Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Human Umbilical-Cord-Derived Mesenchymal Stem Cell Therapy in Acute Lung Injury (UCMSC-ALI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE May 8, 2015
First Posted Date  ICMJE May 14, 2015
Last Update Posted Date May 14, 2015
Study Start Date  ICMJE May 2015
Estimated Primary Completion Date March 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 11, 2015)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: May 11, 2015)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Human Umbilical-Cord-Derived Mesenchymal Stem Cell Therapy in Acute Lung Injury
Official Title  ICMJE Safety and Efficacy of Human Umbilical-Cord-Derived Mesenchymal Stem Cell Transplantation in Acute Lung Injury
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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Acute Lung Injury
  • Acute Respiratory Distress Syndrome
Intervention  ICMJE Biological: UCMSC group
Human umbilical cord MSCs are transplanted by intravenous infusion(5×10^5/kg) once a day,a total of three times.
Study Arms  ICMJE Experimental: UCMSC group
Human umbilical cord MSCs are administrated to patients by intravenous infusion
Intervention: Biological: UCMSC group
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: May 11, 2015)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2017
Estimated Primary Completion Date March 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 35 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02444455
Other Study ID Numbers  ICMJE 307-IVY-SC-003
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Affiliated Hospital to Academy of Military Medical Sciences
Study Sponsor  ICMJE Affiliated Hospital to Academy of Military Medical Sciences
Collaborators  ICMJE Ivy Institute of Stem Cells Co. Ltd
Investigators  ICMJE
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
PRS Account Affiliated Hospital to Academy of Military Medical Sciences
Verification Date May 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP