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Mesenchymal Stem Cell Treatment for Pneumonia Patients Infected With COVID-19

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 : April 15, 2020
Sponsor:
Collaborators:
Innovative Precision Medicine Group (IPM), Hangzhou, China.
Huoshenshan Hospital
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

Tracking Information
First Submitted Date  ICMJE January 27, 2020
First Posted Date  ICMJE February 5, 2020
Last Update Posted Date April 15, 2020
Actual Study Start Date  ICMJE January 27, 2020
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 25, 2020)
  • 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
Original Primary Outcome Measures  ICMJE
 (submitted: January 30, 2020)
  • Size of lesion area by chest radiograph [ Time Frame: At Baseline , Day 3, Day 6, Day 10, Day 14, Day 28 ]
    Evaluation of Pneumonia Improvement
  • Improvement of Clinical symptoms including duration of fever and respiratory frequency [ Time Frame: At Baseline , Day 3, Day 6, Day 10, Day 14, Day 28 ]
    Evaluation of Pneumonia Improvement
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 13, 2020)
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: January 30, 2020)
  • Side effects in the MSCs treatment group [ Time Frame: At Baseline , Day 3, Day 6, Day 10, Day 14, Day 28 and Day 90 ]
    Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
  • Time of nucleic acid turning negative [ Time Frame: At Baseline , Day 3, Day 6, Day 10, Day 14, Day 28 and Day 90 ]
    Marker for 2019-nCoV
  • 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 28 and Day 90 ]
    Marker of Immunological function
  • Alanine aminotransferase [ Time Frame: At Baseline , Day 3, Day 6, Day 10, Day 14, Day 28 and Day 90 ]
    Markers of organ function
  • C-reactive protein [ Time Frame: At Baseline , Day 3, Day 6, Day 10, Day 14, Day 28 and Day 90 ]
    Markers of Infection
  • Creatine kinase [ Time Frame: At Baseline , Day 3, Day 6, Day 10, Day 14, Day 28 and Day 90 ]
    Markers of organ function
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Mesenchymal Stem Cell Treatment for Pneumonia Patients Infected With COVID-19
Official Title  ICMJE Safety and Efficiency of Mesenchymal Stem Cell in Treating Pneumonia Patients Infected With COVID-19
Brief Summary The SARS-CoV-2 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 SARS-CoV-2, 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 SARS-CoV-2.
Detailed Description

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  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE COVID-19
Intervention  ICMJE Biological: MSCs
3 times of MSCs(3.0*10E7 MSCs intravenously at Day 0, Day 3, Day 6).
Study Arms  ICMJE
  • 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).
    Intervention: Biological: MSCs
  • No Intervention: Conventional Control Group
    Without MSCs Therapy but conventional treatment should be received.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 25, 2020)
20
Original Estimated Enrollment  ICMJE
 (submitted: January 30, 2020)
40
Estimated Study Completion Date  ICMJE December 2021
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Male or female, aged at 18 years (including) -70 years old
  2. Confirmed COVID-19 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Lei Shi, MD,PhD 86-10-66933333 shilei302@126.com
Contact: Fusheng Wang, MD,PhD 86-10-66933328 fswang302@163.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04252118
Other Study ID Numbers  ICMJE 2020003D
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Fu-Sheng Wang, Beijing 302 Hospital
Study Sponsor  ICMJE Beijing 302 Hospital
Collaborators  ICMJE
  • Innovative Precision Medicine Group (IPM), Hangzhou, China.
  • Huoshenshan Hospital
  • Tianjin Haihe Hospital
  • VCANBIO CELL & GENE ENGINEERING CORP.,LTD, China
  • Shenzhen Third People's Hospital
  • Fifth Affiliated Hospital, Sun Yat-Sen University
Investigators  ICMJE Not Provided
PRS Account Beijing 302 Hospital
Verification Date April 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP