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

NCT ID: NCT04951882

Last Updated: 2021-07-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

EARLY_PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-09

Study Completion Date

2022-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Acute Lung Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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hUC-MSCs treatment

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

Group Type PLACEBO_COMPARATOR

human derived umbilical cord derived mesenchymal stem cells

Intervention Type BIOLOGICAL

intravenous transplantation of human derived umbilical cord derived mesenchymal stem cells

non-cell therapy

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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human derived umbilical cord derived mesenchymal stem cells

intravenous transplantation of human derived umbilical cord derived mesenchymal stem cells

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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SAHZU

Hanzhou, Zhejiang, China

Site Status RECRUITING

Countries

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China

Facility Contacts

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Yongan Xu

Role: primary

13757164833

Other Identifiers

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2020-592

Identifier Type: -

Identifier Source: org_study_id

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