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

NCT04269525 | Unknown Phase 2

• 1 other identifier: 2020002
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Pneumonia, Viral; Pneumonia, Ventilator-Associated

Keywords

2019-nCOV infection; UC-MSCs Treatment

Outcome Measures

Primary Outcomes (1)

• Oxygenation index

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

  on the day 14 after enrollment

Secondary Outcomes (18)

• 28 day mortality

  on the day 28 after enrollment

• Hospital stay

  up to 6 months

• 2019-nCoV antibody test

  on the day 7,14,28 after enrollment

• 2019-nCoV nucleic acid test

  on the day 7,14,28 after enrollment

• Improvement of lung imaging examinations

  on the day 7,14,28 after enrollment

Study Arms (1)

pneumonia

EXPERIMENTAL

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

Interventions

UC-MSCs BIOLOGICAL

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

pneumonia

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• ZhiYong Peng: lead
• Tuohua Biological Technology Co. Ltd: collaborator

Study Sites (1)

Zhongnan Hospital of Wuhan University

Wuhan, Hubei, 430000, China

RECRUITING

MeSH Terms

Conditions

Pneumonia, Viral; Pneumonia, Ventilator-Associated; COVID-19

Condition Hierarchy (Ancestors)

Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Lung Diseases; Respiratory Tract Diseases; Healthcare-Associated Pneumonia; Cross Infection; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections

Study Officials

• XingHuan Wang, professor

  Wuhan University

  STUDY CHAIR

Central Study Contacts

XingHuan Wang, professor

CONTACT

18971387168; znyylcsy@126.com

ZhiYong Peng, professor

CONTACT

18672396028; pengzy5@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: professor

Model Details: reaching the criteria of pneumonia according to Diagnosis and Clinical Management of Pneumonia caused by 2019-nCoV Infection(Trial Version 4)

Study Record Dates

• First Submitted: February 7, 2020
• First Posted: February 13, 2020
• Study Start: February 6, 2020
• Primary Completion: December 1, 2020
• Study Completion: December 30, 2020
• Last Updated: July 1, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)