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

Primary Purpose

Pneumonia, Viral, Pneumonia, Ventilator-Associated

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
UC-MSCs
Sponsored by
ZhiYong Peng
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pneumonia, Viral focused on measuring 2019-nCOV infection, UC-MSCs Treatment

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Zhongnan Hospital of Wuhan UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

pneumonia

Arm Description

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.

Outcomes

Primary Outcome Measures

Oxygenation index
partial arterial oxygen pressure (PaO2) / oxygen concentration (FiO2)

Secondary Outcome Measures

28 day mortality
whether the patient survives
Hospital stay
days of the patients in hospital
2019-nCoV antibody test
whether or not the 2019-nCoV antibody is positive
2019-nCoV nucleic acid test
whether or not the 2019-nCoV nucleic acid test is positive
Improvement of lung imaging examinations
whether lung imaging examinations show the improvement of the pneumonia
White blood cell count
counts of white blood cell in a litre of blood
Lymphocyte count
counts of lymphocyte in a litre (L) of blood
Procalcitonin
procalcitonin in microgram(ug)/L
interleukin(IL)-2
IL-2 in picogram(pg)/millilitre(mL)
IL-4
IL-4 in pg/mL
IL-6
IL-6 in pg/mL
IL-10
IL-10 in pg/mL
tumor necrosis factor(TNF)-α
TNF-α in nanogram(ng)/L
γ-interferon(IFN)
γ-IFN in a thousand unit (KU)/L
C-reactive protein(CRP)
CRP in microgram（μg）/L
CD4+ T-Lymphocytopenia
counts of CD4+ T-Lymphocytopenia in litre
CD8+ T-Lymphocytopenia
counts of CD8+ T-Lymphocytopenia in a litre
natural killer cell(NK)
counts of NK in a litre

Full Information

First Posted
February 7, 2020
Last Updated
June 29, 2020
Sponsor
ZhiYong Peng
Collaborators
Tuohua Biological Technology Co. Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT04269525
Brief Title
Umbilical Cord(UC)-Derived Mesenchymal Stem Cells(MSCs) Treatment for the 2019-novel Coronavirus(nCOV) Pneumonia
Official Title
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
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Unknown status
Study Start Date
February 6, 2020 (Actual)
Primary Completion Date
December 1, 2020 (Anticipated)
Study Completion Date
December 30, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
ZhiYong Peng
Collaborators
Tuohua Biological Technology Co. Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pneumonia, Viral, Pneumonia, Ventilator-Associated
Keywords
2019-nCOV infection, UC-MSCs Treatment

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
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)
Allocation
N/A
Enrollment
16 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
pneumonia
Arm Type
Experimental
Arm Description
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 Type
Biological
Intervention Name(s)
UC-MSCs
Intervention Description
After enrollment, each subject will receive UC-MSCs infusion intravenously on day 1, day 3, day 5, and day 7.
Primary Outcome Measure Information:
Title
Oxygenation index
Description
partial arterial oxygen pressure (PaO2) / oxygen concentration (FiO2)
Time Frame
on the day 14 after enrollment
Secondary Outcome Measure Information:
Title
28 day mortality
Description
whether the patient survives
Time Frame
on the day 28 after enrollment
Title
Hospital stay
Description
days of the patients in hospital
Time Frame
up to 6 months
Title
2019-nCoV antibody test
Description
whether or not the 2019-nCoV antibody is positive
Time Frame
on the day 7,14,28 after enrollment
Title
2019-nCoV nucleic acid test
Description
whether or not the 2019-nCoV nucleic acid test is positive
Time Frame
on the day 7,14,28 after enrollment
Title
Improvement of lung imaging examinations
Description
whether lung imaging examinations show the improvement of the pneumonia
Time Frame
on the day 7,14,28 after enrollment
Title
White blood cell count
Description
counts of white blood cell in a litre of blood
Time Frame
on the day 7,14,28 after enrollment
Title
Lymphocyte count
Description
counts of lymphocyte in a litre (L) of blood
Time Frame
on the day 7,14,28 after enrollment
Title
Procalcitonin
Description
procalcitonin in microgram(ug)/L
Time Frame
on the day 7,14,28 after enrollment
Title
interleukin(IL)-2
Description
IL-2 in picogram(pg)/millilitre(mL)
Time Frame
on the day 7,14,28 after enrollment
Title
IL-4
Description
IL-4 in pg/mL
Time Frame
on the day 7,14,28 after enrollment
Title
IL-6
Description
IL-6 in pg/mL
Time Frame
on the day 7,14,28 after enrollment
Title
IL-10
Description
IL-10 in pg/mL
Time Frame
on the day 7,14,28 after enrollment
Title
tumor necrosis factor(TNF)-α
Description
TNF-α in nanogram(ng)/L
Time Frame
on the day 7,14,28 after enrollment
Title
γ-interferon(IFN)
Description
γ-IFN in a thousand unit (KU)/L
Time Frame
on the day 7,14,28 after enrollment
Title
C-reactive protein(CRP)
Description
CRP in microgram（μg）/L
Time Frame
on the day 7,14,28 after enrollment
Title
CD4+ T-Lymphocytopenia
Description
counts of CD4+ T-Lymphocytopenia in litre
Time Frame
on the day 7,14,28 after enrollment
Title
CD8+ T-Lymphocytopenia
Description
counts of CD8+ T-Lymphocytopenia in a litre
Time Frame
on the day 7,14,28 after enrollment
Title
natural killer cell(NK)
Description
counts of NK in a litre
Time Frame
on the day 7,14,28 after enrollment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
XingHuan Wang, professor
Phone
18971387168
Email
znyylcsy@126.com
First Name & Middle Initial & Last Name or Official Title & Degree
ZhiYong Peng, professor
Phone
18672396028
Email
pengzy5@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
XingHuan Wang, professor
Organizational Affiliation
Wuhan University
Official's Role
Study Chair
Facility Information:
Facility Name
Zhongnan Hospital of Wuhan University
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
XingHuan Wang, professor
First Name & Middle Initial & Last Name & Degree
ZhiYong Peng, professor
First Name & Middle Initial & Last Name & Degree
XingHuan Wang
First Name & Middle Initial & Last Name & Degree
ZhiYong Peng

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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