2019 Novel Coronavirus PneumoniaNCT04273646
Study of Human Umbilical Cord Mesenchymal Stem Cells in the Treatment of Severe COVID-19
A study testing UC-MSCs in people with 2019 Novel Coronavirus Pneumonia and COVID-19, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- 2019 Novel Coronavirus Pneumonia, COVID-19
- What is being tested?
- UC-MSCs
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteChina
- Study dates
- 20 Apr 2020to 15 Feb 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- CT image is characteristic of viral pneumonia;
- 2019-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);
- 18 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430000
About this study
Official title: Clinical Study of Human Umbilical Cord Mesenchymal Stem Cells in the Treatment of Severe COVID-19
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.
Read the detailed description
Since December 2019, Wuhan has successively found multiple cases of patients with pneumonia infected by a novel coronavirus. With the spread of the epidemic, other cases in China and abroad have also found such cases. As of 24:00 on February 1, 2020, a total of 14,380 confirmed cases were reported in China, of which there were 2110 severe cases and 304 death cases. At present, there is no effective treatment for pneumonia in the clinic against new coronavirus infection, especially severe and critical cases. Therefore, it is of great significance to explore more active and effective therapeutic approach to severe pneumonia patients infected with 2019-nCoV.
Human and animal studies have shown that after infection with coronavirus, the rapid replication of the virus in the body and the subsequent inflammatory response cause damage to alveolar epithelial cells and capillary endothelial cells, causing diffuse interstitial and alveolar edema, and pulmonary function. Impaired, leading to acute hypoxic respiratory insufficiency. The National Health and Medical Commission recently released the "New Coronavirus Infected Pneumonia Diagnosis and Treatment Plan (Trial Version 5)", which pointed out that the new type of coronavirus severe pneumonia usually has difficulty breathing after one week, and the severe cases quickly progress to acute respiratory distress syndrome, Septic shock and metabolic acidosis that is difficult to correct. It can be seen that the key to the treatment of new coronavirus severe pneumonia is to inhibit the super-inflammatory immune response caused by the virus, thereby reducing the damage of alveolar epithelial cells and capillary endothelial cells, and then repairing the structure and function of lung tissue.
Mesenchymal stem cells (MSCs) are one of the most studied and important adult stem cells. A large amount of evidence shows that MSCs can migrate to and return to damaged tissues, exert strong anti-inflammatory and immune regulatory functions, promote the regeneration and repair of damaged tissues, resist apoptosis and inhibit tissue fibrosis, and reduce tissue damage. Many studies have shown that the anti-inflammatory effects of MSCs can significantly reduce virus-induced lung injury and mortality in mice. Studies have shown that MSCs can significantly reduce acute lung injury in mice caused by H9N2 and H5N1 viruses by reducing the levels of proinflammatory cytokines and chemokines and reducing the recruitment of inflammatory cells into the lungs. Compared with MSCs from other sources, human umbilical cord-derived MSCs (umbilical cord MSCs, UC-MSCs) have been widely used because of their convenient collection, no ethical controversy, low immunogenicity, fast self-renewal and strong proliferation ability Research on the treatment of various diseases. Early research in this laboratory used UC-MSCs to intervene in endotoxin (LPS) -induced acute lung injury in mice, and confirmed that UC-MSCs can significantly reduce inflammatory cell infiltration in lung tissue, reduce inflammation in lung tissue, and significantly improve lung The structure and function of tissues protect mouse lung tissue from endotoxin-induced damage.
The purpose of this study is to investigate efficiency and safety of UC-MSCs in treating severe pneumonia patients infected with 2019-nCoV. This trial will recruit 48 patients. 24 patients received i.v. transfusion one round (4 times) of 5.0*10E6 cells/kg of UC-MSCs as the treated group, all of them received the conventional treatment. In addition, the equal 24 patients received conventional treatment were used as control group. The respiratory function, pulmonary inflammation, clinical symptoms, pulmonary imaging, side effects, 28-days mortality, immunological characteristics (immune cells, inflammatory factors, etc.) will be evaluated during the 90 days to 96 weeks follow up.
- Conditions
- 2019 Novel Coronavirus Pneumonia, COVID-19
- Being tested
- UC-MSCs, Placebo
- Keywords
- 2019 Novel Coronavirus Pneumonia, Safety, Efficiency, Cell Therapy, UC-MSCs
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UC-MSCsBiological
4 times of UC-MSCs(0.5*10E6 UC-MSCs/kg body weight intravenously at Day 1, Day 3, Day 5, Day 7).
PlaceboDrug
4 times of cell-free stem cell suspension (saline containing 1% human albumin) intravenously at Day 1, Day 3, Day 5, Day 7).
| Study group | Role | What they receive |
|---|---|---|
| UC-MSCs Treatment Group | Experimental | Conventional 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). Receives: Biological: UC-MSCs |
| Conventional Control Group | Placebo comparator | Conventional 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). Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pneumonia severity index
Evaluation of Pneumonia Improvement
Measured: From Baseline (0W) to 12 week after treatment
Oxygenation index (PaO2/FiO2)
Evaluation of Pneumonia Improvement
Measured: From Baseline (0W) to 12 week after treatment
Secondary outcomes (8)
Side effects in the UC-MSCs treatment group
Incidence of acute and chronic treatment-related adverse events in patients with novel coronavirus severe pneumonia receiving UC-MSCs infusion as assessed.
Measured: From Baseline (0W) to 96 week after treatment
28-days survival
Marker for efficacy of treatment
Measured: Day 28
Sequential organ failure assessment
Markers of organ function（Score each criterion on a scale of 0 to 4, and the higher the score, the worse the prognosis.）
Measured: Day 28
C-reactive protein
Markers of Infection
Measured: From Baseline (0W) to 12 week after treatment
Procalcitonin
Markers of Infection
Measured: From Baseline (0W) to 12 week after treatment
Lymphocyte count
Marker of Immunological function
Measured: From Baseline (0W) to 12 week after treatment
CD3+, CD4+ and CD8+ T celll count
Marker of Immunological function
Measured: From Baseline (0W) to 12 week after treatment
CD4+/CD8+ratio
Marker of Immunological function
Measured: From Baseline (0W) to 12 week after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2020
- Study start20 Apr 2020 (estimated)
- Primary completion30 Jun 2020 (estimated)
- Study completion15 Feb 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 2019 Novel Coronavirus PneumoniaStudies of the same condition, open and under way.
- More trials run by Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel Assignment
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Wuhan Hamilton Biotechnology Co., Ltd.
- Responsible party
- Principal investigator, Yang Jin, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04273646
- Sponsor's protocol ID
- 202001
- Status last verified
- Apr 2020
- First submitted
- 14 Feb 2020
- Last updated
- 14 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of Human Umbilical Cord Mesenchymal Stem Cells in the Treatment of Severe COVID-19
- ClinicalTrials.gov ID
- NCT04273646
- Acronym / sponsor ID
- 202001
- Conditions
- 2019 Novel Coronavirus Pneumonia, COVID-19
- Keywords
- 2019 Novel Coronavirus Pneumonia, Safety, Efficiency, Cell Therapy, UC-MSCs
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyUniversity, hospital or other
- Collaborators
- Wuhan Hamilton Biotechnology Co., Ltd.
- Study start
- 20 Apr 2020 (estimated)
- Primary completion
- 30 Jun 2020 (estimated)
- Study completion
- 15 Feb 2022 (estimated)
- First posted
- 18 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Since December 2019, Wuhan has successively found multiple cases of patients with pneumonia infected by a novel coronavirus. With the spread of the epidemic, other cases in China and abroad have also found such cases. As of 24:00 on February 1, 2020, a total of 14,380 confirmed cases were reported in China, of which there were 2110 severe cases and 304 death cases. At present, there is no effective treatment for pneumonia in the clinic against new coronavirus infection, especially severe and critical cases. Therefore, it is of great significance to explore more active and effective therapeutic approach to severe pneumonia patients infected with 2019-nCoV.
Human and animal studies have shown that after infection with coronavirus, the rapid replication of the virus in the body and the subsequent inflammatory response cause damage to alveolar epithelial cells and capillary endothelial cells, causing diffuse interstitial and alveolar edema, and pulmonary function. Impaired, leading to acute hypoxic respiratory insufficiency. The National Health and Medical Commission recently released the "New Coronavirus Infected Pneumonia Diagnosis and Treatment Plan (Trial Version 5)", which pointed out that the new type of coronavirus severe pneumonia usually has difficulty breathing after one week, and the severe cases quickly progress to acute respiratory distress syndrome, Septic shock and metabolic acidosis that is difficult to correct. It can be seen that the key to the treatment of new coronavirus severe pneumonia is to inhibit the super-inflammatory immune response caused by the virus, thereby reducing the damage of alveolar epithelial cells and capillary endothelial cells, and then repairing the structure and function of lung tissue.
Mesenchymal stem cells (MSCs) are one of the most studied and important adult stem cells. A large amount of evidence shows that MSCs can migrate to and return to damaged tissues, exert strong anti-inflammatory and immune regulatory functions, promote the regeneration and repair of damaged tissues, resist apoptosis and inhibit tissue fibrosis, and reduce tissue damage. Many studies have shown that the anti-inflammatory effects of MSCs can significantly reduce virus-induced lung injury and mortality in mice. Studies have shown that MSCs can significantly reduce acute lung injury in mice caused by H9N2 and H5N1 viruses by reducing the levels of proinflammatory cytokines and chemokines and reducing the recruitment of inflammatory cells into the lungs. Compared with MSCs from other sources, human umbilical cord-derived MSCs (umbilical cord MSCs, UC-MSCs) have been widely used because of their convenient collection, no ethical controversy, low immunogenicity, fast self-renewal and strong proliferation ability Research on the treatment of various diseases. Early research in this laboratory used UC-MSCs to intervene in endotoxin (LPS) -induced acute lung injury in mice, and confirmed that UC-MSCs can significantly reduce inflammatory cell infiltration in lung tissue, reduce inflammation in lung tissue, and significantly improve lung The structure and function of tissues protect mouse lung tissue from endotoxin-induced damage.
The purpose of this study is to investigate efficiency and safety of UC-MSCs in treating severe pneumonia patients infected with 2019-nCoV. This trial will recruit 48 patients. 24 patients received i.v. transfusion one round (4 times) of 5.0*10E6 cells/kg of UC-MSCs as the treated group, all of them received the conventional treatment. In addition, the equal 24 patients received conventional treatment were used as control group. The respiratory function, pulmonary inflammation, clinical symptoms, pulmonary imaging, side effects, 28-days mortality, immunological characteristics (immune cells, inflammatory factors, etc.) will be evaluated during the 90 days to 96 weeks follow up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Parallel Assignment
| Arm | Type | Receives |
|---|---|---|
| UC-MSCs Treatment Group | Experimental | Biological: UC-MSCsConventional 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 comparator | Drug: PlaceboConventional 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). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- CT image is characteristic of viral pneumonia;
- 2019-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);
- 18 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.
Key exclusion criteria (11 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UC-MSCs4 times of UC-MSCs(0.5*10E6 UC-MSCs/kg body weight intravenously at Day 1, Day 3, Day 5, Day 7). | Biological | UC-MSCs Treatment Group |
| Placebo4 times of cell-free stem cell suspension (saline containing 1% human albumin) intravenously at Day 1, Day 3, Day 5, Day 7). | Drug | Conventional Control Group |
Primary outcome
Pneumonia severity index
Time frame: From Baseline (0W) to 12 week after treatment
Evaluation of Pneumonia Improvement
Oxygenation index (PaO2/FiO2)
Time frame: From Baseline (0W) to 12 week after treatment
Evaluation of Pneumonia Improvement
8 secondary outcomes
Side effects in the UC-MSCs treatment group
Time frame: From Baseline (0W) to 96 week after treatment
28-days survival
Time frame: Day 28
Sequential organ failure assessment
Time frame: Day 28
C-reactive protein
Time frame: From Baseline (0W) to 12 week after treatment
Procalcitonin
Time frame: From Baseline (0W) to 12 week after treatment
Lymphocyte count
Time frame: From Baseline (0W) to 12 week after treatment
CD3+, CD4+ and CD8+ T celll count
Time frame: From Baseline (0W) to 12 week after treatment
CD4+/CD8+ratio
Time frame: From Baseline (0W) to 12 week after treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing UC-MSCs in people with 2019 Novel Coronavirus Pneumonia and COVID-19, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yang Jin, MD (+8613554361146, whuhjy@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pneumonia severity index (time frame: From Baseline (0W) to 12 week after treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2020.