Mesenchymal Stem Cells Therapy in Patients With COVID-19 Pneumonia

NCT ID: NCT04713878

Last Updated: 2021-01-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-05-08
• Study Completion Date: 2020-07-15

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

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:

1. group: Intubated without comorbidity (n:7)

2. group: Intubated with comorbidity (n:7)

3. group: No intubated (n:7)

Dosage of Mesenchymal stem cells:

1. 1 million cell/kg iv--------------------------------------------------day 0

2. 1 million cell/kg iv -------------------------------------------------day 2

3. 1 million cell/kg iv -------------------------------------------------day 4

Conditions

Coronavirus Disease 2019 (COVID-19) Pneumonia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group 1

Intubated without comorbidity

Group Type: ACTIVE_COMPARATOR

Mesenchymal stem cells

Intervention Type: OTHER

Intravenous infusion of Mesenchymal stem cells

Group 2

Intubated with comorbidity

Group Type: ACTIVE_COMPARATOR

Mesenchymal stem cells

Intervention Type: OTHER

Intravenous infusion of Mesenchymal stem cells

Group 3

No intubated

Group Type: ACTIVE_COMPARATOR

Mesenchymal stem cells

Intervention Type: OTHER

Intravenous infusion of Mesenchymal stem cells

Interventions

Mesenchymal stem cells

Intravenous infusion of Mesenchymal stem cells

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kanuni Sultan Suleyman Training and Research Hospital

OTHER

Sponsor Role: lead

Responsible Party

Ayca Sultan Sahin

Assoc Prof

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ebru Kaya, MD

Role: STUDY_CHAIR

Kanuni Sultan Suleyman Education and Training Hospital

Gursel Turgut, Prof Dr

Role: STUDY_CHAIR

Genkord

Ali Kocatas, MD

Role: STUDY_CHAIR

Kanuni Sultan Suleyman Education and Training Hospital

Locations

University of Health Sciences

Istanbul, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

2020.05.20

Identifier Type: -

Identifier Source: org_study_id