Bone Marrow-Derived Mesenchymal Stem Cell Treatment for Severe Patients With Coronavirus Disease 2019 (COVID-19)

NCT ID: NCT04346368

Last Updated: 2020-04-15

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-04-30
• Study Completion Date: 2020-12-31

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.

Conditions

Coronavirus Disease 2019 (COVID-19)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Bone Marrow-Derived Mesenchymal Stem Cells (BM-MSCs)

Conventional treatment plus BM-MSCs

Group Type: EXPERIMENTAL

BM-MSCs

Intervention Type: BIOLOGICAL

Participants will receive conventional treatment plus BM-MSCs(1\*10E6 /kg body weight intravenously at Day 1).

Placebo

Conventional treatment plus placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: BIOLOGICAL

Placebo

Interventions

BM-MSCs

Participants will receive conventional treatment plus BM-MSCs(1\*10E6 /kg body weight intravenously at Day 1).

Intervention Type: BIOLOGICAL

Placebo

Placebo

Intervention Type: BIOLOGICAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Guangzhou Eighth People's Hospital

UNKNOWN

Sponsor Role: collaborator

Tongji Hospital

OTHER

Sponsor Role: collaborator

Guangzhou Cellgenes Biotechnology Co.,Ltd

UNKNOWN

Sponsor Role: collaborator

Guangzhou Institute of Respiratory Disease

OTHER

Sponsor Role: lead

Responsible Party

ShiYue Li

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Guangzhou Institute of Respiratory Health, The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

Countries

China

Central Contacts

Shiyue Li, MD

Role: CONTACT

lishiyue@188.com

86-20-83062885

Ming Liu, MD

Role: CONTACT

mingliu128@hotmail.com

86-20-83062885

Facility Contacts

Shiyue Li, MD

Role: primary

lishiyue@188.com

86-20-83062885

Other Identifiers

SC-2020-01

Identifier Type: -

Identifier Source: org_study_id