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Mesenchymal Stem Cell for Acute Respiratory Distress Syndrome Due for COVID-19 (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: NCT04416139
Recruitment Status : Recruiting
First Posted : June 4, 2020
Last Update Posted : June 4, 2020
Sponsor:
Information provided by (Responsible Party):
Martín Iglesias, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Brief Summary:

Acute Respiratory Distress Syndrome (ARDS) is the main cause of death from COVID-19. One of the main mechanisms for ARDS is the violent storm of cytokines and chemokines, which cause uncontrolled fatal systemic inflammation by the immune system on the body, with additional multiple organ failure. Mortality in cases of severe ARDS caused by COVID 19 varies significantly between 50 and 90%, basically depending on the age of the patient and the presence of comorbidities.

The plasticity of Mesenchymal Stem Cells (MSC) regulates inflammation and immunity. MSC can promote and inhibit an immune response, depending on the dynamics of inflammation and depending on the activation force of the immune system, the types of inflammatory cytokines present, and the effects of immunosuppressants. Essentially, the state of inflammation determines the immunoregulatory fate of MSC. Thus, IV application of AMSCa has been shown to control the inflammatory response in various diseases, such as the graft-versus-host reaction and the ARDS caused by H5NI.

The objective of this study is to describe the clinical changes secondary to IV administration of MSC allogenic, in patients with bilateral COVID-19 pneumonia complicated by severe ARDS, with the evaluation of the PaO2 / FiO2 ratio, heart and respiratory rates, and the fever curve.

Five patients, of either sex, over 18 years of age, with bilateral pneumonia caused by COVID-19 and severe SIRA that has not improved with the standard management measures used at that time in the care center, will be included in the study. This treatment will be administered after discussing it with the relatives that it is a procedure considered as rescue and will be carried out with informed consent. 1x10(6) xKg will be applied IV.

The follow-up of the patient will be for three weeks. PaO2 / FiO2 data, fever, inflammatory markers and immunity will be evaluated. The results will be compared with the historical controls attended at INCMNSZ.


Condition or disease Intervention/treatment Phase
Covid 19 Biological: Infusion IV of Mesenchymal Stem cells Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Mesenchymal Stem Cell from umbilical cord allogenic from de bank laboratory, will be applied IV to 5 patients con pneumonia bilateral due to COVID 19, complicated with acute respiratory distress syndrome. The clinical, biochemical, inflammatory and immune changes will be described and compare against historical cases treated in the Instituto Nacional de Ciencias Medicas y Nutrición Salvador Zubirán
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Mesenchymal Stem Cells for the Treatment of Severe Acute Respiratory Distress Syndrome Due to COVID-19. Pilot Study
Actual Study Start Date : May 1, 2020
Estimated Primary Completion Date : April 30, 2021
Estimated Study Completion Date : May 1, 2021


Arm Intervention/treatment
Active Comparator: Treated group
Five patients, of any sex and age, with bilateral COVID-19 pneumonia, severe SIRA with PaO2 / FiO2 less than 150, lymphopenia less than 800 total lymphocytes, CT with bilateral pneumonia, SOFA less than 11 and that has not improved in relation to the following parameters: a) persistent PaO2 / FiO2 less than 150; b) persistent fever, c) increase in D-dimer of at least 50% of the baseline and / or ferritin greater than 1000, after 48 h of hospital stay receiving the standard management measures used at that time in the Care Center, will be included in the study. This treatment will be administered after discussing it with the relatives that it is a procedure considered as rescue and will be carried out with informed consent.
Biological: Infusion IV of Mesenchymal Stem cells
Mesenchymal Stem cells from bank will be applied IV, at dose 1 million xKg in a single dose

No Intervention: Control Group
The results obtained in the treated group will be compared against the historical controls treated in INCMNSZ, evaluating the same variables.



Primary Outcome Measures :
  1. Functional Respiratory changes: PaO2 / FiO2 ratio [ Time Frame: Three weeks ]
    To describe the clinical changes secondary to IV administration of AMSCa, in patients with bilateral COVID-19 pneumonia complicated by severe SIRA, with the evaluation of the PaO2 / FiO2 ratio.

  2. Clinical cardiac changes: Heart rate per minute [ Time Frame: Three weeks ]
    To describe the clinical changes secondary to IV administration of AMSCa, in patients with bilateral COVID-19 pneumonia complicated by severe SIRA, with the evaluation of the heart rate per minute.

  3. Clinical Respiratory Changes: Respiratory rate per minute [ Time Frame: Three weeks ]
    To describe the clinical changes secondary to IV administration of AMSCa, in patients with bilateral COVID-19 pneumonia complicated by severe SIRA, with the evaluation of the respiratory rate per minute.

  4. Changes in body temperature [ Time Frame: Three weeks ]
    To describe the clinical changes secondary to IV administration of AMSCa, in patients with bilateral COVID-19 pneumonia complicated by severe SIRA, with the evaluation of the fever curve in degrees centigrade.


Secondary Outcome Measures :
  1. General biochemical changes in Leukocytes [ Time Frame: Three weeks ]
    To assess the effect of the proposed treatment on the total Leukocytes

  2. General biochemical changes on lymphocytes [ Time Frame: Three weeks ]
    To assess the effect of the proposed treatment on absolute lymphocytes

  3. General biochemical changes on platelets [ Time Frame: Three weeks ]
    To assess the effect of the proposed treatment on total platelets

  4. General biochemical changes on fibrinogen [ Time Frame: Three weeks ]
    To assess the effect of the proposed treatment on serum fibrinogen

  5. General biochemical changes on pocalcitonin [ Time Frame: Three weeks ]
    To assess the effect of the proposed treatment on procalcitonin

  6. General biochemical changes on ferritin [ Time Frame: Three weeks ]
    To assess the effect of the proposed treatment on ferritin

  7. General biochemical changes on D-dimer [ Time Frame: Three weeks ]
    To assess the effect of the proposed treatment on D-dimer

  8. Changes on inflammatory C-reactive protein [ Time Frame: Three weeks ]
    To assess the anti-inflammatory effect of the proposed treatment with assessment of the levels of C-reactive protein

  9. Cahnges on Inflammatory cytokine TNFa [ Time Frame: Three weeks ]
    To assess the anti-inflammatory effect of the proposed treatment with assessment of the levels of TNFa in plasma.

  10. Changes on Inflammatory cytokine IL10 [ Time Frame: Three weeks ]
    To assess the anti-inflammatory effect of the proposed treatment with assessment of the levels of IL10 in plasma.

  11. Changes on Inflammatory cytokine IL1 [ Time Frame: Three weeks ]
    To assess the anti-inflammatory effect of the proposed treatment with assessment of the levels of IL1 in plasma.

  12. Changes on Inflammatory cytokine IL6 [ Time Frame: Three weeks ]
    To assess the anti-inflammatory effect of the proposed treatment with assessment of the levels of IL6 in plasma.

  13. Changes on Inflammatory cytokine IL 17 [ Time Frame: Three weeks ]
    To assess the anti-inflammatory effect of the proposed treatment with assessment of the levels of IL17 in plasma

  14. Changes on VEGF [ Time Frame: Three weeks ]
    To assess the anti-inflammatory effect of the proposed treatment with assessment of the levels of VEGF in plasma

  15. Radiological Changes [ Time Frame: Three weeks ]
    Assess the radiological evolution of the proposed treatment through simple chest CT

  16. Immunological changes on T cell [ Time Frame: Three weeks ]
    Evaluate immune system improvement with mass cytometry to analyze patients' immune cells: regulatory T cells

  17. Immunological changes on Dendritic cells [ Time Frame: Three weeks ]
    Evaluate immune system improvement with mass cytometry to analyze patients' immune cells: dendritic cells

  18. Immunological changes on CD4+ T [ Time Frame: Three weeks ]
    Evaluate immune system improvement with mass cytometry to analyze patients' immune cells: CD4 + T

  19. Immunological changes on CD8+ T [ Time Frame: Three weeks ]
    Evaluate immune system improvement with mass cytometry to analyze patients' immune cells: CD8 + T

  20. Immunological changes on NK cell [ Time Frame: Three weeks ]
    Evaluate immune system improvement with mass cytometry to analyze patients' immune cells: NK cells

  21. Adverse events [ Time Frame: Three weeks ]
    Evaluate the safety of the proposed treatment (allergic reactions and / or infection)

  22. RNA detection by SARS-Cov2 PCR [ Time Frame: Three weeks ]
    To assess the negativization of the SARS-Cov2 PCR RNA detection test



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Bilateral pneumonia due to COVID-19
  • With SARS-Cov2 PCR RNA detection test, positive
  • Severe ARDS
  • PaO2/FiO2 <150
  • Leukocytes < 800
  • Chest TAC with pneumonia bilateral
  • persistant fever
  • increase 50% D-Dimer, respect to basal value
  • Ferritin > 1000
  • SOFA < 11
  • Medical treatment during 48 hr according to de Institutional Medical center
  • With knowledge of the patient and / or his relatives responsible that it is a rescue treatment, in experimental phase.

Exclusion Criteria:

  • Pneumonia or ARDS caused by COVID-19, mild and moderate.
  • More than three organic failures
  • Expectations of survival less than 48 hr in the opinion of the treating service
  • Pneumonia or SIRA not caused by COVID-19
  • Advance will of the patient to refuse rescue or experimental treatment.

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): NCT04416139


Contacts
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Contact: Martin Iglesias, MD +1 52 55 5580097509 iglesias@drmartiniglesias.com
Contact: Carlos A Aguilar-Salinas, MD +1 52 55 54870900 ext 6321 caguilarsalinas@yahoo.com

Locations
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Mexico
Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán Recruiting
Mexico City, Mexico, 14080
Contact: Martin Iglesias, MD    +1 52 555580097509    iglesias@drmartiniglesias.com   
Contact: Carlos Aguilar-Salinas, MD    *1 52 55 54870900 ext 6321    caguilarsalinas@yahoo.com   
Sponsors and Collaborators
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
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Responsible Party: Martín Iglesias, Plastic surgeon, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
ClinicalTrials.gov Identifier: NCT04416139    
Other Study ID Numbers: SCI-3354-20-21-1
First Posted: June 4, 2020    Key Record Dates
Last Update Posted: June 4, 2020
Last Verified: June 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 Martín Iglesias, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran:
Mesenchymal Stem Cell
Additional relevant MeSH terms:
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Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Acute Lung Injury
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Lung Injury