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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
Sponsor:
Collaborator:
Ivy Institute of Stem Cells Co. Ltd
Information provided by (Responsible Party):
Affiliated Hospital to Academy of Military Medical Sciences

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Acute Lung Injury Acute Respiratory Distress Syndrome Biological: UCMSC group Phase 1 Phase 2

Detailed Description:

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)
Primary Purpose: Treatment
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


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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. ]
  2. 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. ]
  3. 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 ]
  4. 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
Criteria

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

Information from the National Library of Medicine

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


Contacts
Contact: Changqing Bai, M.D. +86-010-66947356 baicq307@163.com

Locations
China
Department of Respiration,Affiliated Hospital to Academy of Military Medical Sciences Recruiting
Beijing, China, 100071
Contact: Changqing Bai, M.D.    +86-010-66947356    baicq307@163.com   
Sponsors and Collaborators
Affiliated Hospital to Academy of Military Medical Sciences
Ivy Institute of Stem Cells Co. Ltd
Investigators
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
ClinicalTrials.gov Identifier: NCT02444455     History of Changes
Other Study ID Numbers: 307-IVY-SC-003
First Posted: May 14, 2015    Key Record Dates
Last Update Posted: May 14, 2015
Last Verified: May 2015

Keywords provided by Affiliated Hospital to Academy of Military Medical Sciences:
cellular therapy
acute lung injury
acute respiratory distress snydrome
human umbilical cord mesenchymal stem cell
phase 1/2 clinical study
allogeneic stem cell transplantation
ALI
ARDS

Additional relevant MeSH terms:
Wounds and Injuries
Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Acute Lung Injury
Lung Injury
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Thoracic Injuries