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Extracellular Vesicles From Mesenchymal Cells in the Treatment of Acute Respiratory Failure

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ClinicalTrials.gov Identifier: NCT06002841
Recruitment Status : Not yet recruiting
First Posted : August 21, 2023
Last Update Posted : August 21, 2023
Sponsor:
Collaborators:
Hospital Sao Rafael
Rio de Janeiro State Research Supporting Foundation (FAPERJ)
Oswaldo Cruz Foundation
Information provided by (Responsible Party):
D'Or Institute for Research and Education

Study Description
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Brief Summary:
This is a phase I/II, randomized, double-blind, placebo-controlled clinical trial that will evaluate the safety and potential efficacy of therapy with extracellular vesicles (EVs) obtained from mesenchymal stromal cells (MSCs), patients with moderate to severe acute respiratory distress syndrome due to COVID-19 or other etiology. Participants will be allocated to receive EVs obtained from MSCs or placebo (equal volume of Plasma-Lyte A). Blinding will cover the participants, the multidisciplinary intensive care team and the investigators.

Condition or disease Intervention/treatment Phase
Severe Acute Respiratory Syndrome (SARS) Acute Respiratory Distress Syndrome (ARDS) Pneumonia Biological: intravenous treatment with EVs Biological: intravenous treatment with placebo solution Phase 1 Phase 2

Detailed Description:

The studied population will consist of 15 patients diagnosed with acute respiratory failure syndrome admitted to the intensive care unit of Hospital São Rafael. This research aims to assess the safety and potential effectiveness of intravenous therapy using extracellular vesicles derived from mesenchymal cells in patients with moderate to severe acute respiratory distress syndrome. The treatment group will receive intravenous administration of extracellular vesicles obtained from mesenchymal cells, while the control group will receive a placebo.

EV group: will consist of 10 participants who will receive two infusions of 25 mL of the investigational product (Plasma-Lyte A solution containing EVs obtained from MSCs), intravenously, at intervals of 48 h.

Placebo group: will consist of 5 participants who will receive an equal volume of Plasma-Lyte A, intravenously, following the same schedule as the IV group: two infusions with an interval of 48 hours.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking Description: The treatment and placebo solutions will be indistinguishable in terms of their appearance. Stringent protocols will be established to guarantee that the physicians responsible for assessing patient safety, evaluating efficacy outcomes, and conducting laboratory analyses will be blinded to the randomization codes.
Primary Purpose: Treatment
Official Title: Extracellular Vesicles From Mesenchymal Cells in the Treatment of Acute Respiratory Failure Associated With SARS-CoV-2 and Other Etiologies: a Clinical Trial, Randomized, Double-blind.
Estimated Study Start Date : February 1, 2024
Estimated Primary Completion Date : June 1, 2025
Estimated Study Completion Date : June 1, 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: EV group
will consist of 10 participants who will receive two infusions of 25 mL of the investigational product (Plasma-Lyte A solution containing EVs obtained from MSCs), intravenously, at intervals of 48 h.
 Biological: intravenous treatment with EVs
intravenous treatment with extracellular vesicles
Placebo Comparator: Placebo group
will consist of 5 participants who will receive an equal volume of Plasma-Lyte A, intravenously, following the same schedule as the IV group: two infusions with an interval of 48 hours.
 Biological: intravenous treatment with placebo solution
intravenous treatment with placebo solution (without extracellular vesicles)


Outcome Measures
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Primary Outcome Measures :
  1. Measure administration of extracellular vesicles (EVs) up to 28 days [ Time Frame: 28 days ]
    Measure as reported adverse events up to 28 days after treatment or placebo administration to evaluate safety of treatment


Secondary Outcome Measures :
  1. All-cause mortality [ Time Frame: Day 14 and day 28 ]
    at days 14 and 28 after randomization;

  2. Variation in the Ratio PaO2/FiO2 [ Time Frame: Baseline, day 01, day 02 and day 07 ]
    PaO2 (arterial partial pressure of oxygen)/FiO2 (fraction of inspired oxygen) on the day of randomization and at 24 hours, 48 hours and 7 days after the first infusion;

  3. Variation in the SOFA index [ Time Frame: day 01, day 02, day 07, day 09, day 14 and day 29 ]
    Variation in the SOFA index (Assessment of Sequential Organ Failure) at the time of randomization and during follow-up until discharge from the intensive care unit;

  4. Exploratory laboratory analysis [ Time Frame: 30 days ]
    variation in total and differential laboratory analysis.

  5. Duration of the period of hospitalization [ Time Frame: 30 days ]
    from hospital time in the intensive care unit (ICU)

  6. Duration of the period of ICU ventilation [ Time Frame: 30 days ]
    If applicable,will be measured the time of mechanical ventilation.


Eligibility Criteria
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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:

  • Age >= 18 years old;
  • Chest CT radiological image with ground-glass opacities or chest X-ray with - bilateral infiltrates characteristic of pulmonary edema;
  • In invasive mechanical ventilation with PEEP 5 cm H2O and PaO2/FiO2<250mmHg;
  • Respiratory failure not explained by cardiac causes or fluid overload.

Exclusion Criteria:

  • Unable to provide informed consent;
  • Pregnancy or breastfeeding;
  • Patients with active malignancy who have received chemotherapy in the last 2 years;
  • Life expectancy of less than 6 months or in exclusive palliative care;
  • Severe liver failure, with a Child-Pugh score > 12;
  • Previous renal failure: patients already undergoing dialysis or patients with GFR < 30ml/min/1.73 m2
  • Clinical or radiological suspicion of tuberculosis;
  • Chronic respiratory failure;
  • Use of ECMO;
  • Moribund (high probability of death within the next 48 hours).
Contacts and Locations
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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): NCT06002841


Contacts
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Contact: Carolina Nonaka, phD +55 (71) 3281-6970 carolina.nonaka@hsr.com.br
Contact: Ingrid Barbosa, B.Sc +551121098855 nape@idor.org

Locations
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Brazil
Hospital São Rafael
Salvador, Bahia, Brazil, 41253-190
Contact: Carolina Nonaka, phD    +55 (71) 3281-6970    carolina.nonaka@hsr.com.br   
Contact: Tânia Aravena, B.Sc    +55 (71) 98748-6532    tania.mariela@hsr.com.br   
Principal Investigator: Bruno Souza, M.D         
Principal Investigator: Patricia Rocco, M.D         
Sponsors and Collaborators
D'Or Institute for Research and Education
Hospital Sao Rafael
Rio de Janeiro State Research Supporting Foundation (FAPERJ)
Oswaldo Cruz Foundation
Investigators
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Principal Investigator: Bruno Souza, M.D Instituto D'Or de Pesquisa e Ensino (IDOR), Salvador, Brazil
Principal Investigator: Patrícia Rocco, M.D Universidade Federal do Rio de Janeiro (UFRJ)
More Information
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Publications:

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Responsible Party: D'Or Institute for Research and Education
ClinicalTrials.gov Identifier: NCT06002841    
Other Study ID Numbers: EVs_2023
First Posted: August 21, 2023    Key Record Dates
Last Update Posted: August 21, 2023
Last Verified: August 2023
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 D'Or Institute for Research and Education:
SARS-CoV-2
intravenous therapy
extracellular vesicles
ARDS
mesenchymal cells
Additional relevant MeSH terms:
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Severe Acute Respiratory Syndrome
Respiratory Distress Syndrome
Respiratory Distress Syndrome, Newborn
Respiratory Insufficiency
Acute Lung Injury
Syndrome
Disease
Pathologic Processes
Respiratory Tract Infections
Infections
Lung Diseases
 Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Lung Injury
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases