Corona Virus Disease 2019(COVID-19)Phase 2NCT04288102
Treatment With Human Umbilical Cord-derived Mesenchymal Stem Cells for Severe Corona Virus Disease 2019 (COVID-19)
A Phase 2 study testing UC-MSCs and Saline containing 1% Human serum albumin（solution without UC-MSCs） in people with Corona Virus Disease 2019(COVID-19), run by Beijing 302 Hospital at 3 sites in China.
Trial summary
COVID-19 caused clusters of severe respiratory illness and was associated with 2% mortality. No specific anti-viral treatment exists. The mainstay of clinical management is largely symptomatic treatment, with organ support in intensive care for seriously ill patients. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Corona Virus Disease 2019(COVID-19)
- What is being tested?
- UC-MSCs and Saline containing 1% Human serum albumin（solution without UC-MSCs）
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 3 sitesChina
- Study dates
- 5 Mar 2020to 9 Jul 2020
- Phase
- Phase 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
- Male or female, aged at 18 years (including) -75 years old
- Hospitalized
- Laboratory confirmation of SARS-CoV-2 infection by reverse-transcription polymerase chain reaction (RT-PCR) from any diagnostic sampling source
- Pneumonia that is judged by computed tomography
- In accordance with any one of the following : 1)dyspnea (RR ≥ 30 times / min), 2)finger oxygen saturation ≤ 93% in resting state, 3)arterial oxygen partial pressure (PaO2) / oxygen absorption concentration (FiO2) ≤ 300MMHG, 4)pulmonary imaging shows that the focus progress > 50% in 24-48 hours
- Interstitial lung damage is judged by computed tomography.
Who cannot join
- Pregnancy, lactation and those who are not pregnant but do not take effective contraceptives measures;
- Patients with malignant tumor, other serious systemic diseases and psychosis;
- Patients who are participating in other clinical trials;
- Inability to provide informed consent or to comply with test requirements.
- Co-Infection of HIV, tuberculosis, influenza virus, adenovirus and other respiratory infection virus.
- Invasive ventilation
Show all 10Show fewer
- Shock
- Combined with other organ failure( need organ support)
- Interstitial lung damage caused by other reasons ( in 2 weeks)
- The pulmonary imaging revealed the interstitial damage of lungs before the COVID-19 confirmed.
Trial locations and contacts
3 sites in 1 country.
China3 sites
General Hospital of Central Theater Command
Wuhan, Hubei, 430000
Maternal and Child Hospital of Hubei Province
Wuhan, Hubei, 430000
Wuhan Huoshenshan Hospital
Wuhan, Hubei, 430000
About this study
Official title: A Phase II, Multicenter, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Efficacy and Safety of Human Umbilical Cord-derived Mesenchymal Stem Cells in the Treatment of Severe COVID-19 Patients
COVID-19 caused clusters of severe respiratory illness and was associated with 2% mortality. No specific anti-viral treatment exists. The mainstay of clinical management is largely symptomatic treatment, with organ support in intensive care for seriously ill patients. Cellular therapy, using mesenchymal stem cells has been shown to reduce nonproductive inflammation and affect tissue regeneration and is being evaluated in patients with ARDS. This clinical trial is to inspect the safety and efficiency of mesenchymal stem cells (MSCs) therapy for severe COVID-19.
Read the detailed description
The Corona Virus Disease 2019 (COVID-19) caused by severe acute respiratory syndrome corona virus 2 (SARS-CoV-2) infection has unprecedentedly spread in the worldwide and been declared as a pandemic by the world health organization. COVID-19 is characterized by sustained cytokines production and hyper-inflammation, can cause clusters of severe respiratory illness with a fatality rate around 2-5%. There are currently no prophylactic vaccine and no specific antiviral treatment agents available recommended for COVID-19. Therefore, it is urgent to find a safe and effective therapeutic approach to COVID-19.
During the last decade, the promising features of mesenchymal stem cells (MSCs), including their regenerative properties and ability to differentiate into diverse cell lineages, have generated great interest among researchers whose work has offered intriguing perspectives on cell-based therapies for various diseases. These findings seem to highlight that the beneficial effect of MSC-based treatment could be principally due by the immunomodulation and regenerative potential of these cells. MSCs could significantly reduce the pathological changes of lung and inhibit the cell-mediated immune inflammatory response induced by influenza virus in animal model . MSCs has been shown to reduce nonproductive inflammation and affect tissue regeneration and is being evaluated in patients with ARDS. Our phase I preliminary data of parallel assignment study(NCT04252118) showed that three doses of MSCs was safe in patients with COVID-19. Randomized control trial is needed to assess efficacy and safety.
The investigators will do a prospective, double-blind, multicentre, randomised trial to assess treatment with three intravenous doses of MSCs compared with placebo. 90 severe COVID-19 patients will be recruited in China. 60 patients will receive i.v. transfusion 3 times of MSCs (4.0*10E7 cells per time) and the standard of care as the treated group. In addition, the 30 patients will receive placebo and standard of care as control group.
Change in lesion proportion (%) of full lung volume from baseline to day 10, day28 and 90, change in consolidation/ ground-glass lesion proportion (%) of full lung volume from baseline to day 10, 28 and 90, time to clinical improvement in 28 days, mMRC (Modified Medical Research Council) dyspnea scale, 6-minute walk test, maximum vital capacity (VCmax), Diffusing Capacity (DLCO), oxygen saturation, oxygenation index, duration of oxygen therapy, side effects, immunological characteristics (immune cells, inflammatory factors, etc.) will be evaluated during the 90 days follow up.
- Conditions
- Corona Virus Disease 2019(COVID-19)
- Being tested
- UC-MSCs, Saline containing 1% Human serum albumin（solution without UC-MSCs）
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UC-MSCsBiological
3 does of UC-MSCs(4.0*10E7 cells per time) intravenously at Day 0, Day 3, Day 6.
Saline containing 1% Human serum albumin（solution without UC-MSCs）Biological
3 does of placebo（intravenously at Day 0, Day 3, Day 6）
| Study group | Role | What they receive |
|---|---|---|
| Human Umbilical Cord-Mesenchymal Stem Cells (UC-MSCs) | Experimental | Participants will receive standard of care plus 3 does of UC-MSCs Receives: Biological: UC-MSCs |
| Placebo | Placebo comparator | Participants will receive standard of care plus 3 does of placebo Receives: Biological: Saline containing 1% Human serum albumin（solution without UC-MSCs） |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in lesion proportion (%) of full lung volume from baseline to day 28.
Evaluation of Pneumonia Improvement
Measured: Day 28
Secondary outcomes (19)
Change in lesion proportion (%) of full lung volume from baseline to day 10 and 90
Evaluation of Pneumonia Improvement
Measured: Day 10, Day 90
Change in consolidation lesion proportion (%) of full lung volume from baseline to day 10, 28 and 90.
Evaluation of Pneumonia Improvement
Measured: Day 10, Day 28, Day 90
Change in ground-glass lesion proportion (%) of full lung volume from baseline to day 10, 28 and 90.
Evaluation of Pneumonia Improvement
Measured: Day 10, Day 28, Day 90
Pulmonary fibrosis - related morphological features in CT scan at day 90 a. cord-like shadow b. honeycomb-like shadows c. interlobular septal thickening d. intralobular interstitial thickening e. pleural thickening
Evaluation of Pneumonia Improvement
Measured: Day 90
Lung densitometry: Change in total voxel 'weight' in lesion area voxel 'weight'=voxel density (in HU) × voxel volume (in voxel)
Evaluation of Pneumonia Improvement
Measured: Day 10, Day 28, Day 90
Lung densitometry: volumes histogram of lung density distribution (<-750, -750~-300, -300~50, >50) at day 10, 28 and 90.
Evaluation of Pneumonia Improvement
Measured: Day 10, Day 28, Day 90
Time to clinical improvement in 28 days.
Clinical improvement defined as a one-point deduction from baseline in a 6 ordinal scale:
- Not hospitalized;
- Hospitalized, not requiring supplemental oxygen;
- Hospitalized, requiring supplemental oxygen;
- Hospitalized, on non-invasive ventilation or high flow oxygen devices;
- Hospitalized, on invasive mechanical ventilation or ECMO;
- Death.
Measured: Day 28
Oxygenation index( PaO2/FiO2)
Evaluation of Pneumonia Improvement
Measured: Day 6, Day 10, Day 28
Duration of oxygen therapy(days)
Evaluation of Pneumonia Improvement
Measured: Day 28, Day 90
Blood oxygen saturation
Evaluation of Pneumonia Improvement
Measured: Day 6, Day 10, Day 28
6-minute walk test
Evaluation of Pneumonia Improvement
Measured: Day 28, Day 90
Maximum vital capacity (VCmax)
Evaluation of Pneumonia Improvement
Measured: Baseline, Day 10, Day 14, Day 21, Day 28, Day 90
Diffusing Capacity (DLCO)
Evaluation of Pneumonia Improvement
Measured: Baseline, Day 10, Day 14, Day 21, Day 28, Day 90
mMRC (Modified Medical Research Council) dyspnea scale
Evaluation of Pneumonia Improvement
No limitation of activities, discharged from hospital =Score 1; Hospitalized, no oxygen therapy=Score 2; Oxygen by mask or nasal prongs-Score 3; Non-invasive ventilation or high-flow oxygen=Score 4; Mechanical ventilation or ECMO=Score 5; Death=Score 6.
Measured: Day 28, Day 90
Changes of absolute lymphocyte counts and subsets from baseline to day 6, 10, 28 and 90.
Marker of Immunological function
Measured: Day 6, Day 10, Day 28, Day 90
Changes of cytokine/chemokine levels from baseline to day 6, 10, 28 and 90.
Marker of Immunological function
Measured: Day 6, Day 10, Day 28, Day 90
Adverse events
Safety endpoints
Measured: Day 0 through Day 90
Serious adverse events
Safety endpoints
Measured: Day 0 through Day 90
All-cause mortality
Safety endpoints
Measured: Day 0 through Day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2020
- Study start5 Mar 2020
- Primary completion12 May 2020
- Study completion9 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Corona Virus 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, double-blind, placebo-controlled study
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing 302 Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Huoshenshan Hospital, Maternal and Child Health Hospital of Hubei Province, The General Hospital of Central Theater Command, Vcanbio Cell and Gene Engineering Corp., Ltd.
- Responsible party
- Principal investigator, Fu-Sheng Wang, Beijing 302 Hospital
- Investigators
- Fu-Sheng Wang, MD, PhD, Study chair, Beijing 302 Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04288102
- Sponsor's protocol ID
- 2020-013-D
- Status last verified
- Aug 2020
- First submitted
- 24 Feb 2020
- Last updated
- 19 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: After approval from the steering committee and the Human Genetic Resources Administration of China, this trial data can be shared with qualifying researchers who submit a proposal with a valuable research question. A contract should be signed.
Publications
Yuan MQ, Song L, Wang ZR, Zhang ZY, Shi M, He J, Mo Q, Zheng N, Yao WQ, Zhang Y, Dong T, Li Y, Zhang C, Song J, Huang L, Xu Z, Yuan X, Fu JL, Zhen C, Cai J, Dong J, Zhang J, Xie WF, Li Y, Zhang B, Shi L, Wang FS. Long-term outcomes of mesenchymal stem cell therapy in severe COVID-19 patients: 3-year follow-up of a randomized, double-blind, placebo-controlled trial. Stem Cell Res Ther. 2025 Feb 25;16(1):94. doi: 10.1186/s13287-025-04148-1.
PubMed 40001244Li TT, Zhang B, Fang H, Shi M, Yao WQ, Li Y, Zhang C, Song J, Huang L, Xu Z, Yuan X, Fu JL, Zhen C, Zhang Y, Wang ZR, Zhang ZY, Yuan MQ, Dong T, Bai R, Zhao L, Cai J, Dong J, Zhang J, Xie WF, Li Y, Shi L, Wang FS. Human mesenchymal stem cell therapy in severe COVID-19 patients: 2-year follow-up results of a randomized, double-blind, placebo-controlled trial. EBioMedicine. 2023 Jun;92:104600. doi: 10.1016/j.ebiom.2023.104600. Epub 2023 May 5.
PubMed 37149930Shi L, Yuan X, Yao W, Wang S, Zhang C, Zhang B, Song J, Huang L, Xu Z, Fu JL, Li Y, Xu R, Li TT, Dong J, Cai J, Li G, Xie Y, Shi M, Li Y, Zhang Y, Xie WF, Wang FS. Human mesenchymal stem cells treatment for severe COVID-19: 1-year follow-up results of a randomized, double-blind, placebo-controlled trial. EBioMedicine. 2022 Jan;75:103789. doi: 10.1016/j.ebiom.2021.103789. Epub 2021 Dec 25.
PubMed 34963099Shi L, Huang H, Lu X, Yan X, Jiang X, Xu R, Wang S, Zhang C, Yuan X, Xu Z, Huang L, Fu JL, Li Y, Zhang Y, Yao WQ, Liu T, Song J, Sun L, Yang F, Zhang X, Zhang B, Shi M, Meng F, Song Y, Yu Y, Wen J, Li Q, Mao Q, Maeurer M, Zumla A, Yao C, Xie WF, Wang FS. Effect of human umbilical cord-derived mesenchymal stem cells on lung damage in severe COVID-19 patients: a randomized, double-blind, placebo-controlled phase 2 trial. Signal Transduct Target Ther. 2021 Feb 10;6(1):58. doi: 10.1038/s41392-021-00488-5.
PubMed 33568628
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Multicenter, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Efficacy and Safety of Human Umbilical Cord-derived Mesenchymal Stem Cells in the Treatment of Severe COVID-19 Patients
- ClinicalTrials.gov ID
- NCT04288102
- Acronym / sponsor ID
- 2020-013-D
- Conditions
- Corona Virus Disease 2019(COVID-19)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Beijing 302 HospitalUniversity, hospital or other
- Collaborators
- Huoshenshan Hospital, Maternal and Child Health Hospital of Hubei Province, The General Hospital of Central Theater Command, Vcanbio Cell and Gene Engineering Corp., Ltd.
- Study start
- 5 Mar 2020 (actual)
- Primary completion
- 12 May 2020 (actual)
- Study completion
- 9 Jul 2020 (actual)
- First posted
- 28 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.
COVID-19 caused clusters of severe respiratory illness and was associated with 2% mortality. No specific anti-viral treatment exists. The mainstay of clinical management is largely symptomatic treatment, with organ support in intensive care for seriously ill patients. Cellular therapy, using mesenchymal stem cells has been shown to reduce nonproductive inflammation and affect tissue regeneration and is being evaluated in patients with ARDS. This clinical trial is to inspect the safety and efficiency of mesenchymal stem cells (MSCs) therapy for severe COVID-19.
Detailed description
The Corona Virus Disease 2019 (COVID-19) caused by severe acute respiratory syndrome corona virus 2 (SARS-CoV-2) infection has unprecedentedly spread in the worldwide and been declared as a pandemic by the world health organization. COVID-19 is characterized by sustained cytokines production and hyper-inflammation, can cause clusters of severe respiratory illness with a fatality rate around 2-5%. There are currently no prophylactic vaccine and no specific antiviral treatment agents available recommended for COVID-19. Therefore, it is urgent to find a safe and effective therapeutic approach to COVID-19.
During the last decade, the promising features of mesenchymal stem cells (MSCs), including their regenerative properties and ability to differentiate into diverse cell lineages, have generated great interest among researchers whose work has offered intriguing perspectives on cell-based therapies for various diseases. These findings seem to highlight that the beneficial effect of MSC-based treatment could be principally due by the immunomodulation and regenerative potential of these cells. MSCs could significantly reduce the pathological changes of lung and inhibit the cell-mediated immune inflammatory response induced by influenza virus in animal model . MSCs has been shown to reduce nonproductive inflammation and affect tissue regeneration and is being evaluated in patients with ARDS. Our phase I preliminary data of parallel assignment study(NCT04252118) showed that three doses of MSCs was safe in patients with COVID-19. Randomized control trial is needed to assess efficacy and safety.
The investigators will do a prospective, double-blind, multicentre, randomised trial to assess treatment with three intravenous doses of MSCs compared with placebo. 90 severe COVID-19 patients will be recruited in China. 60 patients will receive i.v. transfusion 3 times of MSCs (4.0*10E7 cells per time) and the standard of care as the treated group. In addition, the 30 patients will receive placebo and standard of care as control group.
Change in lesion proportion (%) of full lung volume from baseline to day 10, day28 and 90, change in consolidation/ ground-glass lesion proportion (%) of full lung volume from baseline to day 10, 28 and 90, time to clinical improvement in 28 days, mMRC (Modified Medical Research Council) dyspnea scale, 6-minute walk test, maximum vital capacity (VCmax), Diffusing Capacity (DLCO), oxygen saturation, oxygenation index, duration of oxygen therapy, side effects, immunological characteristics (immune cells, inflammatory factors, etc.) will be evaluated during the 90 days follow up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, double-blind, placebo-controlled study
| Arm | Type | Receives |
|---|---|---|
| Human Umbilical Cord-Mesenchymal Stem Cells (UC-MSCs) | Experimental | Biological: UC-MSCsParticipants will receive standard of care plus 3 does of UC-MSCs |
| Placebo | Placebo comparator | Biological: Saline containing 1% Human serum albumin（solution without UC-MSCs）Participants will receive standard of care plus 3 does of 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)
- Male or female, aged at 18 years (including) -75 years old
- Hospitalized
- Laboratory confirmation of SARS-CoV-2 infection by reverse-transcription polymerase chain reaction (RT-PCR) from any diagnostic sampling source
- Pneumonia that is judged by computed tomography
- In accordance with any one of the following : 1)dyspnea (RR ≥ 30 times / min), 2)finger oxygen saturation ≤ 93% in resting state, 3)arterial oxygen partial pressure (PaO2) / oxygen absorption concentration (FiO2) ≤ 300MMHG, 4)pulmonary imaging shows that the focus progress > 50% in 24-48 hours
Key exclusion criteria (10 listed)
- Pregnancy, lactation and those who are not pregnant but do not take effective contraceptives measures;
- Patients with malignant tumor, other serious systemic diseases and psychosis;
- Patients who are participating in other clinical trials;
- Inability to provide informed consent or to comply with test requirements.
- Co-Infection of HIV, tuberculosis, influenza virus, adenovirus and other respiratory infection virus.
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-MSCs3 does of UC-MSCs(4.0*10E7 cells per time) intravenously at Day 0, Day 3, Day 6. | Biological | Human Umbilical Cord-Mesenchymal Stem Cells (UC-MSCs) |
| Saline containing 1% Human serum albumin（solution without UC-MSCs）3 does of placebo（intravenously at Day 0, Day 3, Day 6） | Biological | Placebo |
Primary outcome
Change in lesion proportion (%) of full lung volume from baseline to day 28.
Time frame: Day 28
Evaluation of Pneumonia Improvement
19 secondary outcomes
Change in lesion proportion (%) of full lung volume from baseline to day 10 and 90
Time frame: Day 10, Day 90
Change in consolidation lesion proportion (%) of full lung volume from baseline to day 10, 28 and 90.
Time frame: Day 10, Day 28, Day 90
Change in ground-glass lesion proportion (%) of full lung volume from baseline to day 10, 28 and 90.
Time frame: Day 10, Day 28, Day 90
Pulmonary fibrosis - related morphological features in CT scan at day 90 a. cord-like shadow b. honeycomb-like shadows c. interlobular septal thickening d. intralobular interstitial thickening e. pleural thickening
Time frame: Day 90
Lung densitometry: Change in total voxel 'weight' in lesion area voxel 'weight'=voxel density (in HU) × voxel volume (in voxel)
Time frame: Day 10, Day 28, Day 90
Lung densitometry: volumes histogram of lung density distribution (<-750, -750~-300, -300~50, >50) at day 10, 28 and 90.
Time frame: Day 10, Day 28, Day 90
Time to clinical improvement in 28 days.
Time frame: Day 28
Oxygenation index( PaO2/FiO2)
Time frame: Day 6, Day 10, Day 28
Duration of oxygen therapy(days)
Time frame: Day 28, Day 90
Blood oxygen saturation
Time frame: Day 6, Day 10, Day 28
6-minute walk test
Time frame: Day 28, Day 90
Maximum vital capacity (VCmax)
Time frame: Baseline, Day 10, Day 14, Day 21, Day 28, Day 90
Diffusing Capacity (DLCO)
Time frame: Baseline, Day 10, Day 14, Day 21, Day 28, Day 90
mMRC (Modified Medical Research Council) dyspnea scale
Time frame: Day 28, Day 90
Changes of absolute lymphocyte counts and subsets from baseline to day 6, 10, 28 and 90.
Time frame: Day 6, Day 10, Day 28, Day 90
Changes of cytokine/chemokine levels from baseline to day 6, 10, 28 and 90.
Time frame: Day 6, Day 10, Day 28, Day 90
Adverse events
Time frame: Day 0 through Day 90
Serious adverse events
Time frame: Day 0 through Day 90
All-cause mortality
Time frame: Day 0 through Day 90
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2020.
- Derived from this study: PubMed 40001244Yuan MQ, Song L, Wang ZR, Zhang ZY, Shi M, He J, Mo Q, Zheng N, Yao WQ, Zhang Y, Dong T, Li Y, Zhang C, Song J, Huang L, Xu Z, Yuan X, Fu JL, Zhen C, Cai J, Dong J, Zhang J, Xie WF, Li Y, Zhang B, Shi L, Wang FS. Long-term outcomes of mesenchymal stem cell therapy in severe COVID-19 patients: 3-year follow-up of a randomized, double-blind, placebo-controlled trial. Stem Cell Res Ther. 2025 Feb 25;16(1):94. doi: 10.1186/s13287-025-04148-1.
- Derived from this study: PubMed 37149930Li TT, Zhang B, Fang H, Shi M, Yao WQ, Li Y, Zhang C, Song J, Huang L, Xu Z, Yuan X, Fu JL, Zhen C, Zhang Y, Wang ZR, Zhang ZY, Yuan MQ, Dong T, Bai R, Zhao L, Cai J, Dong J, Zhang J, Xie WF, Li Y, Shi L, Wang FS. Human mesenchymal stem cell therapy in severe COVID-19 patients: 2-year follow-up results of a randomized, double-blind, placebo-controlled trial. EBioMedicine. 2023 Jun;92:104600. doi: 10.1016/j.ebiom.2023.104600. Epub 2023 May 5.
- Derived from this study: PubMed 34963099Shi L, Yuan X, Yao W, Wang S, Zhang C, Zhang B, Song J, Huang L, Xu Z, Fu JL, Li Y, Xu R, Li TT, Dong J, Cai J, Li G, Xie Y, Shi M, Li Y, Zhang Y, Xie WF, Wang FS. Human mesenchymal stem cells treatment for severe COVID-19: 1-year follow-up results of a randomized, double-blind, placebo-controlled trial. EBioMedicine. 2022 Jan;75:103789. doi: 10.1016/j.ebiom.2021.103789. Epub 2021 Dec 25.
- Derived from this study: PubMed 33568628Shi L, Huang H, Lu X, Yan X, Jiang X, Xu R, Wang S, Zhang C, Yuan X, Xu Z, Huang L, Fu JL, Li Y, Zhang Y, Yao WQ, Liu T, Song J, Sun L, Yang F, Zhang X, Zhang B, Shi M, Meng F, Song Y, Yu Y, Wen J, Li Q, Mao Q, Maeurer M, Zumla A, Yao C, Xie WF, Wang FS. Effect of human umbilical cord-derived mesenchymal stem cells on lung damage in severe COVID-19 patients: a randomized, double-blind, placebo-controlled phase 2 trial. Signal Transduct Target Ther. 2021 Feb 10;6(1):58. doi: 10.1038/s41392-021-00488-5.
- Individual participant dataSharing planned: Yes. After approval from the steering committee and the Human Genetic Resources Administration of China, this trial data can be shared with qualifying researchers who submit a proposal with a valuable research question. A contract should be signed.
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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.
Fu-Sheng Wang, MD, PhD study chair
Beijing 302 Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing UC-MSCs and Saline containing 1% Human serum albumin（solution without UC-MSCs） in people with Corona Virus Disease 2019(COVID-19), run by Beijing 302 Hospital at 3 sites 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 10 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: finished, as of the sponsor's last update on 19 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 phase mean?
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in lesion proportion (%) of full lung volume from baseline to day 28. (time frame: Day 28). 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 NCT04288102, which also lists 4 linked publications.
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 19 Aug 2020.