Safety and Effectiveness of Mesenchymal Stem Cells in the Treatment of Pneumonia of Coronavirus Disease 2019

NCT04371601 | Unknown Early Phase 1

• 1 other identifier: MSC-CoViD-2020
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The outbreak of coronavirus disease 2019 (COVID-19) at the end of 2019 has seen numerous patients experiencing severe acute lung injury (ALI), which developed into severe respiratory distress syndrome (ARDS). The mortality was as high as 20% -40%. Due to the lack of effective antiviral treatments, supporting treatment is the predominant therapy for COVID-19 pneumonia. Its cure is essentially dependent on the patient's immunity. While the immune system eliminates the virus, numerous inflammatory cytokines are produced and a cytokine storm occurs in severe cases. Mesenchymal stem cells (MSCs) play an important role in injury repair and immune regulation, showing advantageous prospects in the treatment of COVID-19 pneumonia. MSCs prevent cytokine storms by retarding the TNF-α pathway, alleviate sepsis by modulating macrophages, neutrophils, NK cells, DC cells, T lymphocytes and B lymphocytes. After infused, MSCs aggregate in the lungs, improve the lung microenvironment, protect alveolar epithelia, and improve pulmonary fibrosis and pulmonary function.

Conditions

COVID-19 Pneumonia

Outcome Measures

Primary Outcomes (1)

• Changes of oxygenation index (PaO2/FiO2) ,blood gas test

  Improvement of pulmonary function

  12 months

Secondary Outcomes (4)

• Detection of TNF-α levels, IL-10 levels

  1,3,6,12months

• Detection of immune cells that secret cytokines, including CXCR3+, CD4+, CD8+, NK+ cells, and regulatory T cells (CD4 + CD25 + FOXP3 + Treg cells).

  1,3,6,12months

• Changes of oxygenation index (PaO2/FiO2) ,blood gas test

  1,3,6months

• Changes of c-reactive protein and calcitonin

  1,3,6,12months

Study Arms (2)

Control group

ACTIVE COMPARATOR

conventional symptomatic treatments such as antiviral (oseltamivir), hormones, oxygen therapy, mechanical ventilation and other supportive therapies

Drug: Oseltamivir; Drug: hormones; Device: oxygen therapy

Experimental group

EXPERIMENTAL

On the basis of the above-mentioned conventional symptomatic treatment and supportive therapy, umbilical cord mesenchymal stem cells were given at 106/Kg body weight / time, once every 4 days for a total of 4 times. Peripheral intravenous infusion was given within 3 days of first admission

Drug: Oseltamivir; Drug: hormones; Device: oxygen therapy; Procedure: mesenchymal stem cells

Interventions

Oseltamivir DRUG

Oseltamivir capsules

Control group; Experimental group

hormones DRUG

a moderate amount of hormone

Control group; Experimental group

oxygen therapy DEVICE

oxygen therapy,mechanical ventilation and other supportive therapies

Control group; Experimental group

mesenchymal stem cells PROCEDURE

mesenchymal stem cells

Experimental group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients with severe COVID-19 pneumonia
• willing to give informed consent

You may not qualify if:

• patients with mild COVID-19 pneumonia
• liver dysfunction
• concomitant with other active infection
• renal dysfunction
• Heart failure \>grade 2
• pregnant
• history of COPD

Sponsors & Collaborators

• Fuzhou General Hospital: lead

Study Sites (1)

Fuzhou General Hospital

Fuzhou, Fujian, 350025, China

Location

MeSH Terms

Interventions

Oseltamivir; Hormones; Oxygen Inhalation Therapy

Intervention Hierarchy (Ancestors)

Acetamides; Amides; Organic Chemicals; Cyclohexenes; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Respiratory Therapy; Therapeutics

Study Officials

• Jianming Tan Tan, M.D and Ph.D

  Fuzhou General Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Control group: conventional symptomatic treatments such as antiviral (oseltamivir), hormones, oxygen therapy, mechanical ventilation and other supportive therapies; Experimental group: On the basis of the above-mentioned conventional symptomatic treatment and supportive therapy, umbilical cord mesenchymal stem cells were given at 106 / Kg body weight / time, once every 4 days for a total of 4 times. Peripheral intravenous infusion was given within 3 days of first admission.

Study Record Dates

• First Submitted: March 25, 2020
• First Posted: May 1, 2020
• Study Start: March 1, 2020
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2022
• Last Updated: May 1, 2020

Record last verified: 2020-03

Locations

CN (1)