Clinical trial NCT04269525: 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
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Pneumonia, Viral
Pneumonia, Ventilator-Associated
Keywords: 2019-nCOV infection
UC-MSCs Treatment
Lead sponsor: Zhongnan Hospital
Sponsor class: OTHER
Collaborators: name: Tuohua Biological Technology Co. Ltd
First posted: 2020-02-13
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: reaching the criteria of pneumonia according to Diagnosis and Clinical Management of Pneumonia caused by 2019-nCoV Infection(Trial Version 4)
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Oxygenation index
timeFrame: on the day 14 after enrollment
Secondary outcomes:
measure: 28 day mortality
timeFrame: on the day 28 after enrollment
measure: Hospital stay
timeFrame: up to 6 months
measure: 2019-nCoV antibody test
timeFrame: on the day 7,14,28 after enrollment
measure: 2019-nCoV nucleic acid test
timeFrame: on the day 7,14,28 after enrollment
measure: Improvement of lung imaging examinations
timeFrame: on the day 7,14,28 after enrollment
measure: White blood cell count
timeFrame: on the day 7,14,28 after enrollment
measure: Lymphocyte count
timeFrame: on the day 7,14,28 after enrollment
measure: Procalcitonin
timeFrame: on the day 7,14,28 after enrollment
measure: interleukin(IL)-2
timeFrame: on the day 7,14,28 after enrollment
measure: IL-4
timeFrame: on the day 7,14,28 after enrollment
measure: IL-6
timeFrame: on the day 7,14,28 after enrollment
measure: IL-10
timeFrame: on the day 7,14,28 after enrollment
measure: tumor necrosis factor(TNF)-α
timeFrame: on the day 7,14,28 after enrollment
measure: γ-interferon(IFN)
timeFrame: on the day 7,14,28 after enrollment
measure: C-reactive protein(CRP)
timeFrame: on the day 7,14,28 after enrollment
measure: CD4+ T-Lymphocytopenia
timeFrame: on the day 7,14,28 after enrollment
measure: CD8+ T-Lymphocytopenia
timeFrame: on the day 7,14,28 after enrollment
measure: natural killer cell(NK)
timeFrame: on the day 7,14,28 after enrollment
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Zhongnan Hospital of Wuhan University
state: Hubei
Study officials:
affiliation: Wuhan University
name: XingHuan Wang, professor
role: STUDY_CHAIR
References: