Human Umbilical-Cord-Derived Mesenchymal Stem Cell Therapy in Acute Lung Injury
NCT ID: NCT02444455
Last Updated: 2015-05-14
Study Results
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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UNKNOWN
PHASE1/PHASE2
20 participants
INTERVENTIONAL
2015-05-31
2017-12-31
Brief Summary
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Detailed Description
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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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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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UCMSC group
Human umbilical cord MSCs are administrated to patients by intravenous infusion
UCMSC group
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
35 Years
70 Years
ALL
No
Sponsors
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Ivy Institute of Stem Cells Co. Ltd
INDUSTRY
Affiliated Hospital to Academy of Military Medical Sciences
OTHER
Responsible Party
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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
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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307-IVY-SC-003
Identifier Type: -
Identifier Source: org_study_id
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