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

Zhejiang University

Status and phase: Unknown; Early Phase 1

Conditions: Acute Lung Injury

Treatments: Biological: human derived umbilical cord derived mesenchymal stem cells

Study type: Interventional

Funder types: Other

Identifiers

NCT04951882

2020-592

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups, including a placebo group

hUC-MSCs treatment

Placebo Comparator group

Description:

Patients of acute lung injury will be treated by suspention of hUC-MSCs and albumin combined with standard therapies.

Treatment:

Biological: human derived umbilical cord derived mesenchymal stem cells

non-cell therapy

No Intervention group

Description:

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