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

Pneumonia, Viral Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04269525
• Other study ID #: 2020002
• Status: Recruiting
• Phase: Phase 2
• Start date: February 6, 2020
• Est. completion date: December 30, 2020

Study information

• Verified date: June 2020
• Source: Zhongnan Hospital
• Contact: XingHuan Wang, professor
• Phone: 18971387168
• Email: znyylcsy[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 16
• Est. completion date: December 30, 2020
• Est. primary completion date: December 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pneumonia
• Pneumonia, Ventilator-Associated
• Pneumonia, Viral

Intervention

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

Locations

Country	Name	City	State
China	Zhongnan Hospital of Wuhan University	Wuhan	Hubei

Sponsors (2)

Lead Sponsor	Collaborator
ZhiYong Peng	Tuohua Biological Technology Co. Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Oxygenation index	partial arterial oxygen pressure (PaO2) / oxygen concentration (FiO2)	on the day 14 after enrollment
Secondary	28 day mortality	whether the patient survives	on the day 28 after enrollment
Secondary	Hospital stay	days of the patients in hospital	up to 6 months
Secondary	2019-nCoV antibody test	whether or not the 2019-nCoV antibody is positive	on the day 7,14,28 after enrollment
Secondary	2019-nCoV nucleic acid test	whether or not the 2019-nCoV nucleic acid test is positive	on the day 7,14,28 after enrollment
Secondary	Improvement of lung imaging examinations	whether lung imaging examinations show the improvement of the pneumonia	on the day 7,14,28 after enrollment
Secondary	White blood cell count	counts of white blood cell in a litre of blood	on the day 7,14,28 after enrollment
Secondary	Lymphocyte count	counts of lymphocyte in a litre (L) of blood	on the day 7,14,28 after enrollment
Secondary	Procalcitonin	procalcitonin in microgram(ug)/L	on the day 7,14,28 after enrollment
Secondary	interleukin(IL)-2	IL-2 in picogram(pg)/millilitre(mL)	on the day 7,14,28 after enrollment
Secondary	IL-4	IL-4 in pg/mL	on the day 7,14,28 after enrollment
Secondary	IL-6	IL-6 in pg/mL	on the day 7,14,28 after enrollment
Secondary	IL-10	IL-10 in pg/mL	on the day 7,14,28 after enrollment
Secondary	tumor necrosis factor(TNF)-a	TNF-a in nanogram(ng)/L	on the day 7,14,28 after enrollment
Secondary	?-interferon(IFN)	?-IFN in a thousand unit (KU)/L	on the day 7,14,28 after enrollment
Secondary	C-reactive protein(CRP)	CRP in microgram(µg)/L	on the day 7,14,28 after enrollment
Secondary	CD4+ T-Lymphocytopenia	counts of CD4+ T-Lymphocytopenia in litre	on the day 7,14,28 after enrollment
Secondary	CD8+ T-Lymphocytopenia	counts of CD8+ T-Lymphocytopenia in a litre	on the day 7,14,28 after enrollment
Secondary	natural killer cell(NK)	counts of NK in a litre	on the day 7,14,28 after enrollment