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

Overview

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.

Full Title of Study: “Clinical Research Regarding the Availability and Safety of UC-MSCs Treatment for Serious Pneumonia and Critical Pneumonia Caused by the 2019-nCOV Infection”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Prevention
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 1, 2020

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.

Interventions

  • Biological: UC-MSCs
    • After enrollment, each subject will receive UC-MSCs infusion intravenously on day 1, day 3, day 5, and day 7.

Arms, Groups and Cohorts

  • 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.

Clinical Trial Outcome Measures

Primary Measures

  • Oxygenation index
    • Time Frame: on the day 14 after enrollment
    • partial arterial oxygen pressure (PaO2) / oxygen concentration (FiO2)

Secondary Measures

  • 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

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • ZhiYong Peng
  • Collaborator
    • Tuohua Biological Technology Co. Ltd
  • Provider of Information About this Clinical Study
    • Sponsor-Investigator: ZhiYong Peng, professor – Zhongnan Hospital
  • Overall Official(s)
    • XingHuan Wang, professor, Study Chair, Wuhan University
  • Overall Contact(s)
    • XingHuan Wang, professor, 18971387168, znyylcsy@126.com

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