NCT04392778

Clinical Use of Stem Cells for the Treatment of Covid-19

What is the Effect of Mesenchymal Stem Cell Therapy on Seriously Ill Patients With Covid 19 in Intensive Care? (Prospective Double Controlled Study)

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: SBÜ Dr. Sadi Konuk Eğitim ve Araştırma Hastanesi · Academic / Other
• Sex: All
• Age: 40 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

This study aims to use the regenerative and repair abilities of stem cells to fight against the harmful effects of the novel coronavirus Covid-19 and therefore develop a treatment strategy. It is known that fatalities from this virus is largely caused by its damage to lungs and other organs. As the disease progresses, these organs fail and lead to mortality. Our hope is that the stem cell transplantation from healthy donors will repair the damage caused by the virus and result in a healthy recovery.

Detailed description

Introduction: The COVID-19 corona virus epidemic has spread from Wuhan, China to the whole world, and has been declared a pandemic by WHO worldwide. In severe patients, ARDS and multiple organ failure can be seen. This condition is associated with cytokine storm in the body. When the virus invades the body, dentric cells can activate macrophages, lymphocytes and natural killer cells. Mesenchymal stem cells (MKH) not only inhibit the abnormal activation of T lymphocytes and macrophages, but also encourage them to differentiate into regulatory T cell subsets (Treg) clusters and anti-inflammatory macrophages. MSCs application proved therapeutic efficiency during influenza infection resulting in reduced impairment of alveolar fluid clearance and lung injury. This was attributed towards attenuation of pro-inflammatory cytokine secretion, inflammatory cell recruitment and increased alveolar macrophages content. Aim of study: 1. To provide immune modulation to patients with COVID-19 who are taken to intensive care and resistant to treatment by performing MSCs transplantation and to reduce the damage caused by cytokin storm to tissues and organs, 2. Correcting immunosuppression in patients and increasing the fight against COVID-19 virus by CD4+T, CD+8T cellular cell arrangement, 3. It is to accelerate the recovery in organ damage by increasing growth factors by means of MSCs. Materials and method: Patients diagnosed with COVID-19 infection as clinically, radiologically and laboratory-wise will be divided into three groups: Group 1: patients that are not on a ventilator (n=10) Group 2: patients that are on a ventilator and will receive saline injections (n=10) Group 3: patients that are on a ventilator and will receive MSC transplantation injections (n=10) Mesenchymal stem cells originating from allogenic umbilical cord produced under GMP conditions will be administered in 3 times, with doses indicated below, intravenously within 1 week. Dose: 1. Application: 3 million cells / kg IV ---------------------------------------- --------- 1 day 2. Application: 3 million cells / kg IV ---------------------------------------- --------- 3. Day 3. Application: 3 million cells / kg IV ---------------------------------------- --------- 6. Day The blood will be analyzed for the expression levels of growth factors, including vascular endothelial growth factor, fibroblast growth factor, platelet derived-growth factor, epidermal growth factor, transforming growth factor beta, hepatocyte growth factor, nerve growth factor, VEGF receptor (VEGFR), angiopoietin1 (Angpt-1), and Angpt-2, using sandwich enzyme-linked immune sorbent assays (ELISAs). Investigators also analyzed the caspase-3 system in the blood. immunoassay kits will be used for analyses in accordance with the manufacturer's instructions. Biochemical parameters of the liver, such as alanine transaminase (ALT), aspartate transaminase (AST), total protein, albumin, total bilirubin, direct bilirubin, and alkaline phosphatase (ALP) levels, will be measured in the venous blood samples. Proinflammatory (IL1-β, IL-6, TNFα, INF-γ) and anti-inflammatory (IL-2, IL-4, IL-10, IL-13) cytokines will be examined in venous blood in order to determine the immune modulatory effect of stem cells. CD4 + T, CD4 + T killer cells Granulocyte macrophage colony factor BLC-2 VEGF-R angiopoetin-1, angiopoetin-2 Total antioxidant capacity (TAC) Total oxidant capacity (TOC).

Conditions

• Covid19
• Pneumonia
• Multiple Organ Failure
• Corona Virus Infection

Interventions

Type	Name	Description
BIOLOGICAL	MSC Treatment	Protocol length: 1 week Doses: 1. Application: 3 million cells/kg IV-------------------------------------------------0 day 2. Application: 3 million cells/kg IV ------------------------------------------------3rd day 3. Application: 3 million cells/kg IV -------------------------------------------------6th day will be given to patients positively, clinically and radiologically diagnosed with COVID-19, followed with 3 months observation.
BIOLOGICAL	Saline Control	Saline will be given to patients positively, clinically and radiologically diagnosed with COVID-19, followed with 3 months observation.

Timeline

• Start date: 2020-04-01
• Primary completion: 2020-11-01
• Completion: 2020-11-30
• First posted: 2020-05-19
• Last updated: 2021-05-25

Locations

2 sites across 1 country: Turkey (Türkiye)