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Mesenchymal Stem Cells Therapy in Patients With COVID-19 Pneumonia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04713878
Recruitment Status : Completed
First Posted : January 19, 2021
Last Update Posted : January 20, 2021
Sponsor:
Information provided by (Responsible Party):
Ayca Sultan Sahin, 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


Condition or disease Intervention/treatment Phase
Coronavirus Disease 2019 (COVID-19) Pneumonia Other: Mesenchymal stem cells Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Primary Purpose: Treatment
Official Title: A 8-Week Trial of Mesenchymal Stem Cells Therapy in Patients With COVID-19 Pneumonia
Actual Study Start Date : May 8, 2020
Actual Primary Completion Date : June 30, 2020
Actual Study Completion Date : July 15, 2020

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Change of clinical symptoms as respiratory distress or need for oxygen support [ Time Frame: 3 months ]
    Recovery of patient from mechanical and oxygen support

  2. Change of cytokine storm parameters [ Time Frame: 3 months ]
    respiratory rates < 30 times /min

  3. Change of pulmonary functions [ Time Frame: 3 months ]
    Oxygen saturation > 93% and pulmonary imaging of focus within 24-48 hours > 50% progression

  4. Change of clinical symptoms [ Time Frame: 3 months ]
    arterial pressure of oxygen/the fraction of inspired oxygen>300mmHg



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04713878


Locations
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Turkey
University of Health Sciences
Istanbul, Turkey
Sponsors and Collaborators
Kanuni Sultan Suleyman Training and Research Hospital
Investigators
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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 Documents (Full-Text)

Documents provided by Ayca Sultan Sahin, Kanuni Sultan Suleyman Training and Research Hospital:
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Responsible Party: Ayca Sultan Sahin, Assoc Prof, Kanuni Sultan Suleyman Training and Research Hospital
ClinicalTrials.gov Identifier: NCT04713878    
Other Study ID Numbers: 2020.05.20
First Posted: January 19, 2021    Key Record Dates
Last Update Posted: January 20, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ayca Sultan Sahin, Kanuni Sultan Suleyman Training and Research Hospital:
Mesenchymal stem cells
COVID-19
Pneumonia
Additional relevant MeSH terms:
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COVID-19
Pneumonia
Respiratory Tract Infections
Infections
Pneumonia, Viral
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases