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Bone Marrow-Derived Mesenchymal Stem Cell Treatment for Severe Patients With Coronavirus Disease 2019 (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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04346368
Recruitment Status : Unknown
Verified April 2020 by ShiYue Li, Guangzhou Institute of Respiratory Disease.
Recruitment status was:  Not yet recruiting
First Posted : April 15, 2020
Last Update Posted : April 15, 2020
Sponsor:
Collaborators:
Guangzhou Eighth People's Hospital
Tongji Hospital
Guangzhou Cellgenes Biotechnology Co.,Ltd
Information provided by (Responsible Party):
ShiYue Li, Guangzhou Institute of Respiratory Disease

Tracking Information
First Submitted Date  ICMJE March 23, 2020
First Posted Date  ICMJE April 15, 2020
Last Update Posted Date April 15, 2020
Estimated Study Start Date  ICMJE April 2020
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 13, 2020)
  • Changes of oxygenation index (PaO2/FiO2) [ Time Frame: At baseline, 6 hour, Day 1, Day 3,Week 1, Week 2, Week 4, Month 6. ]
    Evaluation of pneumonia improvement
  • Side effects in the BM-MSCs treatment group [ Time Frame: Baseline through 6 months ]
    Proportion of participants with treatment-related adverse events
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: April 13, 2020)
  • Clinical outcome [ Time Frame: At baseline, 6 hour, Day 1, Day 3,Week 1, Week 2, Week 4, Month 6. ]
    Improvement of clinical symptoms including duration of fever, respiratory destress, pneumonia, cough, sneezing, diarrhea.
  • Hospital stay [ Time Frame: Baseline through 6 months ]
    days of the patients in hospital
  • CT Scan [ Time Frame: At baseline, 6 hour, Day 1, Day 3,Week 1, Week 2, Week 4, Month 6. ]
    Evaluation of pneumonia improvement
  • Changes in viral load [ Time Frame: At baseline, 6 hour, Day 1, Day 3,Week 1, Week 2, Week 4, Month 6. ]
    (deep sputum / pharyngeal swab / nasal swab / anal swab / tear fluid / stomach fluid / feces / blood or alveolar lavage fluid)
  • Changes of CD4+, CD8+ cells count and concentration of cytokines [ Time Frame: At baseline, 6 hour, Day 1, Day 3,Week 1, Week 2, Week 4, Month 6. ]
    Immunological status
  • Rate of mortality within 28-days [ Time Frame: From baseline to day 28 ]
    Marker for efficacy
  • Changes of C-reactive protein [ Time Frame: At baseline, 6 hour, Day 1, Day 3,Week 1, Week 2, Week 4, Month 6. ]
    Markers of Infection
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Bone Marrow-Derived Mesenchymal Stem Cell Treatment for Severe Patients With Coronavirus Disease 2019 (COVID-19)
Official Title  ICMJE Safety and Efficacy of Intravenous Infusion of Bone Marrow-Derived Mesenchymal Stem Cells in Severe Patients With Coronavirus Disease 2019 (COVID-19): A Phase 1/2 Randomized Controlled Trial
Brief Summary Coronavirus Disease 2019 (COVID-19) is spreading worldwide and has become a public health emergency of major international concern. Currently, no specific drugs or vaccines are available. For severe cases, it was found that aberrant pathogenic T cells and inflammatory monocytes are rapidly activated and then producing a large number of cytokines and inducing an inflammatory storm.Mesenchymal stem cells (MSCs) have been shown to possess a comprehensive powerful immunomodulatory function. This study aims to investigate the safety and efficacy of intravenous infusion of mesenchymal stem cells in severe patients with COVID-19.
Detailed Description

COVID-19 has become a urgent and serious public health event that threatens human life and health globally. No specific pharmacological treatments are available to date for COVID-19.Patients contracting the severe form of the disease constitute approximately 15% of the cases which is characterized by extensive acute inflammation. In these severe cases, there will be rapid respiratory system failure.

MSCs have been employed extensively in cell therapy, which includes a plethora of preclinical research investigations as well as a significant number of clinical trials. Safety and efficacy have been shown in many clinical trials. Previous studies have shown that MSCs could significantly reduce inflammatory cell infiltration in lung tissue, reduce inflammation in lung tissue, and significantly improve lung The structure and function of tissues protect lung tissue from damage.The mechanisms underlying the improvements after MSC infusion in COVID-19 patients also appeared to be the robust antiinflammatory activity of MSCs. Recent studies also showed that intravenous MSC infusion could reduce the overactivation of the immune system and support repair by modulating the lung microenvironment after SARS-CoV-2 infection. MSC therapy inhibiting the overactivation of the immune system and promoting endogenous repair by improving the lung microenvironment after the SARS-CoV-2 infection.

The purpose of this study is to investigate the safety and efficacy of intravenous infusion of mesenchymal stem cells in severe patients With COVID-19.The respiratory function, pulmonary inflammation, clinical symptoms, pulmonary imaging, side effects, immunological characteristics will be evaluated.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Coronavirus Disease 2019 (COVID-19)
Intervention  ICMJE
  • Biological: BM-MSCs
    Participants will receive conventional treatment plus BM-MSCs(1*10E6 /kg body weight intravenously at Day 1).
  • Biological: Placebo
    Placebo
Study Arms  ICMJE
  • Experimental: Bone Marrow-Derived Mesenchymal Stem Cells (BM-MSCs)
    Conventional treatment plus BM-MSCs
    Intervention: Biological: BM-MSCs
  • Placebo Comparator: Placebo
    Conventional treatment plus placebo
    Intervention: Biological: Placebo
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 Unknown status
Estimated Enrollment  ICMJE
 (submitted: April 13, 2020)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2020
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Willing and able to provide written informed consent prior to performing study procedures
  2. Age ≥18 years, and ≤75 years;

    A confirmed case of Covid-19. The criteria are as follows:

    Clinically diagnosed or suspected cases with one of the following etiological evidence: 1) SARS-CoV-2 nucleic acid is positive in respiratory or blood samples detected by RT-PCR; 2) virus sequence detected in respiratory or blood samples shares high homology with the known sequence of SARS-CoV-2.

  3. Clinical classification is severe case: Meet any of the following:

1) Increased respiratory rate (≥30 beats / min), difficulty breathing, cyanosis of the lips; 2) Peripheral capillary oxygen saturation (SpO2) ≤93% at rest ; 3)Partial pressure of arterial oxygen (PaO2) / Fraction of inspired oxygen (FiO2) ≤300 mmHg (1mmHg = 0.133kPa).

Exclusion Criteria:

  1. Other types of viral pneumonia, or bacterial pneumonia.
  2. The clinical classification is mild, moderate or critical;
  3. Patients with malignant blood or solid tumor.
  4. Pregnant or lactating women;
  5. There are other situations or diseases that the investigator think are not suitable to participate in this clinical study or may be increased risk of the subject.
  6. Patients with serious social and mental disability, inability/restriction of legal capacity;
  7. Refusal to sign informed consent;
  8. Patients with severe liver disease (eg Child Pugh score ≥ C, AST> 5 times upper limit of normal );
  9. Patients with severe renal insufficiency (estimated glomerular filtration rate ≤30mL / min / 1.73m2) or receiving continuous renal replacement therapy, hemodialysis, peritoneal dialysis.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04346368
Other Study ID Numbers  ICMJE SC-2020-01
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 Not Provided
Current Responsible Party ShiYue Li, Guangzhou Institute of Respiratory Disease
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Guangzhou Institute of Respiratory Disease
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE
  • Guangzhou Eighth People's Hospital
  • Tongji Hospital
  • Guangzhou Cellgenes Biotechnology Co.,Ltd
Investigators  ICMJE Not Provided
PRS Account Guangzhou Institute of Respiratory Disease
Verification Date April 2020

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