Human Umbilical-Cord-Derived Mesenchymal Stem Cell Therapy in Acute Lung Injury

NCT ID: NCT02444455

Last Updated: 2015-05-14

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

PHASE1/PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-05-31

Study Completion Date

2017-12-31

Brief Summary

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Phase I-II Clinical Trial - Safety and efficacy of umbilical-cord-derived mesenchymal stem cell (UC-MSC) in patients with Acute Lung Injury ,open label, controlled prospective study.

Detailed Description

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Phase I-II Clinical Trial - Safety and efficacy of umbilical-cord-derived mesenchymal stem cell (UC-MSC) in patients with acute lung injury,open label, controlled prospective study.

Every patient will maintain their standard treatment of acute lung injury, with maximum tolerated dosage without side effects.

The day of infusion will be considered day zero. From that moment, followup will be divided into 2,7,14 days.

Clinical results will be analyzed after completion of 14 days of followup.

Conditions

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Acute Lung Injury Acute Respiratory Distress Syndrome

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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UCMSC group

Human umbilical cord MSCs are administrated to patients by intravenous infusion

Group Type EXPERIMENTAL

UCMSC group

Intervention Type BIOLOGICAL

Human umbilical cord MSCs are transplanted by intravenous infusion(5×10\^5/kg) once a day,a total of three times.

Interventions

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UCMSC group

Human umbilical cord MSCs are transplanted by intravenous infusion(5×10\^5/kg) once a day,a total of three times.

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Signed informed consent
* Age between 35 and 70 y
* Acute onset within 7 days.
* Oxygenation index:200\<PaO2/FiO2≤300mmHg; alveolar-arterial oxygen differences:P(A-a)O2\>35mmHg
* Bilateral infiltrates on chest radiography
* No cardiac failure

Exclusion Criteria

* Declined to sign informed consent
* Socially and mentally disabilities
* Malignant diseases
* Combined with severe infectious diseases
* Patients with positive blood tests for Hepatitis B or Hepatitis C or HIV or tuberculosis at the time of screening
* Pregnant or perinatal women
* Severe diseases of any major organs
Minimum Eligible Age

35 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ivy Institute of Stem Cells Co. Ltd

INDUSTRY

Sponsor Role collaborator

Affiliated Hospital to Academy of Military Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bing Liu, M.D.

Role: STUDY_CHAIR

307-IVY Translational Medicine Center

Changqing Bai, M.D.

Role: STUDY_DIRECTOR

Department of Respiration, Affiliated Hospital to Academy of Military Medical Sciences

Huiying Liu, M.D.

Role: PRINCIPAL_INVESTIGATOR

Department of Respiration, Affiliated Hospital to Academy of Military Medical Sciences

Locations

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Department of Respiration,Affiliated Hospital to Academy of Military Medical Sciences

Beijing, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Changqing Bai, M.D.

Role: CONTACT

+86-010-66947356

Facility Contacts

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Changqing Bai, M.D.

Role: primary

+86-010-66947356

Other Identifiers

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307-IVY-SC-003

Identifier Type: -

Identifier Source: org_study_id

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