Study of Human Umbilical Cord Mesenchymal Stem Cells in the Treatment of Severe COVID-19
Clinical Study of Human Umbilical Cord Mesenchymal Stem Cells in the Treatment of Severe COVID-19
1 other identifier
interventional
48
1 country
1
Brief Summary
The novel coronavirus pneumonia is a kind of new emerging respiratory infectious disease, characterized by fever, dry cough, and chest tightness, and caused by the infection of the 2019 novel coronavirus (2019-nCoV). In severe cases, there will be rapid respiratory system failure. The novel coronavirus pneumonia is extremely contagious and the disease progresses rapidly. It has become a urgent and serious public health event that threatens human life and health globally. Among them, severe pneumonia caused by novel coronavirus is characterized by extensive acute inflammation of the lungs and the patient is critically ill. At present, there is no effective treatment in clinical practice.Most of them should receive supportive care to help relieve symptoms. For severe cases, treatment should include care to support vital organ functions. This clinical trial is to inspect the safety and efficiency of Human Umbilical Cord Mesenchymal Stem Cells (UC-MSCs) therapy for severe pneumonia patients infected with 2019-nCoV.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Apr 2020
Typical duration for not_applicable
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
First Submitted
Initial submission to the registry
February 14, 2020
CompletedFirst Posted
Study publicly available on registry
February 18, 2020
CompletedStudy Start
First participant enrolled
April 20, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
February 15, 2022
CompletedApril 14, 2020
April 1, 2020
2 months
February 14, 2020
April 10, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Pneumonia severity index
Evaluation of Pneumonia Improvement
From Baseline (0W) to 12 week after treatment
Oxygenation index (PaO2/FiO2)
Evaluation of Pneumonia Improvement
From Baseline (0W) to 12 week after treatment
Secondary Outcomes (8)
Side effects in the UC-MSCs treatment group
From Baseline (0W) to 96 week after treatment
28-days survival
Day 28
Sequential organ failure assessment
Day 28
C-reactive protein
From Baseline (0W) to 12 week after treatment
Procalcitonin
From Baseline (0W) to 12 week after treatment
- +3 more secondary outcomes
Study Arms (2)
UC-MSCs Treatment Group
EXPERIMENTALConventional treatment plus UC-MSCs: Participants will receive conventional treatment plus 4 times of UC-MSCs(0.5\*10E6 UC-MSCs/kg body weight intravenously at Day 1，Day 3，Day 5，Day7).
Conventional Control Group
PLACEBO COMPARATORConventional treatment plus Placebo: Without UC-MSCs Therapy but conventional treatment should be received. Participants will receive conventional treatment plus 4 times of Placebo intravenously at Day 1，Day 3，Day 5，Day7).
Interventions
Eligibility Criteria
You may qualify if:
- CT image is characteristic of viral pneumonia;
- ncov infection (positive nucleic acid test) is confirmed by pathogenic test;
- In compliance with the 2019-nCoV infection severe pneumonia diagnosis standard (according to the novel coronavirus infection pneumonia diagnosis and treatment program (Trial Implementation Version 5) issued by the National Health and Medical Commission, and WHO 2019 new coronavirus guidelines standards). It is severe if it meets any of the following: (A) Increased breathing rate (≥30 beats / min), difficulty breathing, cyanosis of the lips; (B) When inhaling, means oxygen saturation ≤93%; (C) Partial pressure of arterial oxygen (PaO2) / Fraction of inspired oxygen (FiO2) ≤300 mmHg (1mmHg = 0.133kPa);
- years old ≤ age ≤ 65 years old, regardless of gender;
- The patient or legal donor agrees to participate in the study and signs the informed consent.
You may not qualify if:
- Patients with severe allergies or allergies to stem cell preparations and their components;
- Patients with serious basic diseases that affect survival, including: blood diseases, cachexia, active bleeding, severe malnutrition, etc .;
- Patients with pulmonary obstructive pneumonia, severe pulmonary interstitial fibrosis, alveolar proteinosis, allergic alveolitis, and other known viral pneumonia or bacterial pneumonia;
- Continuous use of immunosuppressive agents or organ transplants in the past 6 months;
- In vitro life support (ECMO, ECCO2R, RRT);
- Expected deaths within 48 hours, uncontrolled infections;
- Patients with malignant blood-borne diseases such as HIV or syphilis;
- Patient with pregnancy, are planning to become pregnant or breastfeeding;
- Patients with poor compliance and unable to complete the full study;
- The investigator determines that there may be increased risk of the subject or other conditions that interfere with the clinical trial and the judgment of the results (such as excessive stress, sensitivity or cognitive impairment, etc.);
- There are other situations that the researchers think are not suitable to participate in this clinical study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430000, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principle Investigator, Clinical Professor of Department of Respiratory and Critical Care Medicine,
Study Record Dates
First Submitted
February 14, 2020
First Posted
February 18, 2020
Study Start
April 20, 2020
Primary Completion
June 30, 2020
Study Completion
February 15, 2022
Last Updated
April 14, 2020
Record last verified: 2020-04
Data Sharing
- IPD Sharing
- Will not share