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Umbilical Cord(UC)-Derived Mesenchymal Stem Cells(MSCs) Treatment for the 2019-novel Coronavirus(nCOV) Pneumonia

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: NCT04269525
Recruitment Status : Recruiting
First Posted : February 13, 2020
Last Update Posted : February 17, 2020
Sponsor:
Collaborator:
Tuohua Biological Technology Co. Ltd
Information provided by (Responsible Party):
ZhiYong Peng, Zhongnan Hospital

Brief Summary:
Serious Pneumonia and Critical Pneumonia caused by the 2019-nCOV infection greatly threats patients' life, UC-MSCs treatment has been proved to play a role in curing multiple diseases. And this study is conducted to find out whether or not it will function in 2019-nCOV infection Pneumonia.

Condition or disease Intervention/treatment Phase
Pneumonia, Viral Pneumonia, Ventilator-Associated Biological: UC-MSCs Phase 2

Detailed Description:
Serious Pneumonia and Critical Pneumonia caused by the 2019-nCOV infection greatly threats patients' life, UC-MSCs treatment has been proved to play a role in curing multiple diseases. And this study is conducted to find out whether or not it will function in 2019-nCOV infection Pneumonia. And we are going to get the permission of the enrolled patients. Besides the present clinical treatment, UC-MSCs treatment will be applied to those fulfilling the enrollment. After a period of UC-MSCs treatment, the analysis of UC-MSCs treatment will be completed from related aspects.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Intervention Model Description: reaching the criteria of pneumonia according to Diagnosis and Clinical Management of Pneumonia caused by 2019-nCoV Infection(Trial Version 4)
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Clinical Research Regarding the Availability and Safety of UC-MSCs Treatment for Serious Pneumonia and Critical Pneumonia Caused by the 2019-nCOV Infection
Actual Study Start Date : February 6, 2020
Estimated Primary Completion Date : April 30, 2020
Estimated Study Completion Date : September 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia

Arm Intervention/treatment
Experimental: pneumonia
According to Diagnosis and Clinical Management of Pneumonia caused by 2019-nCoV Infection(Trial Version 4), patients enrolled will be divided to serious pneumonia group or critical pneumonia group. All subjects will receive UC-MSCs 3.3 * 107 cell number / 50ml / bag, 3 bags each time. And UC-MSCs will be infused intravenously on the 1st, 3rd, 5th, and 7th days after enrollment, 1 time each day. The efficacy and safety of the treatment, patients' adverse reactions will be monitored.
Biological: UC-MSCs
After enrollment, each subject will receive UC-MSCs infusion intravenously on day 1, day 3, day 5, and day 7.




Primary Outcome Measures :
  1. Oxygenation index [ Time Frame: on the day 14 after enrollment ]
    partial arterial oxygen pressure (PaO2) / oxygen concentration (FiO2)


Secondary Outcome Measures :
  1. 28 day mortality [ Time Frame: on the day 28 after enrollment ]
    whether the patient survives

  2. Hospital stay [ Time Frame: up to 6 months ]
    days of the patients in hospital

  3. 2019-nCoV nucleic acid test [ Time Frame: on the day 7,14,28 after enrollment ]
    whether or not the 2019-nCoV nucleic acid test is positive

  4. Improvement of lung imaging examinations [ Time Frame: on the day 7,14,28 after enrollment ]
    whether lung imaging examinations show the improvement of the pneumonia

  5. White blood cell count [ Time Frame: on the day 7,14,28 after enrollment ]
    counts of white blood cell in a litre of blood

  6. Lymphocyte count [ Time Frame: on the day 7,14,28 after enrollment ]
    counts of lymphocyte in a litre (L) of blood

  7. Lymphocyte percentage [ Time Frame: on the day 7,14,28 after enrollment ]
    percentage of lymphocyte in white blood cell

  8. Procalcitonin [ Time Frame: on the day 7,14,28 after enrollment ]
    procalcitonin in microgram(ug)/L

  9. interleukin(IL)-2 [ Time Frame: on the day 7,14,28 after enrollment ]
    IL-2 in picogram(pg)/millilitre(mL)

  10. IL-4 [ Time Frame: on the day 7,14,28 after enrollment ]
    IL-4 in pg/mL

  11. IL-6 [ Time Frame: on the day 7,14,28 after enrollment ]
    IL-6 in pg/mL

  12. IL-8 [ Time Frame: on the day 7,14,28 after enrollment ]
    IL-8 in pg/mL

  13. IL-10 [ Time Frame: on the day 7,14,28 after enrollment ]
    IL-10 in pg/mL

  14. tumor necrosis factor(TNF)-α [ Time Frame: on the day 7,14,28 after enrollment ]
    TNF-α in nanogram(ng)/L

  15. γ-interferon(IFN) [ Time Frame: on the day 7,14,28 after enrollment ]
    γ-IFN in a thousand unit (KU)/L



Information from the National Library of Medicine

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.


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18-75 years old ,no gender restriction
  • According to Diagnosis and Clinical Management of Pneumonia caused by 2019-nCoV infection(Trial Version 4), patients are diagnosed with severe or critical 2019-nCoV pneumonia with stay in the ICU of less than 48 hours
  • Women of childbearing age should have a negative blood pregnancy test before the start of dosing and agree to take effective contraceptive measures during the trial until the last follow-up (28 days)
  • Sequential Organ Failure Assessment(SOFA) score between 2-13 point
  • Voluntarily participate in this clinical study and sign a written informed consent. If the patient cannot obtain informed consent, he can authorize his legal representative.

Exclusion Criteria:

  • Liver or kidney SOFA score of more than 3 points;
  • HIV positive
  • Highly allergic constitution or history of severe allergies;
  • Pregnant and lactating women;
  • Patients with malignant tumors;
  • Patients with previous history of pulmonary embolism;
  • Participating in clinical trials of other drugs within 3 months before enrollment.
  • be thought by researchers to be inappropriate to participate in this clinical study.

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): NCT04269525


Contacts
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Contact: XingHuan Wang, professor 18971387168 znyylcsy@126.com
Contact: ZhiYong Peng, professor 18672396028 pengzy5@hotmail.com

Locations
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China, Hubei
Zhongnan Hospital of Wuhan University Recruiting
Wuhan, Hubei, China, 430000
Contact: XingHuan Wang, professor         
Contact: ZhiYong Peng, professor         
Principal Investigator: XingHuan Wang         
Principal Investigator: ZhiYong Peng         
Sponsors and Collaborators
ZhiYong Peng
Tuohua Biological Technology Co. Ltd
Investigators
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Study Chair: XingHuan Wang, professor Wuhan University

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Responsible Party: ZhiYong Peng, professor, Zhongnan Hospital
ClinicalTrials.gov Identifier: NCT04269525    
Other Study ID Numbers: 2020002
First Posted: February 13, 2020    Key Record Dates
Last Update Posted: February 17, 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 ZhiYong Peng, Zhongnan Hospital:
2019-nCOV infection
UC-MSCs Treatment
Additional relevant MeSH terms:
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Pneumonia, Ventilator-Associated
Pneumonia, Viral
Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Cross Infection
Infection
Virus Diseases