Safety and Feasibility of Allogenic MSC in the Treatment of COVID-19

NCT ID: NCT04467047

Last Updated: 2020-07-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-25
• Study Completion Date: 2020-12-30

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

Coronavirus-19 Disease (COVID-19), caused by the Sars-Cov-2 virus, which occurs as a growing pandemic in early 2020 and currently represents an emergency state worldwide. Several reports have shown that the first step in the pathogenesis of Sars-Cov-2 is the recognition of the angiotensin I converting enzyme (ACE2) receptor by the virus. This ACE2 receptor is widely distributed on the surface of human cells, especially as type II alveolar cells and capillary endothelium, however bone marrow, lymph nodes, thymus and spleen are known as immune cells, such as T and lymphocytes. B and macrophages, are negatives to ACE2. These results suggest that immunotherapy can be used to treat infected patients. However, an immunomodulatory capacity cannot be so strong, if just one or two major immunological factors used, as the virus can cause a "cytokine storm", such as IL-2, IL-6, IL-7, GSCF, IP10 , MCP1, MIP1A and TNFα, followed by edema, gas exchange dysfunction, acute respiratory distress syndrome, cardiac injury and secondary infection that can lead to death. Therefore, avoiding a "cytokine storm" may be the key to treating patients infected with Sars-Cov-2. Mesenchymal stem cells (MSCs), due to their potential for immunomodulatory activity, can have beneficial effects in preventing or attenuating the cytokine storm. Because MSCs have been widely used in cell therapy, from basic research to clinical trials. Safety and efficacy have been clearly documented in several clinical trials, especially in immune-mediated inflammatory diseases, such as graft versus host disease (GVHD). The objective of the study is to verify the safety and feasibility of using allogeneic bone marrow mesenchymal stem cells in patients with SARS-CoV-2.

Conditions

COVID-19; Sars-CoV2

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intervention

Intravenous 1\*10E6 MSCs/kg body weight Mesenchymal Stromal Cells infusion

Group Type: EXPERIMENTAL

Mesenchymal Stromal Cells infusion

Intervention Type: BIOLOGICAL

Intravenous 1\*10E6 MSCs/kg body weight Mesenchymal Stromal Cells infusion

Interventions

Mesenchymal Stromal Cells infusion

Intravenous 1\*10E6 MSCs/kg body weight Mesenchymal Stromal Cells infusion

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• Laboratory confirmation of COVID19 infection by reverse-transcription polymerase chain reaction (RT-PCR)
• The patient or legal donor agrees to participate in the study and signs the informed consent.
• Patients with orange or red criteria according to the score proposed by Liao et al (2020)

Exclusion Criteria

• Patient with pregnancy, are planning to become pregnant or breastfeeding
• Patients with malignant blood-borne diseases such as HIV or syphilis
• Not consenting for clinical trial
• Patients with other than orange or red criteria according to the score proposed by Liao et al (2020)

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital de Clinicas de Porto Alegre

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lucia Silla, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Hospital de Clinicas de Porto Alegre

Central Contacts

Lucia Silla, MD, PhD

Role: CONTACT

lsilla@hcpa.edu.br

55 51 33598371

Annelise Pezzi, PhD

Role: CONTACT

annepezzi@gmail.com

Other Identifiers

20200148

Identifier Type: -

Identifier Source: org_study_id