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

ZhiYong Peng

Status and phase: Unknown; Phase 2

Conditions: Pneumonia, Ventilator-Associated; Pneumonia, Viral

Treatments: Biological: UC-MSCs

Study type: Interventional

Funder types: Other

Identifiers

NCT04269525

2020002

Details and patient eligibility

About

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.

Full 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.

Enrollment: 16 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No 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.

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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16 participants in 1 patient group

pneumonia

Experimental group

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.

Treatment:

Biological: UC-MSCs