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

August 18, 2023 updated by: D'Or Institute for Research and Education

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.

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

15

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

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

Study Contact

Study Contact Backup

  • Name: Ingrid Barbosa, B.Sc
  • Phone Number: +551121098855
  • Email: nape@idor.org

Study Locations

  • Brazil
    • Bahia
      • Salvador, Bahia, Brazil, 41253-190
        • Hospital Sao Rafael
        • Contact:
        • Contact:
        • Principal Investigator:
          • Bruno Souza, M.D
        • Principal Investigator:
          • Patricia Rocco, M.D

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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).

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: Double

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
28 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
All-cause mortality
Time Frame: Day 14 and day 28
at days 14 and 28 after randomization;
Day 14 and day 28
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;
Baseline, day 01, day 02 and day 07
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;
day 01, day 02, day 07, day 09, day 14 and day 29
Exploratory laboratory analysis
Time Frame: 30 days
variation in total and differential laboratory analysis.
30 days
Duration of the period of hospitalization
Time Frame: 30 days
from hospital time in the intensive care unit (ICU)
30 days
Duration of the period of ICU ventilation
Time Frame: 30 days
If applicable,will be measured the time of mechanical ventilation.
30 days

Collaborators and Investigators

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

Sponsor

D'Or Institute for Research and Education

Collaborators

Oswaldo Cruz Foundation
Rio de Janeiro State Research Supporting Foundation (FAPERJ)
Hospital Sao Rafael

Investigators

  • 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)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Estimated)

February 1, 2024

Primary Completion (Estimated)

June 1, 2025

Study Completion (Estimated)

June 1, 2025

Study Registration Dates

First Submitted

July 27, 2023

First Submitted That Met QC Criteria

August 18, 2023

First Posted (Actual)

August 21, 2023

Study Record Updates

Last Update Posted (Actual)

August 21, 2023

Last Update Submitted That Met QC Criteria

August 18, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EVs_2023

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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