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

NCT04346368 | Unknown Phase 1

• 1 other identifier: SC-2020-01
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronavirus Disease 2019 (COVID-19)

Outcome Measures

Primary Outcomes (2)

• Changes of oxygenation index (PaO2/FiO2)

  Evaluation of pneumonia improvement

  At baseline, 6 hour, Day 1, Day 3,Week 1, Week 2, Week 4, Month 6.

• Side effects in the BM-MSCs treatment group

  Proportion of participants with treatment-related adverse events

  Baseline through 6 months

Secondary Outcomes (7)

• Clinical outcome

  At baseline, 6 hour, Day 1, Day 3,Week 1, Week 2, Week 4, Month 6.

• Hospital stay

  Baseline through 6 months

• CT Scan

  At baseline, 6 hour, Day 1, Day 3,Week 1, Week 2, Week 4, Month 6.

• Changes in viral load

  At baseline, 6 hour, Day 1, Day 3,Week 1, Week 2, Week 4, Month 6.

• Changes of CD4+, CD8+ cells count and concentration of cytokines

  At baseline, 6 hour, Day 1, Day 3,Week 1, Week 2, Week 4, Month 6.

Study Arms (2)

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

EXPERIMENTAL

Conventional treatment plus BM-MSCs

Biological: BM-MSCs

Placebo

PLACEBO COMPARATOR

Conventional treatment plus placebo

Biological: Placebo

Interventions

BM-MSCs BIOLOGICAL

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

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

Placebo BIOLOGICAL

Placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Willing and able to provide written informed consent prior to performing study procedures
• 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.
• Clinical classification is severe case: Meet any of the following:
• \) 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).

You may not qualify if:

• Other types of viral pneumonia, or bacterial pneumonia.
• The clinical classification is mild, moderate or critical;
• Patients with malignant blood or solid tumor.
• Pregnant or lactating women;
• 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.
• Patients with serious social and mental disability, inability/restriction of legal capacity;
• Refusal to sign informed consent;
• Patients with severe liver disease (eg Child Pugh score ≥ C, AST\> 5 times upper limit of normal );
• Patients with severe renal insufficiency (estimated glomerular filtration rate ≤30mL / min / 1.73m2) or receiving continuous renal replacement therapy, hemodialysis, peritoneal dialysis.

Sponsors & Collaborators

• Guangzhou Institute of Respiratory Disease: lead
• Guangzhou Eighth People's Hospital: collaborator
• Tongji Hospital: collaborator
• Guangzhou Cellgenes Biotechnology Co.,Ltd: collaborator

Study Sites (1)

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

Guangzhou, Guangdong, 510120, China

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Shiyue Li, MD

CONTACT

86-20-83062885; lishiyue@188.com

Ming Liu, MD

CONTACT

86-20-83062885; mingliu128@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 23, 2020
• First Posted: April 15, 2020
• Study Start: April 1, 2020
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: April 15, 2020

Record last verified: 2020-04

Locations

CN (1)