Mesenchymal Stem Cell Treatment for Pneumonia Patients Infected With COVID-19
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| ClinicalTrials.gov Identifier: NCT04252118 |
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Recruitment Status : Unknown
Verified April 2020 by Fu-Sheng Wang, Beijing 302 Hospital.
Recruitment status was: Recruiting
First Posted : February 5, 2020
Last Update Posted : April 15, 2020
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| COVID-19 | Biological: MSCs | Phase 1 |
SARS-CoV-2 infection has become an urgent public health event in China. As of 24:00 on January 26, 2020, there are 2744 confirmed cases and 461 severe cases in China, the number is still increasing. There is currently no vaccine and no specific antiviral treatment recommended for SARS-CoV-2 infection. About 20% of the patients were severe and some died of respiratory failure or multiple organ failure. Therefore, it is urgent to find a safe and effective therapeutic approach to pneumonia patients infected with SARS-CoV-2.
In the last year, 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. The investigators found that infusions of UC-MSC significantly improved liver function in decompensated liver cirrhosis and primary biliary cirrhosis (PBC) patients, increased the survival rate in acute-on-chronic liver failure (ACLF) patients . MSCs could significantly reduce the pathological changes of lung and inhibit the cell-mediated immune inflammatory response induced by influenza virus in animal model .
The purpose of this study is to investigate safety and efficiency of MSCs in treating pneumonia patients infected with SARS-CoV-2. This multi-center trial will recruit 20 patients. 10 patients received i.v. transfusion one round (3 times) of 3.0*10E7 cells of MSCs as the treated group, all of them received the conventional treatment. In addition, the equal 10 patients received conventional treatment were used as control. The clinical symptoms, pulmonary imaging, side effects, 28-days mortality, immunological characteristics (immune cells, inflammatory factors, etc.) will be evaluated during the 180 days follow up.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 20 participants |
| Allocation: | Non-Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Safety and Efficiency of Mesenchymal Stem Cell in Treating Pneumonia Patients Infected With COVID-19 |
| Actual Study Start Date : | January 27, 2020 |
| Estimated Primary Completion Date : | December 2020 |
| Estimated Study Completion Date : | December 2021 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: MSCs Treatment Group
Conventional treatment plus MSCs Participants will receive conventional treatment plus 3 times of MSCs(3.0*10E7 MSCs intravenously at Day 0, Day 3, Day 6).
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Biological: MSCs
3 times of MSCs(3.0*10E7 MSCs intravenously at Day 0, Day 3, Day 6). |
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No Intervention: Conventional Control Group
Without MSCs Therapy but conventional treatment should be received.
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- Size of lesion area by chest radiograph or CT [ Time Frame: At Baseline , Day 3, Day 6, Day 10, Day 14, Day 21，Day 28 ]Evaluation of Pneumonia Improvement
- Side effects in the MSCs treatment group [ Time Frame: At Baseline , Day 3, Day 6, Day 10, Day 14, Day 21, Day 28, Day 90 and Day 180 ]Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
- Improvement of Clinical symptoms including duration of fever and respiratory [ Time Frame: At Baseline , Day 3, Day 6, Day 10, Day 14, Day 21, Day 28 ]Evaluation of Pneumonia Improvement
- Time of nucleic acid turning negative [ Time Frame: At Baseline , Day 3, Day 6, Day 10, Day 14, Day 21, Day 28, Day 90 and Day 180 ]Marker for COVID-19
- Rate of mortality within 28-days [ Time Frame: Day 28 ]Marker for efficacy of treatment
- CD4+ and CD8+ T celll count [ Time Frame: At Baseline , Day 3, Day 6, Day 10, Day 14, Day 21, Day 28, Day 90 and Day 180 ]Marker of Immunological function
- Alanine aminotransferase [ Time Frame: At Baseline , Day 3, Day 6, Day 10, Day 14, Day 21, Day 28, Day 90 and Day 180 ]Markers of organ function
- C-reactive protein [ Time Frame: At Baseline , Day 3, Day 6, Day 10, Day 14, Day 21, Day 28, Day 90 and Day 180 ]Markers of Infection
- Creatine kinase [ Time Frame: At Baseline , Day 3, Day 6, Day 10, Day 14, Day 21, Day 28, Day 90 and Day 180 ]Markers of organ function
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Male or female, aged at 18 years (including) -70 years old
- Confirmed COVID-19 by reverse-transcription polymerase chain reaction (RT-PCR) from any diagnostic sampling source; and
- Pneumonia that is judged by chest radiograph or computed tomography.
Exclusion Criteria:
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04252118
| Contact: Lei Shi, MD,PhD | 86-10-66933333 | shilei302@126.com | |
| Contact: Fusheng Wang, MD,PhD | 86-10-66933328 | fswang302@163.com |
| China | |
| Beijing 302 Military Hospital of China | Recruiting |
| Beijing, China, 100039 | |
| Contact: Lei Shi, MD, PhD 86-10-66933333 shilei302@126.com | |
| Responsible Party: | Fu-Sheng Wang, Head of Treatment and Research Center for Infectious Diseases, Principle Investigator, Clinical Professor, Beijing 302 Hospital |
| ClinicalTrials.gov Identifier: | NCT04252118 |
| Other Study ID Numbers: |
2020003D |
| First Posted: | February 5, 2020 Key Record Dates |
| Last Update Posted: | April 15, 2020 |
| Last Verified: | April 2020 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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COVID-19 Safety Efficiency Cell Therapy Mesenchymal stem cell |
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COVID-19 Pneumonia Pneumonia, Viral Respiratory Tract Infections Infections Virus Diseases |
Coronavirus Infections Coronaviridae Infections Nidovirales Infections RNA Virus Infections Lung Diseases Respiratory Tract Diseases |