Efficacy and Safety of Umbilical Cord Mesenchymal Stem Cells for the Treatment of Severe Viral Pneumonian
A Singlecenter, Randomized, Open Lable, Intervention Controlled Clinical Study on the Efficacy and Safety of Umbilical Cord Mesenchymal Stem Cells for the Treatment of Severe Viral Pneumonia
1 other identifier
interventional
40
1 country
1
Brief Summary
The purpose of this clinical study is to answer the questions:
- 1.Is the proposed intervention safe?
- 2.Is the proposed intervention effective in improving the health of subjects with severe viral pneumonia？
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Feb 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2020
CompletedFirst Submitted
Initial submission to the registry
February 13, 2020
CompletedFirst Posted
Study publicly available on registry
February 25, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2021
CompletedFebruary 25, 2020
February 1, 2020
11 months
February 13, 2020
February 21, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
mortality
The difference of 90 day mortality between the two groups will be observed and recorded
90 day
average length of stay
The difference of average length of stay between the two groups will be observed and recorded
90 day
Secondary Outcomes (6)
Changes of inflammatory index - the number of leukocyte or lymphocyte
Day 0, Day 1，Day 3，Day 7，Day 14，Day 30，Day 60，Day 90
Changes of inflammatory index - the percentage of lymphocytes
Day 0, Day 1，Day 3，Day 7，Day 14，Day 30，Day 60，Day 90
Changes of inflammatory index - cytokines
Day 0, Day 1，Day 3，Day 7，Day 14，Day 30，Day 60，Day 90
Changes of oxygenation index
Day 0, Day 1，Day 3，Day 7，Day 14，Day 30，Day 60，Day 90
Throat swab/blood viral load
Day 0, Day 1，Day 3，Day 7，Day 14，Day 30，Day 60，Day 90
- +1 more secondary outcomes
Study Arms (2)
Routine treatment group
ACTIVE COMPARATORParticipants will receive the treatment according to the treatment principle of severe and critical cases in "Influenza diagnosis and treatment plan (2019 version)"
HUC-MSCs adjuvant Group
EXPERIMENTALParticipants will receive intravenous infusion of definitive HUC-MSCs (1×10\^6 cells/Kg × body weight(kg), which was selected by immunomodulatory assay through coculture with BV2 cell) on the basis of the routine treatment.
Interventions
Definitive Human umbilical cord mesenchymal stem cells selected by immunomodulatory assay through coculture with BV2 cell
According to"Influenza diagnosis and treatment plan (2019 version)"
Eligibility Criteria
You may qualify if:
- The age is 18-75 years old (inclusive), and the gender is not limited;
- According to the diagnosis standard of viral pneumonia in the influenza diagnosis and treatment plan (2019 version), patients with severe viral pneumonia were diagnosed.
- Diagnostic criteria of viral pneumonia: with clinical manifestations of influenza, with one or more of the following pathogenic test results positive: 1) influenza virus nucleic acid test positive. 2) influenza antigen was positive. 3) the culture of influenza virus was positive. 4) the level of influenza virus specific IgG antibody in the acute and recovery serum was 4 times or more higher. Diagnosis criteria of severe viral pneumonia: the confirmed patients meet any of the following criteria: 1) continuous high fever for more than 3 days, accompanied by severe cough, expectoration, blood sputum, or chest pain; 2) rapid respiratory rate, dyspnea, cyanosis of mouth and lips; 3) mental changes: slow response, drowsiness, agitation, convulsion, etc.; 4) severe vomiting, diarrhea, dehydration; 5) pneumonia; 6 ）7. Other clinical conditions requiring hospitalization
- kg / m2 ≤ BMI ≤ 30 kg / m2;
- Volunteer to participate in the clinical study and sign the written informed consent.
You may not qualify if:
- Long term use of immunosuppressive drugs or organ transplantation;
- T lymphocyte abnormality (the use of allogeneic may be considered, according to the clinical opinion), HIV positive;
- High allergic constitution or severe allergic history, especially IL-2 allergic history;
- Pregnant and lactating women;
- Patients with a history of serious autoimmune diseases; those who are allergic to all biological agents in the treatment, such as IL-2;
- Patients with serious complications: Patients with chronic cardiac insufficiency (NYHA cardiac function grade IV), chronic renal insufficiency (CKD stage 4 or above), chronic liver insufficiency (child Pugh score \> 12), and patients with malignant tumors.
- There are other situations that the researcher thinks are not suitable for participating in this clinical study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Shanghai East Hospital
Shanghai, Shanghai Municipality, 200120, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Zhongmin Liu, MD/Ph.D
Shanghai East Hospital, Tongji University, Shanghai, China
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 13, 2020
First Posted
February 25, 2020
Study Start
February 1, 2020
Primary Completion
January 1, 2021
Study Completion
March 1, 2021
Last Updated
February 25, 2020
Record last verified: 2020-02