Coronavirus Disease 2019 (COVID-19)Phase 1/2NCT04346368
Bone Marrow-Derived Mesenchymal Stem Cell Treatment for Severe Patients With Coronavirus Disease 2019 (COVID-19)
A Phase 1/2 study testing BM-MSCs in people with Coronavirus Disease 2019 (COVID-19), run by Guangzhou Institute of Respiratory Disease at 1 site in China.
Trial summary
Coronavirus Disease 2019 (COVID-19) is spreading worldwide and has become a public health emergency of major international concern. Currently, no specific drugs or vaccines are available. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Coronavirus Disease 2019 (COVID-19)
- What is being tested?
- BM-MSCs
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- Apr 2020to Dec 2020
- Phase
- Phase 1/2
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Willing and able to provide written informed consent prior to performing study procedures
- Age ≥18 years, and ≤75 years;
- A confirmed case of Covid-19. The criteria are as follows:
- Clinically diagnosed or suspected cases with one of the following etiological evidence: 1) SARS-CoV-2 nucleic acid is positive in respiratory or blood samples detected by RT-PCR; 2) virus sequence detected in respiratory or blood samples shares high homology with the known sequence of SARS-CoV-2.
- Clinical classification is severe case: Meet any of the following:
- 1) Increased respiratory rate (≥30 beats / min), difficulty breathing, cyanosis of the lips; 2) Peripheral capillary oxygen saturation (SpO2) ≤93% at rest ; 3)Partial pressure of arterial oxygen (PaO2) / Fraction of inspired oxygen (FiO2) ≤300 mmHg (1mmHg = 0.133kPa).
Who cannot join
- Other types of viral pneumonia, or bacterial pneumonia.
- The clinical classification is mild, moderate or critical;
- Patients with malignant blood or solid tumor.
- Pregnant or lactating women;
- There are other situations or diseases that the investigator think are not suitable to participate in this clinical study or may be increased risk of the subject.
- Patients with serious social and mental disability, inability/restriction of legal capacity;
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- Refusal to sign informed consent;
- Patients with severe liver disease (eg Child Pugh score ≥ C, AST> 5 times upper limit of normal );
- Patients with severe renal insufficiency (estimated glomerular filtration rate ≤30mL / min / 1.73m2) or receiving continuous renal replacement therapy, hemodialysis, peritoneal dialysis.
Trial locations and contacts
1 site in 1 country.
China1 site
Guangzhou Institute of Respiratory Health, The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, 510120
Shiyue Li, MD, 86-20-83062885, lishiyue@188.com
About this study
Official title: Safety and Efficacy of Intravenous Infusion of Bone Marrow-Derived Mesenchymal Stem Cells in Severe Patients With Coronavirus Disease 2019 (COVID-19): A Phase 1/2 Randomized Controlled Trial
Coronavirus Disease 2019 (COVID-19) is spreading worldwide and has become a public health emergency of major international concern. Currently, no specific drugs or vaccines are available. For severe cases, it was found that aberrant pathogenic T cells and inflammatory monocytes are rapidly activated and then producing a large number of cytokines and inducing an inflammatory storm.Mesenchymal stem cells (MSCs) have been shown to possess a comprehensive powerful immunomodulatory function. This study aims to investigate the safety and efficacy of intravenous infusion of mesenchymal stem cells in severe patients with COVID-19.
Read the detailed description
COVID-19 has become a urgent and serious public health event that threatens human life and health globally. No specific pharmacological treatments are available to date for COVID-19.Patients contracting the severe form of the disease constitute approximately 15% of the cases which is characterized by extensive acute inflammation. In these severe cases, there will be rapid respiratory system failure.
MSCs have been employed extensively in cell therapy, which includes a plethora of preclinical research investigations as well as a significant number of clinical trials. Safety and efficacy have been shown in many clinical trials. Previous studies have shown that MSCs could significantly reduce inflammatory cell infiltration in lung tissue, reduce inflammation in lung tissue, and significantly improve lung The structure and function of tissues protect lung tissue from damage.The mechanisms underlying the improvements after MSC infusion in COVID-19 patients also appeared to be the robust antiinflammatory activity of MSCs. Recent studies also showed that intravenous MSC infusion could reduce the overactivation of the immune system and support repair by modulating the lung microenvironment after SARS-CoV-2 infection. MSC therapy inhibiting the overactivation of the immune system and promoting endogenous repair by improving the lung microenvironment after the SARS-CoV-2 infection.
The purpose of this study is to investigate the safety and efficacy of intravenous infusion of mesenchymal stem cells in severe patients With COVID-19.The respiratory function, pulmonary inflammation, clinical symptoms, pulmonary imaging, side effects, immunological characteristics will be evaluated.
- Conditions
- Coronavirus Disease 2019 (COVID-19)
- Being tested
- BM-MSCs, Placebo
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BM-MSCsBiological
Participants will receive conventional treatment plus BM-MSCs(1*10E6 /kg body weight intravenously at Day 1).
PlaceboBiological
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Bone Marrow-Derived Mesenchymal Stem Cells (BM-MSCs) | Experimental | Conventional treatment plus BM-MSCs Receives: Biological: BM-MSCs |
| Placebo | Placebo comparator | Conventional treatment plus placebo Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of oxygenation index (PaO2/FiO2)
Evaluation of pneumonia improvement
Measured: At baseline, 6 hour, Day 1, Day 3,Week 1, Week 2, Week 4, Month 6.
Side effects in the BM-MSCs treatment group
Proportion of participants with treatment-related adverse events
Measured: Baseline through 6 months
Secondary outcomes (7)
Clinical outcome
Improvement of clinical symptoms including duration of fever, respiratory destress, pneumonia, cough, sneezing, diarrhea.
Measured: At baseline, 6 hour, Day 1, Day 3,Week 1, Week 2, Week 4, Month 6.
Hospital stay
days of the patients in hospital
Measured: Baseline through 6 months
CT Scan
Evaluation of pneumonia improvement
Measured: At baseline, 6 hour, Day 1, Day 3,Week 1, Week 2, Week 4, Month 6.
Changes in viral load
(deep sputum / pharyngeal swab / nasal swab / anal swab / tear fluid / stomach fluid / feces / blood or alveolar lavage fluid)
Measured: At baseline, 6 hour, Day 1, Day 3,Week 1, Week 2, Week 4, Month 6.
Changes of CD4+, CD8+ cells count and concentration of cytokines
Immunological status
Measured: At baseline, 6 hour, Day 1, Day 3,Week 1, Week 2, Week 4, Month 6.
Rate of mortality within 28-days
Marker for efficacy
Measured: From baseline to day 28
Changes of C-reactive protein
Markers of Infection
Measured: At baseline, 6 hour, Day 1, Day 3,Week 1, Week 2, Week 4, Month 6.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2020
- Study startApr 2020 (estimated)
- Primary completionDec 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronavirus Disease 2019 (COVID-19)Studies of the same condition, open and under way.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangzhou Institute of Respiratory Disease
- Sponsor type
- University, hospital or other
- Collaborators
- Guangzhou Eighth People's Hospital, Tongji Hospital, GuangZhou Cellgenes Biotechnology Co., Ltd.
- Responsible party
- Principal investigator, ShiYue Li, Guangzhou Institute of Respiratory Disease
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04346368
- Sponsor's protocol ID
- SC-2020-01
- Status last verified
- Apr 2020
- First submitted
- 23 Mar 2020
- Last updated
- 15 Apr 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Jiang Y, Jin J, Ao L, Chen D, Zhang M, Du S, Gao J, Zhu Y, Mao X, Lin Z, Song X, Li S. Safety, feasibility, and exploratory biomarker findings of bone marrow-derived mesenchymal stromal cells in hospitalized severe COVID-19: a phase I/II randomized trial. J Thorac Dis. 2026 Aug 31;18(8):941. doi: 10.21037/jtd-2026-1332. Epub 2026 Aug 28.
PubMed 42724710
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Intravenous Infusion of Bone Marrow-Derived Mesenchymal Stem Cells in Severe Patients With Coronavirus Disease 2019 (COVID-19): A Phase 1/2 Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04346368
- Acronym / sponsor ID
- SC-2020-01
- Conditions
- Coronavirus Disease 2019 (COVID-19)
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Guangzhou Institute of Respiratory DiseaseUniversity, hospital or other
- Collaborators
- Guangzhou Eighth People's Hospital, Tongji Hospital, GuangZhou Cellgenes Biotechnology Co., Ltd.
- Study start
- Apr 2020 (estimated)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 15 Apr 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.
Coronavirus Disease 2019 (COVID-19) is spreading worldwide and has become a public health emergency of major international concern. Currently, no specific drugs or vaccines are available. For severe cases, it was found that aberrant pathogenic T cells and inflammatory monocytes are rapidly activated and then producing a large number of cytokines and inducing an inflammatory storm.Mesenchymal stem cells (MSCs) have been shown to possess a comprehensive powerful immunomodulatory function. This study aims to investigate the safety and efficacy of intravenous infusion of mesenchymal stem cells in severe patients with COVID-19.
Detailed description
COVID-19 has become a urgent and serious public health event that threatens human life and health globally. No specific pharmacological treatments are available to date for COVID-19.Patients contracting the severe form of the disease constitute approximately 15% of the cases which is characterized by extensive acute inflammation. In these severe cases, there will be rapid respiratory system failure.
MSCs have been employed extensively in cell therapy, which includes a plethora of preclinical research investigations as well as a significant number of clinical trials. Safety and efficacy have been shown in many clinical trials. Previous studies have shown that MSCs could significantly reduce inflammatory cell infiltration in lung tissue, reduce inflammation in lung tissue, and significantly improve lung The structure and function of tissues protect lung tissue from damage.The mechanisms underlying the improvements after MSC infusion in COVID-19 patients also appeared to be the robust antiinflammatory activity of MSCs. Recent studies also showed that intravenous MSC infusion could reduce the overactivation of the immune system and support repair by modulating the lung microenvironment after SARS-CoV-2 infection. MSC therapy inhibiting the overactivation of the immune system and promoting endogenous repair by improving the lung microenvironment after the SARS-CoV-2 infection.
The purpose of this study is to investigate the safety and efficacy of intravenous infusion of mesenchymal stem cells in severe patients With COVID-19.The respiratory function, pulmonary inflammation, clinical symptoms, pulmonary imaging, side effects, immunological characteristics will be evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bone Marrow-Derived Mesenchymal Stem Cells (BM-MSCs) | Experimental | Biological: BM-MSCsConventional treatment plus BM-MSCs |
| Placebo | Placebo comparator | Biological: PlaceboConventional treatment plus placebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Willing and able to provide written informed consent prior to performing study procedures
- Age ≥18 years, and ≤75 years;
- Clinically diagnosed or suspected cases with one of the following etiological evidence: 1) SARS-CoV-2 nucleic acid is positive in respiratory or blood samples detected by RT-PCR; 2) virus sequence detected in respiratory or blood samples shares high homology with the known sequence of SARS-CoV-2.
- Clinical classification is severe case: Meet any of the following:
- 1) Increased respiratory rate (≥30 beats / min), difficulty breathing, cyanosis of the lips; 2) Peripheral capillary oxygen saturation (SpO2) ≤93% at rest ; 3)Partial pressure of arterial oxygen (PaO2) / Fraction of inspired oxygen (FiO2) ≤300 mmHg (1mmHg = 0.133kPa).
Key exclusion criteria (9 listed)
- Other types of viral pneumonia, or bacterial pneumonia.
- The clinical classification is mild, moderate or critical;
- Patients with malignant blood or solid tumor.
- Pregnant or lactating women;
- There are other situations or diseases that the investigator think are not suitable to participate in this clinical study or may be increased risk of the subject.
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 |
|---|---|---|
| BM-MSCsParticipants will receive conventional treatment plus BM-MSCs(1*10E6 /kg body weight intravenously at Day 1). | Biological | Bone Marrow-Derived Mesenchymal Stem Cells (BM-MSCs) |
| PlaceboPlacebo | Biological | Placebo |
Primary outcome
Changes of oxygenation index (PaO2/FiO2)
Time frame: At baseline, 6 hour, Day 1, Day 3,Week 1, Week 2, Week 4, Month 6.
Evaluation of pneumonia improvement
Side effects in the BM-MSCs treatment group
Time frame: Baseline through 6 months
Proportion of participants with treatment-related adverse events
7 secondary outcomes
Clinical outcome
Time frame: At baseline, 6 hour, Day 1, Day 3,Week 1, Week 2, Week 4, Month 6.
Hospital stay
Time frame: Baseline through 6 months
CT Scan
Time frame: At baseline, 6 hour, Day 1, Day 3,Week 1, Week 2, Week 4, Month 6.
Changes in viral load
Time frame: At baseline, 6 hour, Day 1, Day 3,Week 1, Week 2, Week 4, Month 6.
Changes of CD4+, CD8+ cells count and concentration of cytokines
Time frame: At baseline, 6 hour, Day 1, Day 3,Week 1, Week 2, Week 4, Month 6.
Rate of mortality within 28-days
Time frame: From baseline to day 28
Changes of C-reactive protein
Time frame: At baseline, 6 hour, Day 1, Day 3,Week 1, Week 2, Week 4, Month 6.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2020.
- Derived from this study: PubMed 42724710Jiang Y, Jin J, Ao L, Chen D, Zhang M, Du S, Gao J, Zhu Y, Mao X, Lin Z, Song X, Li S. Safety, feasibility, and exploratory biomarker findings of bone marrow-derived mesenchymal stromal cells in hospitalized severe COVID-19: a phase I/II randomized trial. J Thorac Dis. 2026 Aug 31;18(8):941. doi: 10.21037/jtd-2026-1332. Epub 2026 Aug 28.
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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 Phase 1/2 study testing BM-MSCs in people with Coronavirus Disease 2019 (COVID-19), run by Guangzhou Institute of Respiratory Disease 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 6 inclusion and 9 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 15 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Shiyue Li, MD (86-20-83062885, lishiyue@188.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes of oxygenation index (PaO2/FiO2) (time frame: At baseline, 6 hour, Day 1, Day 3,Week 1, Week 2, Week 4, Month 6.). 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?
On the ClinicalTrials.gov record for NCT04346368, which also lists 1 linked publication.
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 15 Apr 2020.