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

Clinical Research Regarding the Availability and Safety of UC-MSCs Treatment for Serious Pneumonia and Critical Pneumonia Caused by the 2019-nCOV Infection

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.

Study Overview

• Status: Unknown
• Conditions: Pneumonia, Viral; Pneumonia, Ventilator-Associated
• Intervention / Treatment: Biological: UC-MSCs

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: Interventional
• Enrollment (Anticipated): 16
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: XingHuan Wang, professor; Phone Number: 18971387168; Email: znyylcsy@126.com
• Study Contact Backup: Name: ZhiYong Peng, professor; Phone Number: 18672396028; Email: pengzy5@hotmail.com

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China, 430000
      • Recruiting
      • Zhongnan Hospital of Wuhan University
      • Contact: XingHuan Wang, professor
      • Contact: zhiyong peng, professor
      • Principal Investigator: XingHuan Wang
      • Principal Investigator: ZhiYong Peng

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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.

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
28 day mortality	whether the patient survives	on the day 28 after enrollment
Hospital stay	days of the patients in hospital	up to 6 months
2019-nCoV antibody test	whether or not the 2019-nCoV antibody is positive	on the day 7,14,28 after enrollment
2019-nCoV nucleic acid test	whether or not the 2019-nCoV nucleic acid test is positive	on the day 7,14,28 after enrollment
Improvement of lung imaging examinations	whether lung imaging examinations show the improvement of the pneumonia	on the day 7,14,28 after enrollment
White blood cell count	counts of white blood cell in a litre of blood	on the day 7,14,28 after enrollment
Lymphocyte count	counts of lymphocyte in a litre (L) of blood	on the day 7,14,28 after enrollment
Procalcitonin	procalcitonin in microgram(ug)/L	on the day 7,14,28 after enrollment
interleukin(IL)-2	IL-2 in picogram(pg)/millilitre(mL)	on the day 7,14,28 after enrollment
IL-4	IL-4 in pg/mL	on the day 7,14,28 after enrollment
IL-6	IL-6 in pg/mL	on the day 7,14,28 after enrollment
IL-10	IL-10 in pg/mL	on the day 7,14,28 after enrollment
tumor necrosis factor(TNF)-α	TNF-α in nanogram(ng)/L	on the day 7,14,28 after enrollment
γ-interferon(IFN)	γ-IFN in a thousand unit (KU)/L	on the day 7,14,28 after enrollment
C-reactive protein(CRP)	CRP in microgram（μg）/L	on the day 7,14,28 after enrollment
CD4+ T-Lymphocytopenia	counts of CD4+ T-Lymphocytopenia in litre	on the day 7,14,28 after enrollment
CD8+ T-Lymphocytopenia	counts of CD8+ T-Lymphocytopenia in a litre	on the day 7,14,28 after enrollment
natural killer cell(NK)	counts of NK in a litre	on the day 7,14,28 after enrollment

Collaborators and Investigators

• Sponsor: ZhiYong Peng
• Collaborators: Tuohua Biological Technology Co. Ltd
• Investigators: Study Chair: XingHuan Wang, professor, Wuhan University

Study record dates

Study Major Dates

• Study Start (Actual): February 6, 2020
• Primary Completion (Anticipated): December 1, 2020
• Study Completion (Anticipated): December 30, 2020

Study Registration Dates

• First Submitted: February 7, 2020
• First Submitted That Met QC Criteria: February 12, 2020
• First Posted (Actual): February 13, 2020

Study Record Updates

• Last Update Posted (Actual): July 1, 2020
• Last Update Submitted That Met QC Criteria: June 29, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: 2019-nCOV infection; UC-MSCs Treatment
• Additional Relevant MeSH Terms: Pathologic Processes; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Disease Attributes; Cross Infection; Iatrogenic Disease; Healthcare-Associated Pneumonia; Pneumonia; Pneumonia, Viral; Pneumonia, Ventilator-Associated
• Other Study ID Numbers: 2020002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No