

PLACEBO COMPARATOR

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

non-cell therapy

NO INTERVENTION

Patients of acute lung injury will be treated by vehicle (albumin) combined with standard therapies.

Interventions

human derived umbilical cord derived mesenchymal stem cells BIOLOGICAL

intravenous transplantation of human derived umbilical cord derived mesenchymal stem cells

hUC-MSCs treatment

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≤ 3 days (72h)
• Age ≥18 years, ≤65 years
• \<PaO2/FiO2 ≤ 300
• Chest X-ray/chest CT : infiltrates of both lungs
• Need assisted ventilation (ventilation or high flow oxygen therapy)
• No left heart failure, pulmonary edema
• Agree to participate and signe an informed consent

You may not qualify if:

• Life expectancy \<3 months due to non-respiratory failure
• Patients receiving extracorporeal membrane oxygenation support therapy(ECMO),high frequency oscillatory ventilation
• History of HIV, malignant tumors, or impaired immune function
• 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.)
• Pregnancy
• Have a serious concomitant disease
• Unable to follow-up
• History of severe allergic reactions or allergy to saline and serum
• Already participated in another clinical study within 12 weeks
• Pulmonary edema caused by other underlying diseases

Sponsors & Collaborators

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

Study Sites (1)

SAHZU

Hanzhou, Zhejiang, 310009, China

RECRUITING

MeSH Terms

Conditions

Acute Lung Injury

Condition Hierarchy (Ancestors)

Lung Injury; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2021
• First Posted: July 7, 2021
• Study Start: June 9, 2021
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: July 7, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)