Brief Summary

To evaluate the safety and efficacy of intravenous (IV) administration of bone marrow mesenchymal stem cell derived extracellular vesicles (EVs), ExoFlo, versus placebo for the treatment of hospitalized patients with moderate-to-severe Acute Respiratory Distress Syndrome (ARDS).

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

970

participants targeted

Target at P75+ for phase_3

Timeline

20mo left

Started Jul 2022

Longer than P75 for phase_3

Geographic Reach

1 country

32 active sites

Status

recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

5.5 years study duration

Study Progress70%

Jul 2022Dec 2027

First Submitted

Initial submission to the registry

April 27, 2022

Completed

2 days until next milestone

First Posted

Study publicly available on registry

April 29, 2022

Completed

2 months until next milestone

Study Start

First participant enrolled

July 1, 2022

Completed

5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2027

Expected

1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

February 23, 2026

Status Verified

February 1, 2026

Enrollment Period

5.4 years

First QC Date

April 27, 2022

Last Update Submit

February 20, 2026

Conditions

Acute Respiratory Distress Syndrome ARDS

Keywords

ExoFloExtracellular VesiclesExosomeARDS

Outcome Measures

Primary Outcomes (1)

Evaluation of 60-day All-cause Mortality
To evaluate the 60-day mortality rate for IMP 15mL as a treatment for moderate-to-severe ARDS compared to placebo. Reducing the mortality rate for hospitalized patients with moderate-to-severe ARDS is a measure of the treatment effect.
60 days

Secondary Outcomes (5)

Time to death
60 days
Ventilator-free days (VFDs)
Day 29
Oxygen free days
Day 29
ICU free days
Day 29
Incidence of Treatment Emergent Serious Adverse Events (TESAEs)
61 days

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Normal saline 100 mL

Other: Intravenous normal saline

Experimental Dose

EXPERIMENTAL

Normal saline 85 mL and ExoFlo 15 mL

Biological: ExoFlo

Interventions

ExoFloBIOLOGICAL

Intravenous administration of bone marrow mesenchymal stem cell derived extracellular vesicles

Experimental Dose

Intravenous normal salineOTHER

Placebo

Eligibility Criteria

Age18 Years - 75 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Men and women aged 18-75 years of age
Presence of the following criteria for moderate to severe ARDS as defined by the Berlin Criteria within 24 hours of the first infustion:
Onset within 7 days of known clinical insult or requiring increasing respiratory rate, increasing oxygen flows, or increased work of breathing, and
Bilateral lung opacities not fully explained by pleural effusions, atelectasis, or nodules, and
PaO2/FiO2 (P/F ratio) ≤ 200 mm Hg, and
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
Respiratory failure not fully explained by cardiac failure or fluid overload.

You may not qualify if:

Lack of signed and dated informed consent form (either by the individual or by the individual's healthcare proxy).
Stated unwillingness to comply with all study procedures and availability for the duration of the study
Vulnerable populations such as pregnant patients, children, individuals with severe physical or mental disabilities who cannot provide meaningful consent.
Active malignancy requiring treatment within the last two years, with the exception of non-melanoma skin cancers.
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.
Duration of mechanical ventilation exceeds 3 days or 72 hours from diagnosis of ARDS.
ALT or AST \> 8 x Upper Limit of Normal (ULN).
Documented history of cirrhosis.
DNR order, as in electing not to receive chest compressions, cardiac defibrillation, cardiac drugs, or intubation.
Moribund-expected survival \< 24 hours.
Severe metabolic disturbances at randomization (e.g., ketoacidosis, pH \< 7.2)
Patient currently connected to Extracorporeal Membrane Oxygenation at initiation of screening.
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
Use of investigational COVID-19 agents or any other investigational agents within 30 days prior to the first dose.

Contact the study team to confirm eligibility.