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Clinical Use of Stem Cells for the Treatment of Covid-19

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04392778
Recruitment Status : Recruiting
First Posted : May 19, 2020
Last Update Posted : May 19, 2020
Sponsor:
Collaborators:
Istinye University
Regenerative Medicine and Stem Cell Production Center Liv MedCell
Liv Hospital (Ulus)
Information provided by (Responsible Party):
SBÜ Dr. Sadi Konuk Eğitim ve Araştırma Hastanesi

Brief Summary:
This study aims to use the regenerative and repair abilities of stem cells to fight against the harmful effects of the novel coronavirus Covid-19 and therefore develop a treatment strategy. It is known that fatalities from this virus is largely caused by its damage to lungs and other organs. As the disease progresses, these organs fail and lead to mortality. Our hope is that the stem cell transplantation from healthy donors will repair the damage caused by the virus and result in a healthy recovery.

Condition or disease Intervention/treatment Phase
Covid19 Pneumonia Multiple Organ Failure Corona Virus Infection Biological: MSC Treatment Biological: Saline Control Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: What is the Effect of Mesenchymal Stem Cell Therapy on Seriously Ill Patients With Covid 19 in Intensive Care? (Prospective Double Controlled Study)
Actual Study Start Date : April 1, 2020
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : September 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Untreated
Group 1: patients that are not on a ventilator (n=10) No extra intervention will be done.
Sham Comparator: Saline Control
Group 2: patients that are on a ventilator and will receive saline injections (n=10) as control for MSC transplantation group (3).
Biological: Saline Control
Saline will be given to patients positively, clinically and radiologically diagnosed with COVID-19, followed with 3 months observation.

Experimental: Experimental UC-MSCs
Group 3: patients that are on a ventilator and will receive MSC transplantation injections (n=10)
Biological: MSC Treatment

Protocol length: 1 week

Doses:

  1. Application: 3 million cells/kg IV-------------------------------------------------0 day
  2. Application: 3 million cells/kg IV ------------------------------------------------3rd day
  3. Application: 3 million cells/kg IV -------------------------------------------------6th day

will be given to patients positively, clinically and radiologically diagnosed with COVID-19, followed with 3 months observation.





Primary Outcome Measures :
  1. Clinical improvement [ Time Frame: 3 months ]
    Improvement of clinical symptoms related to Covid-19 infection (fever, pneumonia, shortness of breath)


Secondary Outcome Measures :
  1. Lung damage improvement [ Time Frame: 3 months ]
    Improvement of lungs assessed by CT Scan

  2. Sars-Cov-2 viral infection laboratory test [ Time Frame: 3 months ]
    Negative, measured by RT-PCR laboratory tests for the virus

  3. Blood test [ Time Frame: 3 months ]
    Cell types and numbers



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   40 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 40-60 years old male or female
  • Confirmed 2019-nCoV infection with RT-PCR Laboratory test
  • Confirmed Pneumonia with chest radiography and computer tomography
  • and any of the following criteria:

    1. Shortness of breath (RR ≥30/min)
    2. Resting finger oxygen saturation 93%
    3. Arterial oxygen partial pressure (PaO2)/oxygen absorption concentration (FiO2) ≤ 300MMHG
    4. Advancing of focus in Pulmonary imaging to >50% in 24-48 hours

Exclusion Criteria:

  • Those who are not pregnant, breastfeeding and pregnant but who do not take effective contraceptive measures;
  • Patients with malignant tumors, other serious systemic diseases and psychosis;
  • Informed consent is not given or does not comply with the test requirements.
  • Co-infection of HIV, tuberculosis, influenza virus, adenovirus and other respiratory infection virus.
  • Pneumonia caused by bacteria, mycoplasma, chlamydia, legionella, fungi or co-infection of HIV, tuberculosis, influenza virus, adenovirus and other respiratory infection virus.
  • Obstructive HABP / VABP caused by lung cancer or other known causes; Long-term history of use of immunosuppressive agents;
  • History of epilepsy and need for continuous anticonvulsant therapy or anticonvulsant therapy taken within 3 years;
  • Invasive ventilation
  • Shock
  • Other organ failures

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): NCT04392778


Contacts
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Contact: Gokhan T Adas, Prof.Dr. 05326155892 gokhantolgaadas@gmail.com
Contact: Erdal Karaoz, Prof.Dr. 05327423472 ekaraoz@hotmail.com

Locations
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Turkey
Istinye University Recruiting
Istanbul, Turkey, 34010
Contact: Erdal Karaoz, Prof.Dr.    05327423472    ekaraoz@hotmail.com   
SBÜ Dr. Sadi Konuk Eğitim ve Araştırma Hastanesi Recruiting
Istanbul, Turkey, 34147
Contact: Gokhan T Adas, Prof.Dr.    05326155892    gokhantolgaadas@gmail.com   
Sponsors and Collaborators
SBÜ Dr. Sadi Konuk Eğitim ve Araştırma Hastanesi
Istinye University
Regenerative Medicine and Stem Cell Production Center Liv MedCell
Liv Hospital (Ulus)
Investigators
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Principal Investigator: Gokhan T Adas, Prof.Dr. SBÜ Dr. Sadi Konuk Eğitim ve Araştırma Hastanesi
Principal Investigator: Erdal Karaoz, Prof.Dr. Istinye University
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Responsible Party: SBÜ Dr. Sadi Konuk Eğitim ve Araştırma Hastanesi
ClinicalTrials.gov Identifier: NCT04392778    
Other Study ID Numbers: Bak. Sadi Konuk-Istinye Uni.
First Posted: May 19, 2020    Key Record Dates
Last Update Posted: May 19, 2020
Last Verified: May 2020
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 SBÜ Dr. Sadi Konuk Eğitim ve Araştırma Hastanesi:
Covid-19
Pneumonia
Multiple Organ Failure
Coronavirus
Mesenchymal stem cells
Cellular therapy
Additional relevant MeSH terms:
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Coronavirus Infections
Severe Acute Respiratory Syndrome
Pneumonia
Multiple Organ Failure
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Virus Diseases
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Shock
Pathologic Processes