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
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Condition or disease | Intervention/treatment | Phase |
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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 |
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 (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 |
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) |
- 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
- All-cause mortality [ Time Frame: Day 14 and day 28 ]at days 14 and 28 after randomization;
- 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;
- 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;
- Exploratory laboratory analysis [ Time Frame: 30 days ]variation in total and differential laboratory analysis.
- Duration of the period of hospitalization [ Time Frame: 30 days ]from hospital time in the intensive care unit (ICU)
- Duration of the period of ICU ventilation [ Time Frame: 30 days ]If applicable,will be measured the time of mechanical ventilation.
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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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).
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
Contact: Carolina Nonaka, phD | +55 (71) 3281-6970 | carolina.nonaka@hsr.com.br | |
Contact: Ingrid Barbosa, B.Sc | +551121098855 | nape@idor.org |
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 |
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) |
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 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
SARS-CoV-2 intravenous therapy extracellular vesicles ARDS mesenchymal cells |
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 |