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

COVID-19 Clinical Trial

— COVID19  

Official title:

Safety and Feasibility of Allogenic Mesenchymal Stromal Cells in the Treatment of COVID-19

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04467047
• Other study ID #: 20200148
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: July 25, 2020
• Est. completion date: December 30, 2020

Study information

• Verified date: July 2020
• Source: Hospital de Clinicas de Porto Alegre
• Contact: Lucia Silla, MD, PhD
• Phone: 55 51 33598371
• Email: lsilla[@]hcpa.edu.br
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 10
• Est. completion date: December 30, 2020
• Est. primary completion date: October 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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)

Related Conditions & MeSH terms

• COVID-19
• Sars-CoV2

Intervention

Biological:
• Mesenchymal Stromal Cells infusion
Intravenous 1*10E6 MSCs/kg body weight Mesenchymal Stromal Cells infusion

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hospital de Clinicas de Porto Alegre

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival	Assessment of Overall survival at 30 days post intervention	60 days
Secondary	Changes on inflammatory C-reactive protein	To assess the anti-inflammatory effect of the proposed treatment with assessment of the levels of C-reactive protein (mg/dL)	60 days
Secondary	Hospital stay	days of the patients in hospital	60 days
Secondary	Oxygenation index (PaO2/FiO2)	Evaluation of functional respiratory changes: PaO2 / FiO2 ratio	60 days
Secondary	Improvement in Liao's score (2020)	Improvement in Liao's score (2020)	60 days
Secondary	Radiological improvement	Computed tomography Chest assesment will be done to assess improvement in radiological findings of COVID-19	60 days
Secondary	Time of COVID19 PCR negativity	PCR testing to check PCR negativity	28 days