Mesenchymal Stem Cells Therapy in Patients With COVID-19 Pneumonia
Primary Purpose
Coronavirus Disease 2019 (COVID-19) Pneumonia
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Mesenchymal stem cells
Sponsored by
About this trial
This is an interventional treatment trial for Coronavirus Disease 2019 (COVID-19) Pneumonia focused on measuring Mesenchymal stem cells, COVID-19, Pneumonia
Eligibility Criteria
Inclusion Criteria:
- aged 18-90 male or female
- laboratory approve of RT-PCR (real-time reverse transcription polymerase chain reaction) with COVID-19 infection
- pneumonia assessed by chest radiography or computed tomography
- In accordance with any of the following: 1)Respiratory rate ≥ 30 times / min 2) oxygen saturation ≤ 93% 3) arterial pressure of oxygen/the fraction of inspired oxygen≤ 300mmHg, 4) pulmonary imaging of focus within 24-48 hours > 50% progression
- patients who remain unresponsive to medications administered according to Ministry of health guidelines
- Patients who receiving invasive or non-invasive mechanical ventilation therapy in intensive care
Exclusion Criteria:
- Pregnancy
- Any kind of cancer, severe liver disease
- Failure to provide informed consent or comply with test requirements
- Known allergy or hypersensitivity to MSCs
Sites / Locations
- University of Health Sciences
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
Group 1
Group 2
Group 3
Arm Description
Intubated without comorbidity
Intubated with comorbidity
No intubated
Outcomes
Primary Outcome Measures
Change of clinical symptoms as respiratory distress or need for oxygen support
Recovery of patient from mechanical and oxygen support
Change of cytokine storm parameters
respiratory rates < 30 times /min
Change of pulmonary functions
Oxygen saturation > 93% and pulmonary imaging of focus within 24-48 hours > 50% progression
Change of clinical symptoms
arterial pressure of oxygen/the fraction of inspired oxygen>300mmHg
Secondary Outcome Measures
Full Information
NCT ID
NCT04713878
First Posted
January 9, 2021
Last Updated
January 16, 2021
Sponsor
Kanuni Sultan Suleyman Training and Research Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04713878
Brief Title
Mesenchymal Stem Cells Therapy in Patients With COVID-19 Pneumonia
Official Title
A 8-Week Trial of Mesenchymal Stem Cells Therapy in Patients With COVID-19 Pneumonia
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
May 8, 2020 (Actual)
Primary Completion Date
June 30, 2020 (Actual)
Study Completion Date
July 15, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kanuni Sultan Suleyman Training and Research Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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:
Providing immune modulation by Stem Cell Transplantation and reducing the damage caused by cytokine storm to tissues and organs,
Correcting immunosuppression and fight against COVID-19 virus by editing B and T cells,
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 (No:2020.05.20). 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 patient's 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:
group: Intubated without comorbidity (n:7)
group: Intubated with comorbidity (n:7)
group: No intubated (n:7)
Dosage of Mesenchymal stem cells:
1 million cell/kg iv--------------------------------------------------day 0
1 million cell/kg iv -------------------------------------------------day 2
1 million cell/kg iv -------------------------------------------------day 4
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronavirus Disease 2019 (COVID-19) Pneumonia
Keywords
Mesenchymal stem cells, COVID-19, Pneumonia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Coronavirus Disease 2019 (COVID-19) patients with pneumonia
1.group: Intubated without comorbidity, 2.group: Intubated with comorbidity, 3.group: No intubated
Masking
None (Open Label)
Allocation
Randomized
Enrollment
21 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group 1
Arm Type
Active Comparator
Arm Description
Intubated without comorbidity
Arm Title
Group 2
Arm Type
Active Comparator
Arm Description
Intubated with comorbidity
Arm Title
Group 3
Arm Type
Active Comparator
Arm Description
No intubated
Intervention Type
Other
Intervention Name(s)
Mesenchymal stem cells
Intervention Description
Intravenous infusion of Mesenchymal stem cells
Primary Outcome Measure Information:
Title
Change of clinical symptoms as respiratory distress or need for oxygen support
Description
Recovery of patient from mechanical and oxygen support
Time Frame
3 months
Title
Change of cytokine storm parameters
Description
respiratory rates < 30 times /min
Time Frame
3 months
Title
Change of pulmonary functions
Description
Oxygen saturation > 93% and pulmonary imaging of focus within 24-48 hours > 50% progression
Time Frame
3 months
Title
Change of clinical symptoms
Description
arterial pressure of oxygen/the fraction of inspired oxygen>300mmHg
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
aged 18-90 male or female
laboratory approve of RT-PCR (real-time reverse transcription polymerase chain reaction) with COVID-19 infection
pneumonia assessed by chest radiography or computed tomography
In accordance with any of the following: 1)Respiratory rate ≥ 30 times / min 2) oxygen saturation ≤ 93% 3) arterial pressure of oxygen/the fraction of inspired oxygen≤ 300mmHg, 4) pulmonary imaging of focus within 24-48 hours > 50% progression
patients who remain unresponsive to medications administered according to Ministry of health guidelines
Patients who receiving invasive or non-invasive mechanical ventilation therapy in intensive care
Exclusion Criteria:
Pregnancy
Any kind of cancer, severe liver disease
Failure to provide informed consent or comply with test requirements
Known allergy or hypersensitivity to MSCs
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ebru Kaya, MD
Organizational Affiliation
Kanuni Sultan Suleyman Education and Training Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Gursel Turgut, Prof Dr
Organizational Affiliation
Genkord
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Ali Kocatas, MD
Organizational Affiliation
Kanuni Sultan Suleyman Education and Training Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
University of Health Sciences
City
Istanbul
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Mesenchymal Stem Cells Therapy in Patients With COVID-19 Pneumonia
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