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Umbilical Cord(UC)-Derived Mesenchymal Stem Cells(MSCs) Treatment for the 2019-novel Coronavirus(nCOV) Pneumonia

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04269525
Recruitment Status : Recruiting
First Posted : February 13, 2020
Last Update Posted : July 1, 2020
Sponsor:
Collaborator:
Tuohua Biological Technology Co. Ltd
Information provided by (Responsible Party):
ZhiYong Peng, Zhongnan Hospital

Tracking Information
First Submitted Date  ICMJE February 7, 2020
First Posted Date  ICMJE February 13, 2020
Last Update Posted Date July 1, 2020
Actual Study Start Date  ICMJE February 6, 2020
Estimated Primary Completion Date December 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 12, 2020)		 Oxygenation index [ Time Frame: on the day 14 after enrollment ]
partial arterial oxygen pressure (PaO2) / oxygen concentration (FiO2)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 29, 2020)
  • 28 day mortality [ Time Frame: on the day 28 after enrollment ]
    whether the patient survives
  • Hospital stay [ Time Frame: up to 6 months ]
    days of the patients in hospital
  • 2019-nCoV antibody test [ Time Frame: on the day 7,14,28 after enrollment ]
    whether or not the 2019-nCoV antibody is positive
  • 2019-nCoV nucleic acid test [ Time Frame: on the day 7,14,28 after enrollment ]
    whether or not the 2019-nCoV nucleic acid test is positive
  • Improvement of lung imaging examinations [ Time Frame: on the day 7,14,28 after enrollment ]
    whether lung imaging examinations show the improvement of the pneumonia
  • White blood cell count [ Time Frame: on the day 7,14,28 after enrollment ]
    counts of white blood cell in a litre of blood
  • Lymphocyte count [ Time Frame: on the day 7,14,28 after enrollment ]
    counts of lymphocyte in a litre (L) of blood
  • Procalcitonin [ Time Frame: on the day 7,14,28 after enrollment ]
    procalcitonin in microgram(ug)/L
  • interleukin(IL)-2 [ Time Frame: on the day 7,14,28 after enrollment ]
    IL-2 in picogram(pg)/millilitre(mL)
  • IL-4 [ Time Frame: on the day 7,14,28 after enrollment ]
    IL-4 in pg/mL
  • IL-6 [ Time Frame: on the day 7,14,28 after enrollment ]
    IL-6 in pg/mL
  • IL-10 [ Time Frame: on the day 7,14,28 after enrollment ]
    IL-10 in pg/mL
  • tumor necrosis factor(TNF)-α [ Time Frame: on the day 7,14,28 after enrollment ]
    TNF-α in nanogram(ng)/L
  • γ-interferon(IFN) [ Time Frame: on the day 7,14,28 after enrollment ]
    γ-IFN in a thousand unit (KU)/L
  • C-reactive protein(CRP) [ Time Frame: on the day 7,14,28 after enrollment ]
    CRP in microgram（μg）/L
  • CD4+ T-Lymphocytopenia [ Time Frame: on the day 7,14,28 after enrollment ]
    counts of CD4+ T-Lymphocytopenia in litre
  • CD8+ T-Lymphocytopenia [ Time Frame: on the day 7,14,28 after enrollment ]
    counts of CD8+ T-Lymphocytopenia in a litre
  • natural killer cell(NK) [ Time Frame: on the day 7,14,28 after enrollment ]
    counts of NK in a litre
Original Secondary Outcome Measures  ICMJE
 (submitted: February 12, 2020)
  • 28 day mortality [ Time Frame: on the day 28 after enrollment ]
    whether the patient survives
  • Hospital stay [ Time Frame: up to 6 months ]
    days of the patients in hospital
  • 2019-nCoV nucleic acid test [ Time Frame: on the day 7,14,28 after enrollment ]
    whether or not the 2019-nCoV nucleic acid test is positive
  • Improvement of lung imaging examinations [ Time Frame: on the day 7,14,28 after enrollment ]
    whether lung imaging examinations show the improvement of the pneumonia
  • White blood cell count [ Time Frame: on the day 7,14,28 after enrollment ]
    counts of white blood cell in a litre of blood
  • Lymphocyte count [ Time Frame: on the day 7,14,28 after enrollment ]
    counts of lymphocyte in a litre (L) of blood
  • Lymphocyte percentage [ Time Frame: on the day 7,14,28 after enrollment ]
    percentage of lymphocyte in white blood cell
  • Procalcitonin [ Time Frame: on the day 7,14,28 after enrollment ]
    procalcitonin in microgram(ug)/L
  • interleukin(IL)-2 [ Time Frame: on the day 7,14,28 after enrollment ]
    IL-2 in picogram(pg)/millilitre(mL)
  • IL-4 [ Time Frame: on the day 7,14,28 after enrollment ]
    IL-4 in pg/mL
  • IL-6 [ Time Frame: on the day 7,14,28 after enrollment ]
    IL-6 in pg/mL
  • IL-8 [ Time Frame: on the day 7,14,28 after enrollment ]
    IL-8 in pg/mL
  • IL-10 [ Time Frame: on the day 7,14,28 after enrollment ]
    IL-10 in pg/mL
  • tumor necrosis factor(TNF)-α [ Time Frame: on the day 7,14,28 after enrollment ]
    TNF-α in nanogram(ng)/L
  • γ-interferon(IFN) [ Time Frame: on the day 7,14,28 after enrollment ]
    γ-IFN in a thousand unit (KU)/L
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Umbilical Cord(UC)-Derived Mesenchymal Stem Cells(MSCs) Treatment for the 2019-novel Coronavirus(nCOV) Pneumonia
Official Title  ICMJE Clinical Research Regarding the Availability and Safety of UC-MSCs Treatment for Serious Pneumonia and Critical Pneumonia Caused by the 2019-nCOV Infection
Brief Summary Serious Pneumonia and Critical Pneumonia caused by the 2019-nCOV infection greatly threats patients' life, UC-MSCs treatment has been proved to play a role in curing multiple diseases. And this study is conducted to find out whether or not it will function in 2019-nCOV infection Pneumonia.
Detailed Description Serious Pneumonia and Critical Pneumonia caused by the 2019-nCOV infection greatly threats patients' life, UC-MSCs treatment has been proved to play a role in curing multiple diseases. And this study is conducted to find out whether or not it will function in 2019-nCOV infection Pneumonia. And we are going to get the permission of the enrolled patients. Besides the present clinical treatment, UC-MSCs treatment will be applied to those fulfilling the enrollment. After a period of UC-MSCs treatment, the analysis of UC-MSCs treatment will be completed from related aspects.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:
reaching the criteria of pneumonia according to Diagnosis and Clinical Management of Pneumonia caused by 2019-nCoV Infection(Trial Version 4)
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Pneumonia, Viral
  • Pneumonia, Ventilator-Associated
Intervention  ICMJE Biological: UC-MSCs
After enrollment, each subject will receive UC-MSCs infusion intravenously on day 1, day 3, day 5, and day 7.
Study Arms  ICMJE Experimental: pneumonia
According to Diagnosis and Clinical Management of Pneumonia caused by 2019-nCoV Infection(Trial Version 4), patients enrolled will be divided to serious pneumonia group or critical pneumonia group. All subjects will receive UC-MSCs 3.3 * 107 cell number / 50ml / bag, 3 bags each time. And UC-MSCs will be infused intravenously on the 1st, 3rd, 5th, and 7th days after enrollment, 1 time each day. The efficacy and safety of the treatment, patients' adverse reactions will be monitored.
Intervention: Biological: UC-MSCs
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 Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 22, 2020)		 16
Original Estimated Enrollment  ICMJE
 (submitted: February 12, 2020)		 10
Estimated Study Completion Date  ICMJE December 30, 2020
Estimated Primary Completion Date December 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 18-80 years old ,no gender restriction
  • According to Diagnosis and Clinical Management of Pneumonia caused by 2019-nCoV infection(Trial Version 6), patients are diagnosed with severe or critical 2019-nCoV pneumonia
  • Women of childbearing age should have a negative blood pregnancy test before the start of dosing and agree to take effective contraceptive measures during the trial until the last follow-up (28 days)
  • Previous detection of Nucleotide or antibody of 2019-nCoV pneumonia was positive
  • Voluntarily participate in this clinical study and sign a written informed consent. If the patient cannot obtain informed consent, he can authorize his legal representative.

Exclusion Criteria:

  • Liver SOFA score of more than 3 points;
  • HIV positive
  • Highly allergic constitution or history of severe allergies;
  • Pregnant and lactating women;
  • Patients with malignant tumors;
  • Patients with previous history of pulmonary embolism;
  • Participating in clinical trials of other drugs within 3 months before enrollment.
  • be thought by researchers to be inappropriate to participate in this clinical study.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: XingHuan Wang, professor 18971387168 znyylcsy@126.com
Contact: ZhiYong Peng, professor 18672396028 pengzy5@hotmail.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04269525
Other Study ID Numbers  ICMJE 2020002
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party ZhiYong Peng, Zhongnan Hospital
Original Responsible Party Same as current
Current Study Sponsor  ICMJE ZhiYong Peng
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Tuohua Biological Technology Co. Ltd
Investigators  ICMJE
Study Chair: XingHuan Wang, professor Wuhan University
PRS Account Zhongnan Hospital
Verification Date June 2020

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