Mesenchymal Stem Cells Therapy in Patients With COVID-19 Pneumonia

Not Applicable

Completed

• Conditions: Coronavirus Disease 2019 (COVID-19) Pneumonia
• Interventions: Other: Mesenchymal stem cells

• Registration Number: NCT04713878
• Lead Sponsor: Kanuni Sultan Suleyman Training and Research Hospital

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

Study Timeline

• Study Start: 2020-05-08
• Primary Completion: 2020-06-30
• Study Completion: 2020-07-15
• Status Verified: 2021-01
• Study First Submitted: 2021-01-09
• Study First Submitted QC: 2021-01-15
• Last Update Submitted: 2021-01-16
• Study First Posted: 2021-01-19
• Last Update Posted: 2021-01-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 2	Mesenchymal stem cells	Intubated with comorbidity
Group 1	Mesenchymal stem cells	Intubated without comorbidity
Group 3	Mesenchymal stem cells	No intubated

Primary Outcome Measures

Name	Time	Method
Change of clinical symptoms as respiratory distress or need for oxygen support	3 months	Recovery of patient from mechanical and oxygen support
Change of cytokine storm parameters	3 months	respiratory rates \< 30 times /min
Change of pulmonary functions	3 months	Oxygen saturation \> 93% and pulmonary imaging of focus within 24-48 hours \> 50% progression
Change of clinical symptoms	3 months	arterial pressure of oxygen/the fraction of inspired oxygen\>300mmHg

Trial Locations

Locations (1)

University of Health Sciences; 🇹🇷 Istanbul, Turkey