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Extracellular Vesicles

Extracellular Vesicle Treatment for Acute Respiratory Distress Syndrome

Phase 3
Recruiting
Led By Vikram Sengupta, MD
Research Sponsored by Direct Biologics, LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Presence of moderate to severe ARDS as defined by the Berlin Criteria within 24 hours of the first infusion, including specific criteria related to onset, lung opacities, P/F ratio, ventilation, and respiratory failure
Be older than 18 years old
Must not have
Stated unwillingness to comply with all study procedures and availability for the duration of the study
Major physical trauma in the last 2 days, including motor vehicle accidents, assaults, mechanical falls with sequelae of significant bleeding or craniofacial bruising, and surgeries, such that not one or more injury may be undiagnosed at time of screening
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 61 days
Awards & highlights

Summary

This trial is testing whether ExoFlo, a therapy made from extracellular vesicles, can help treat moderate to severe ARDS caused by COVID-19.

Who is the study for?
This trial is for adults aged 18-75 with moderate-to-severe ARDS, as defined by the Berlin Criteria, and who have been on a ventilator for less than 3 days. Excluded are those with certain liver enzyme levels, severe disabilities, pregnant women, recent investigational drug use, active malignancy requiring treatment (except skin cancer), unwillingness to follow study procedures or use effective birth control.Check my eligibility
What is being tested?
The EXTINGUISH ARDS trial tests the safety and effectiveness of ExoFlo—an IV therapy using extracellular vesicles from bone marrow stem cells—against a saline placebo in hospitalized patients with moderate-to-severe ARDS to see if it can improve their lung function.See study design
What are the potential side effects?
While specific side effects of ExoFlo are not listed here, potential risks may include reactions at the infusion site, immune responses to foreign substances in the body, or complications related to underlying conditions worsened by additional treatments.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with severe lung distress recently.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I am willing and able to follow all study procedures for its duration.
Select...
I have not experienced major physical trauma or injuries in the last 2 days.
Select...
I have been diagnosed with cirrhosis.
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I am unwilling to use two effective birth control methods or remain abstinent.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~61 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 61 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Evaluation of 60-day All-cause Mortality
Secondary outcome measures
ICU free days
Incidence of Treatment Emergent Serious Adverse Events (TESAEs)
Oxygen free days
+2 more

Side effects data

From 2021 Phase 2 trial • 102 Patients • NCT04493242
35%
Acute Respiratory Failure
26%
Anxiety
24%
Hypokalaemia
24%
Hypotension
15%
Respiratory Failure
12%
Cardiac Arrest
12%
Hyperkalaemia
9%
Hyperglycaemia
9%
Constipation
9%
Leukocytosis
9%
Anaemia
9%
Pyrexia
9%
Agitation
6%
Atrial Fibrillation
6%
Hypoalbuminaemia
6%
Myalgia
6%
Upper Respiratory Tract Infection
6%
Hypophosphataemia
6%
Thrombocytopenia
6%
Type 2 Diabetes Mellitus
6%
Fluid Overload
6%
Pneumonia
6%
Confusional State
6%
Hypertension
6%
Embolism
6%
Sepsis
6%
Acute Kidney Injury
6%
Multiple Organ Dysfunction Syndrome
6%
Hypothermia
3%
Hyperphosphataemia
3%
Diabetes Mellitus
3%
Rales
3%
Atrial Flutter
3%
Oropharyngeal Pain
3%
Nasal Congestion
3%
Musculoskeletal Chest Pain
3%
Bradycardia
3%
Myocardial Ischaemia
3%
Tachycardia
3%
Hypocalcaemia
3%
Oedema Peripheral
3%
Nausea
3%
Encephalopathy
3%
Diarrhoea
3%
Pharyngeal Haemorrhage
3%
Pneumothorax
3%
Fall
3%
Fungal Skin Infection
3%
Malnutrition
3%
Fungaemia
3%
Hypernatraemia
3%
Syncope
3%
Cough
3%
Abdominal Pain
3%
Pancreatitis
3%
Renal Ischemia
3%
Renal Tubular Necrosis
3%
Blood Glucose Increased
3%
Acidosis
3%
Septic Shock
3%
Dyspepsia
3%
Wound Infection
3%
Troponin I Increased
3%
Dehydration
3%
Epistaxis
3%
Enterococcal Infection
100%
80%
60%
40%
20%
0%
Study treatment Arm
Experimental Dose 1
Placebo
Experimental Dose 2

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Experimental DoseExperimental Treatment1 Intervention
Normal saline 85 mL and ExoFlo 15 mL
Group II: PlaceboPlacebo Group1 Intervention
Normal saline 100 mL
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
ExoFlo
2020
Completed Phase 2
~110

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Extracellular vesicles (EVs) derived from bone marrow mesenchymal stem cells (BMSCs) are being investigated for their potential to treat Acute Respiratory Distress Syndrome (ARDS). These EVs contain proteins, microRNAs, and other molecules that can modulate immune responses, reduce inflammation, and promote lung tissue repair. Specifically, they help in reducing pulmonary vascular leakage, facilitating the repair of the pulmonary epithelium, and attenuating acute lung injury. This is crucial for ARDS patients as it addresses the underlying inflammation and tissue damage that characterize the syndrome, potentially improving outcomes and reducing mortality. Other common treatments for ARDS include systemic glucocorticoids to reduce inflammation and supportive care like mechanical ventilation to maintain adequate oxygenation.
MiR-223-3p-loaded exosomes from bronchoalveolar lavage fluid promote alveolar macrophage autophagy and reduce acute lung injury by inhibiting the expression of STK39.Differential Lung Protective Capacity of Exosomes Derived from Human Adipose Tissue, Bone Marrow, and Umbilical Cord Mesenchymal Stem Cells in Sepsis-Induced Acute Lung Injury.Exosomes Derived From Alveolar Epithelial Cells Promote Alveolar Macrophage Activation Mediated by miR-92a-3p in Sepsis-Induced Acute Lung Injury.

Find a Location

Who is running the clinical trial?

Direct Biologics, LLCLead Sponsor
10 Previous Clinical Trials
319 Total Patients Enrolled
Vikram Sengupta, MDPrincipal InvestigatorDirect Biologics
8 Previous Clinical Trials
283 Total Patients Enrolled
Bill AranaStudy DirectorDirect Biologics, LLC
9 Previous Clinical Trials
299 Total Patients Enrolled

Media Library

ExoFlo (Extracellular Vesicles) Clinical Trial Eligibility Overview. Trial Name: NCT05354141 — Phase 3
Acute Respiratory Distress Syndrome Research Study Groups: Placebo, Experimental Dose
Acute Respiratory Distress Syndrome Clinical Trial 2023: ExoFlo Highlights & Side Effects. Trial Name: NCT05354141 — Phase 3
ExoFlo (Extracellular Vesicles) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05354141 — Phase 3
~242 spots leftby Mar 2025