Trial | NCT04269525  Report issue

Title

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

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    16
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.
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 Started
Feb 06
2020
Primary Completion
Dec 01
2020
Anticipated
Study Completion
Dec 30
2020
Anticipated
Last Update
Jul 01
2020

Biological UC-MSCs

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

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.

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.
No Results Posted