Mesenchymal Stem Cells Therapy in Patients With COVID-19 Pneumonia

January 16, 2021 updated by: Ayca Sultan Sahin, Kanuni Sultan Suleyman Training and Research Hospital

A 8-Week Trial of Mesenchymal Stem Cells Therapy in Patients With COVID-19 Pneumonia

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

21

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Istanbul, Turkey
        • University of Health Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group 1
Intubated without comorbidity
Other: Mesenchymal stem cells
Intravenous infusion of Mesenchymal stem cells
Active Comparator: Group 2
Intubated with comorbidity
Other: Mesenchymal stem cells
Intravenous infusion of Mesenchymal stem cells
Active Comparator: Group 3
No intubated
Other: Mesenchymal stem cells
Intravenous infusion of Mesenchymal stem cells

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kanuni Sultan Suleyman Training and Research Hospital

Investigators

  • Study Chair: Ebru Kaya, MD, Kanuni Sultan Suleyman Education and Training Hospital
  • Study Chair: Gursel Turgut, Prof Dr, Genkord
  • Study Chair: Ali Kocatas, MD, Kanuni Sultan Suleyman Education and Training Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 8, 2020

Primary Completion (Actual)

June 30, 2020

Study Completion (Actual)

July 15, 2020

Study Registration Dates

First Submitted

January 9, 2021

First Submitted That Met QC Criteria

January 15, 2021

First Posted (Actual)

January 19, 2021

Study Record Updates

Last Update Posted (Actual)

January 20, 2021

Last Update Submitted That Met QC Criteria

January 16, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020.05.20

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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