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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 61 days
Awards & highlights
Study 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 belowSelect...
I have been diagnosed with severe lung distress recently.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 61 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~61 days
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 moreSide effects data
From 2021 Phase 2 trial • 102 Patients • NCT0449324235%
Acute Respiratory Failure
26%
Anxiety
24%
Hypotension
24%
Hypokalaemia
15%
Respiratory Failure
12%
Cardiac Arrest
12%
Hyperkalaemia
9%
Constipation
9%
Hyperglycaemia
9%
Leukocytosis
9%
Anaemia
9%
Pyrexia
9%
Agitation
6%
Myalgia
6%
Hypoalbuminaemia
6%
Hypophosphataemia
6%
Thrombocytopenia
6%
Type 2 Diabetes Mellitus
6%
Atrial Fibrillation
6%
Upper Respiratory Tract Infection
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%
Atrial Flutter
3%
Hyperphosphataemia
3%
Nasal Congestion
3%
Musculoskeletal Chest Pain
3%
Bradycardia
3%
Myocardial Ischaemia
3%
Tachycardia
3%
Hypocalcaemia
3%
Oedema Peripheral
3%
Nausea
3%
Encephalopathy
3%
Oropharyngeal Pain
3%
Diarrhoea
3%
Diabetes Mellitus
3%
Pharyngeal Haemorrhage
3%
Pneumothorax
3%
Fall
3%
Fungal Skin Infection
3%
Malnutrition
3%
Fungaemia
3%
Hypernatraemia
3%
Rales
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
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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not experienced major physical trauma or injuries in the last 2 days.Your ALT or AST levels are more than 8 times the normal limit.You have been on a breathing machine for more than 3 days since being diagnosed with ARDS.You are expected to live for less than 24 hours.You have severe problems with how your body processes energy, like ketoacidosis with a low pH level.I am between 18 and 75 years old.I have been diagnosed with severe lung distress recently.I haven't needed treatment for cancer, except for non-melanoma skin cancer, in the last 2 years.I am willing and able to follow all study procedures for its duration.I have been diagnosed with cirrhosis.You have chosen not to receive certain emergency medical treatments like chest compressions, defibrillation, or intubation.I am unwilling to use two effective birth control methods or remain abstinent.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo
- Group 2: Experimental Dose
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are medical patients currently being recruited for this experiment?
"According to the listing on clinicaltrials.gov, this trial is still enrolling patients. The trial was initially posted on 7/1/2022 and was last updated on 8/25/2022. The study is looking for 400 individuals at a single site."
Answered by AI
Are elderly patients qualified to participate in this clinical trial?
"The age limit for this trial is 85 years old, and any person above the age of 18 is eligible."
Answered by AI
Are there any potential dangers associated with EXOFLO?
"EXOFLO's safety is largely supported by data, so it received a score of 3."
Answered by AI
Who can take part in this clinical research?
"This study requires 400 participants who are currently experiencing respiratory distress syndrome and are between the ages of 18 and 85. In addition to meeting these requirements, potential participants must also:- Be willing and able to comply with the study's planned procedures- Be male or non-pregnant female- Be of childbearing potential and agree to use an effective form of contraception throughout the study period- Meet the criteria for either severe or critical COVID-19- Have evidence of SARS-CoV-2 infection- Be experiencing respiratory failure- Be admitted to the hospital with symptoms suggestive of COVID"
Answered by AI
How many patients will be participating in this clinical trial?
"Yes, the trial is still open and recruiting patients. The trial was first posted on 7/1/2022 and was most recently edited on 8/25/2022. The study is currently looking for 400 participants from 1 location."
Answered by AI
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