Human Umbilical-Cord-Derived Mesenchymal Stem Cell Therapy in Acute Lung Injury (UCMSC-ALI)
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|ClinicalTrials.gov Identifier: NCT02444455|
Recruitment Status : Unknown
Verified May 2015 by Affiliated Hospital to Academy of Military Medical Sciences.
Recruitment status was: Recruiting
First Posted : May 14, 2015
Last Update Posted : May 14, 2015
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|Condition or disease||Intervention/treatment||Phase|
|Acute Lung Injury Acute Respiratory Distress Syndrome||Biological: UCMSC group||Phase 1 Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Safety and Efficacy of Human Umbilical-Cord-Derived Mesenchymal Stem Cell Transplantation in Acute Lung Injury|
|Study Start Date :||May 2015|
|Estimated Primary Completion Date :||March 2017|
|Estimated Study Completion Date :||December 2017|
Experimental: UCMSC group
Human umbilical cord MSCs are administrated to patients by intravenous infusion
Biological: UCMSC group
Human umbilical cord MSCs are transplanted by intravenous infusion(5×10^5/kg) once a day,a total of three times.
- Safety will be determined by the assessment of major adverse events [ Time Frame: From day 0 at the start of treatment to day 14. ]Safety will be determined by the assessment of major adverse events defined as death, and the incidence of prespecified infusion-associated events and non-serious adverse events thought to be related to the MSC infusion.
- Quantify pulmonary respiratory function measured by chest computerized tomography [ Time Frame: Participants will be followed for the duration of hospital,2 day post-infusion, and days 7,14. ]
- The efficacy of UC-MSC treatment was measured by arterial blood gas analysis [ Time Frame: Participants will be followed for the duration of hospital,2 day post-infusion, and days 7,14. ]
- The efficacy of UC-MSC treatment was measured by biological markers,including markers of inflammation，IL-6 [ Time Frame: 6 hours post-infusion, and days 1, 2, and 3 ]
- The efficacy of UC-MSC treatment was measured by biological markers,including markers of inflammation，IL-8 [ Time Frame: 6 hours post-infusion, and days 1, 2, and 3 ]
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|Ages Eligible for Study:||35 Years to 70 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02444455
|Contact: Changqing Bai, M.D.||+email@example.com|
|Department of Respiration,Affiliated Hospital to Academy of Military Medical Sciences||Recruiting|
|Beijing, China, 100071|
|Contact: Changqing Bai, M.D. +86-010-66947356 firstname.lastname@example.org|
|Study Chair:||Bing Liu, M.D.||307-IVY Translational Medicine Center|
|Study Director:||Changqing Bai, M.D.||Department of Respiration, Affiliated Hospital to Academy of Military Medical Sciences|
|Principal Investigator:||Huiying Liu, M.D.||Department of Respiration, Affiliated Hospital to Academy of Military Medical Sciences|
|Responsible Party:||Affiliated Hospital to Academy of Military Medical Sciences|
|Other Study ID Numbers:||
|First Posted:||May 14, 2015 Key Record Dates|
|Last Update Posted:||May 14, 2015|
|Last Verified:||May 2015|
acute lung injury
acute respiratory distress snydrome
human umbilical cord mesenchymal stem cell
phase 1/2 clinical study
allogeneic stem cell transplantation
Respiratory Distress Syndrome
Respiratory Distress Syndrome, Newborn
Acute Lung Injury
Wounds and Injuries
Respiratory Tract Diseases
Infant, Premature, Diseases
Infant, Newborn, Diseases