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Mesenchymal Stem Cell Treatment for Pneumonia Patients Infected With 2019 Novel Coronavirus

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04252118
Recruitment Status : Recruiting
First Posted : February 5, 2020
Last Update Posted : February 26, 2020
Sponsor:
Collaborators:
Innovative Precision Medicine Group (IPM), Hangzhou, China.
Wuhan Huoshenshan Hospital, Wuhan, China
Tianjin Haihe Hospital
VCANBIO CELL & GENE ENGINEERING CORP.,LTD, China
Shenzhen Third People's Hospital
Fifth Affiliated Hospital, Sun Yat-Sen University
Information provided by (Responsible Party):
Fu-Sheng Wang, Beijing 302 Hospital

Brief Summary:
The 2019 novel coronavirus (2019-nCoV) infection caused clusters of severe respiratory illness similar to severe acute respiratory syndrome coronavirus and was associated with ICU admission and high mortality. There is no confirmed antivirus therapy for people infected 2019-nCoV, 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 Mesenchymal Stem Cells (MSCs) therapy for pneumonia patients infected with 2019-nCoV.

Condition or disease Intervention/treatment Phase
2019 Novel Coronavirus Pneumonia Biological: MSCs Phase 1

Detailed Description:

2019-nCoV 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 2019-nCoV 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 2019-nCoV.

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 2019-nCoV. 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.

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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 2019 Novel Coronavirus
Actual Study Start Date : January 27, 2020
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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).
Biological: MSCs
3 times of MSCs(3.0*10E7 MSCs intravenously at Day 0, Day 3, Day 6).

No Intervention: Conventional Control Group
Without MSCs Therapy but conventional treatment should be received.



Primary Outcome Measures :
  1. 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

  2. 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


Secondary Outcome Measures :
  1. 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

  2. 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 2019-nCoV

  3. Rate of mortality within 28-days [ Time Frame: Day 28 ]
    Marker for efficacy of treatment

  4. 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

  5. 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

  6. 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

  7. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male or female, aged at 18 years (including) -70 years old
  2. Laboratory confirmation of 2019-nCoV infection by reverse-transcription polymerase chain reaction (RT-PCR) from any diagnostic sampling source; and
  3. Pneumonia that is judged by chest radiograph or computed tomography.

Exclusion Criteria:

  1. Pregnancy, lactation and those who are not pregnant but do not take effective contraceptives measures;
  2. Patients with malignant tumor, other serious systemic diseases and psychosis;
  3. Patients who are participating in other clinical trials;
  4. Inability to provide informed consent or to comply with test requirements.
  5. Co-Infection of HIV, tuberculosis, influenza virus, adenovirus and other respiratory infection virus.

Information from the National Library of Medicine

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


Contacts
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Contact: Lei Shi, MD,PhD 86-10-66933333 shilei302@126.com
Contact: Fusheng Wang, MD,PhD 86-10-66933328 fswang302@163.com

Locations
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China
Beijing 302 Military Hospital of China Recruiting
Beijing, China, 100039
Contact: Lei Shi, MD, PhD    86-10-66933333    shilei302@126.com   
Sponsors and Collaborators
Beijing 302 Hospital
Innovative Precision Medicine Group (IPM), Hangzhou, China.
Wuhan Huoshenshan Hospital, Wuhan, China
Tianjin Haihe Hospital
VCANBIO CELL & GENE ENGINEERING CORP.,LTD, China
Shenzhen Third People's Hospital
Fifth Affiliated Hospital, Sun Yat-Sen University

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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: February 26, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Fu-Sheng Wang, Beijing 302 Hospital:
2019 Novel Coronavirus Pneumonia
Safety
Efficiency
Cell Therapy
Mesenchymal stem cell
Additional relevant MeSH terms:
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Coronavirus Infections
Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases