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Trial record 1 of 1 for:    NCT04288102
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Treatment With Mesenchymal Stem Cells for Severe Corona Virus Disease 2019(COVID-19)

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ClinicalTrials.gov Identifier: NCT04288102
Recruitment Status : Recruiting
First Posted : February 28, 2020
Last Update Posted : March 23, 2020
Sponsor:
Collaborators:
VCANBIO CELL & GENE ENGINEERING CORP.,LTD, China
Wuhan Huoshenshan Hospital, Wuhan, China
Maternal and Child Health Hospital of Hubei Province
Shenzhen Third People's Hospital
Fifth Affiliated Hospital, Sun Yat-Sen University
Wuhan Union Hospital, China
West China Hospital
Tianjin Haihe Hospital
Information provided by (Responsible Party):
Fu-Sheng Wang, Beijing 302 Hospital

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Corona Virus Disease 2019(COVID-19) Biological: MSCs Biological: Saline containing 1% Human serum albumin(solution of MSC) Phase 1 Phase 2

Detailed Description:

The epidemic of 2019 novel coronavirus (causing the disease Covid-19) has expanded from Wuhan throughout China and is being exported to a growing number of countries, some of which have seen onward transmission. COVID-19 caused clusters of severe respiratory illness and was associated with 2% mortality. There is currently no vaccine and no specific antiviral treatment recommended for COVID-19. About 20% of the patients were severe and the mainstay of clinical management is largely symptomatic treatment, with organ support in intensive care for seriously ill patients. Therefore, it is urgent to find a safe and effective therapeutic approach to COVID-19.

In the last years, 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 are 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 receive i.v. transfusion 3 times of MSCs( 4.0*10E7 cells per time), as the treated group, all of them receive the conventional treatment. In addition, the 30 patients receive placebo and conventional treatment were used as control.

Size of lesion area and severity of pulmonary fibrosis by chest CT, proportion of patients in each classification of clinical critical treatment index, 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Prospective, Randomized, Multi-center Phase 2 Clinical Trial of Mesenchymal Stem Cell(MSC) for the Treatment of Severe Corona Virus Disease 2019(COVID-19)
Actual Study Start Date : March 5, 2020
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Mesenchymal Stem Cells (MSCs)
Conventional treatment plus MSCs Participants will receive conventional treatment plus 3 times of MSCs
Biological: MSCs
3 times of MSCs(4.0*10E7 cells per time) intravenously at Day 0, Day 3, Day 6.

Placebo Comparator: Placebo
Conventional treatment plus placebo Participants will receive conventional treatment plus 3 times of placebo
Biological: Saline containing 1% Human serum albumin(solution of MSC)
3 times of placebo(intravenously at Day 0, Day 3, Day 6)




Primary Outcome Measures :
  1. Size of lesion area and severity of pulmonary fibrosis by chest CT [ Time Frame: At Baseline , Day 6, Day 10, Day 14, Day 28 and Day 90 ]
    Evaluation of Pneumonia Improvement


Secondary Outcome Measures :
  1. Proportion of patients in each classification of clinical critical treatment index [ Time Frame: Baseline , Day 7, Day 14, Day 28, Day 90 ]

    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.


  2. Oxygenation index( PaO2/FiO2) [ Time Frame: Baseline , Day 7, Day 14, Day 28, Day 90 ]
    Evaluation of Pneumonia Improvement

  3. Duration of oxygen therapy(days) [ Time Frame: Day 28, Day 90 ]
    Evaluation of Pneumonia Improvement

  4. Duration of hospitalization(days) [ Time Frame: Day 28, Day 90 ]
    Evaluation of Pneumonia Improvement

  5. Blood oxygen saturation [ Time Frame: Baseline , Day 7, Day 14, Day 28, Day 90 ]
    Evaluation of Pneumonia Improvement

  6. CD4+ T cell count and cytokine level [ Time Frame: Baseline , Day 6, Day 10, Day 14, Day 21, Day 28, Day 90 ]
    Marker of Immunological function

  7. Side effects in the MSCs treatment group [ Time Frame: Baseline , Day 3, Day 6,Day 10, Day 14, Day 21, Day 28, Day 90 ]
    Proportion of participants with treatment-related adverse events as assessed by CTCAE v4.0



Information from the National Library of Medicine

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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:

  1. Male or female, aged at 18 years (including) -75 years old
  2. Laboratory confirmation of SARS-CoV-2 infection by reverse-transcription polymerase chain reaction (RT-PCR) from any diagnostic sampling source
  3. Pneumonia that is judged by computed tomography
  4. 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
  5. Interstitial lung damage is judged by 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.
  6. Invasive ventilation
  7. Shock
  8. Combined with other organ failure( need organ support)
  9. Interstitial lung damage caused by other reasons ( in 2 weeks)
  10. The pulmonary imaging revealed the interstitial damage of lungs before the COVID-19 confirmed.

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): NCT04288102


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

Locations
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China, Hubei
Maternal and Child Hospital of Hubei Province Recruiting
Wuhan, Hubei, China, 430000
Contact: Weifen Xie, MD, PhD         
Wuhan Huoshenshan Hospital Recruiting
Wuhan, Hubei, China, 430000
Contact: Lei Shi, MD, PhD       shilei302@126.com   
Sponsors and Collaborators
Beijing 302 Hospital
VCANBIO CELL & GENE ENGINEERING CORP.,LTD, China
Wuhan Huoshenshan Hospital, Wuhan, China
Maternal and Child Health Hospital of Hubei Province
Shenzhen Third People's Hospital
Fifth Affiliated Hospital, Sun Yat-Sen University
Wuhan Union Hospital, China
West China Hospital
Tianjin Haihe Hospital
Investigators
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Study Chair: Fu-Sheng Wang, MD, PhD The fifth medical center of PLA general hospital

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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: NCT04288102    
Other Study ID Numbers: 2020-013-D
First Posted: February 28, 2020    Key Record Dates
Last Update Posted: March 23, 2020
Last Verified: March 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
Additional relevant MeSH terms:
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Coronavirus Infections
Virus Diseases
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections