Ignite Creation Date:
2024-05-06 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 1:54 PM
Study NCT ID:
NCT04713878
Status:
COMPLETED
Last Update Posted:
2021-01-20
First Post:
2021-01-09
Brief Title:
Mesenchymal Stem Cells Therapy in Patients With COVID-19 Pneumonia
Sponsor:
Kanuni Sultan Suleyman Training and Research Hospital
Organization:
Kanuni Sultan Suleyman Training and Research Hospital
Study Overview
Official Title:
A 8-Week Trial of Mesenchymal Stem Cells Therapy in Patients With COVID-19 Pneumonia
Status:
COMPLETED
Status Verified Date:
2021-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Due to the cytokine storm that develops as a result of Coronavirus Disease 2019 COVID-19 infection some patients hospitalization to intensive care cause of pneumonia Acute Respiratory Distress Syndrome ARDS and multiple organ failure Mortality is higher in treatment-resistant cases
Purpose of this study
1 Providing immune modulation by Stem Cell Transplantation and reducing the damage caused by cytokine storm to tissues and organs
2 Correcting immunosuppression and fight against COVID-19 virus by editing B and T cells
3 It is to accelerate healing in organ damage by increasing growth factors through mesenchymal stem cells
Primary outcome Improvement of clinical symptoms reduction of cytokine storm Secondary outcome Recovery of patients from mechanical ventilation
Purpose of this study
1 Providing immune modulation by Stem Cell Transplantation and reducing the damage caused by cytokine storm to tissues and organs
2 Correcting immunosuppression and fight against COVID-19 virus by editing B and T cells
3 It is to accelerate healing in organ damage by increasing growth factors through mesenchymal stem cells
Primary outcome Improvement of clinical symptoms reduction of cytokine storm Secondary outcome Recovery of patients from mechanical ventilation
Detailed Description:
Study design and participants This study was a single-center open-label randomized trial conducted at an Education and Training Hospital Istanbul from May to July 2020 and it was performed according to the Declaration of Helsinki and approved by the Ethics Committee and health ministry No20200520 Written informed consent was obtained from all patients or their representatives when data were collected prospectively
Age gender mortality status APACHE II score number of days in ICU procalcitonin and C-reactive protein values leukocyte values comorbid diseases The cluster of differentiations 4 and 8 CD4 and CD8 interleukin -2 interleukin -6 Tumor necrosis factor-alpha-beta levels will be recorded
Clinical results changes in inflammatory and immune function levels and side effects will be recorded The patients lung function and symptoms will be recorded after Mesenchymal Stem Cell transplantation After treatment lymphocyte C-reactive protein Tumor Necrosis alpha-beta levels interleukin-6 levels will be recorded
Patients were divided into 3 groups
1 group Intubated without comorbidity n7
2 group Intubated with comorbidity n7
3 group No intubated n7
Dosage of Mesenchymal stem cells
1 1 million cellkg iv--------------------------------------------------day 0
2 1 million cellkg iv -------------------------------------------------day 2
3 1 million cellkg iv -------------------------------------------------day 4
Age gender mortality status APACHE II score number of days in ICU procalcitonin and C-reactive protein values leukocyte values comorbid diseases The cluster of differentiations 4 and 8 CD4 and CD8 interleukin -2 interleukin -6 Tumor necrosis factor-alpha-beta levels will be recorded
Clinical results changes in inflammatory and immune function levels and side effects will be recorded The patients lung function and symptoms will be recorded after Mesenchymal Stem Cell transplantation After treatment lymphocyte C-reactive protein Tumor Necrosis alpha-beta levels interleukin-6 levels will be recorded
Patients were divided into 3 groups
1 group Intubated without comorbidity n7
2 group Intubated with comorbidity n7
3 group No intubated n7
Dosage of Mesenchymal stem cells
1 1 million cellkg iv--------------------------------------------------day 0
2 1 million cellkg iv -------------------------------------------------day 2
3 1 million cellkg iv -------------------------------------------------day 4
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None