Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

Can stem cell vesicles save lives in severe ARDS?

NCT ID NCT05354141

Disease control Sponsor: Direct Biologics, LLC Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 3 trial tests whether a single intravenous dose of ExoFlo, made from bone marrow stem cell vesicles, can lower the death rate in hospitalized adults with moderate-to-severe ARDS. About 970 participants will receive either ExoFlo or a placebo. The main goal is to see if ExoFlo reduces deaths within 60 days and helps patients get off ventilators and oxygen faster.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
ExoFlo (bone marrow stem cell derived extracellular vesicles)
What this could lead to
If it works, this could provide a new treatment to reduce deaths and speed recovery in patients with severe lung inflammation (ARDS).
What could go wrong
This is still an experimental treatment. Even in phase 3, it may not prove better than placebo, and side effects from the intravenous vesicles are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 970 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2022

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Men and women aged 18-75 years of age 2. Presence of the following criteria for moderate to severe ARDS as defined by the Berlin Criteria within 24 hours of the first infustion: 1. Onset within 7 days of known clinical insult or requiring increasing respiratory rate, increasing oxygen flows, or increased work of breathing, and 2. Bilateral lung opacities not fully explained by pleural effusions, atelectasis, or nodules, and 3. PaO2/FiO2 (P/F ratio) ≤ 200 mm Hg, and 4. Invasive or noninvasive ventilation with a minimum PEEP 5 cm H2O or minimum of continuous positive airway pressure (CPAP) 5 cm H2O, or High Flow Nasal Oxygen at ≥ 30 L/min, and 5. Respiratory failure not fully explained by cardiac failure or fluid overload. Exclusion Criteria: 1. Lack of signed and dated informed consent form (either by the individual or by the individual's healthcare proxy). 2. Stated unwillingness to comply with all study procedures and availability for the duration of the study 3. Vulnerable populations such as pregnant patients, children, individuals with severe physical or mental disabilities who cannot provide meaningful consent. 4. Active malignancy requiring treatment within the last two years, with the exception of non-melanoma skin cancers. 5. 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. 6. Duration of mechanical ventilation exceeds 3 days or 72 hours from diagnosis of ARDS. 7. ALT or AST \> 8 x Upper Limit of Normal (ULN). 8. Documented history of cirrhosis. 9. DNR order, as in electing not to receive chest compressions, cardiac defibrillation, cardiac drugs, or intubation. 10. Moribund-expected survival \< 24 hours. 11. Severe metabolic disturbances at randomization (e.g., ketoacidosis, pH \< 7.2) 12. Patient currently connected to Extracorporeal Membrane Oxygenation at initiation of screening. 13. If the candidate, either a male or female of reproductive potential, is unwilling to two methods of highly effective birth control contraception such as condoms with oral contraceptive pill or choose to remain abstinent if already practicing abstinence during the screening period. The required duration of usage of double method OR maintenance of abstinence must include the time from the beginning of the screening period until Day 61, day of withdrawal or early termination 14. Use of investigational COVID-19 agents or any other investigational agents within 30 days prior to the first dose.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Acute respiratory distress syndrome are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

acute respiratory distress syndrome adult acute respiratory distress syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Acute respiratory distress syndrome ARDS

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    32 sites. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Direct Biologics Investigational Site

    RECRUITING

    Phoenix, Arizona, 85012, United States

  • Direct Biologics Investigational Site

    RECRUITING

    Little Rock, Arkansas, 72205, United States

  • Direct Biologics Investigational Site

    RECRUITING

    Davis, California, 95817, United States

  • Direct Biologics Investigational Site

    RECRUITING

    Irvine, California, 92627, United States

  • Direct Biologics Investigational Site

    RECRUITING

    Sacramento, California, 95817, United States

  • Direct Biologics Investigational Site

    RECRUITING

    Washington D.C., District of Columbia, 20010, United States

  • Direct Biologics Investigational Site

    RECRUITING

    Jacksonville, Florida, 32224, United States

  • Direct Biologics Investigational Site

    RECRUITING

    Boise, Idaho, 83712, United States

  • Direct Biologics Investigational Site

    RECRUITING

    Iowa City, Iowa, 52242, United States

  • Direct Biologics Investigational Site

    RECRUITING

    Silver Spring, Maryland, 20910, United States

  • Direct Biologics Investigational Site

    RECRUITING

    Boston, Massachusetts, 02115, United States

  • Direct Biologics Investigational Site

    RECRUITING

    Burlington, Massachusetts, 01805, United States

  • Direct Biologics Investigational Site

    RECRUITING

    Springfield, Massachusetts, 01199, United States

  • Direct Biologics Investigational Site

    RECRUITING

    Detroit, Michigan, 48202, United States

  • Direct Biologics Investigational Site

    RECRUITING

    Rochester, Minnesota, 55905, United States

  • Direct Biologics Investigational Site

    RECRUITING

    Jackson, Mississippi, 39202, United States

  • Direct Biologics Investigational Site

    RECRUITING

    Flushing, New York, 11368, United States

  • Direct Biologics Investigational Site

    RECRUITING

    Queens, New York, 11040, United States

  • Direct Biologics Investigational Site

    RECRUITING

    The Bronx, New York, 10467, United States

  • Direct Biologics Investigational Site

    RECRUITING

    Durham, North Carolina, 27710, United States

  • Direct Biologics Investigational Site

    RECRUITING

    Winston-Salem, North Carolina, 27157, United States

  • Direct Biologics Investigational Site

    RECRUITING

    Cincinnati, Ohio, 45219, United States

  • Direct Biologics Investigational Site

    RECRUITING

    Cleveland, Ohio, 44106, United States

  • Direct Biologics Investigational Site

    RECRUITING

    Portland, Oregon, 97239, United States

  • Direct Biologics Investigational Site

    RECRUITING

    Charleston, South Carolina, 29425, United States

  • Direct Biologics Investigational Site

    RECRUITING

    Knoxville, Tennessee, 37996, United States

  • Direct Biologics Investigational Site

    RECRUITING

    Nashville, Tennessee, 37235, United States

  • Direct Biologics Investigational Site

    RECRUITING

    Dallas, Texas, 75246, United States

  • Direct Biologics Investigational Site

    RECRUITING

    Fort Worth, Texas, 76104, United States

  • Direct Biologics Investigational Site

    RECRUITING

    Houston, Texas, 77030, United States

  • Direct Biologics Investigational Site

    NOT_YET_RECRUITING

    Murray, Utah, 84107, United States

  • Direct Biologics Investigational Site

    RECRUITING

    Salt Lake City, Utah, 84101, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.