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A Phase 3 Study to Assess the Safety and Efficacy of Invimestrocel Therapy in Subjects with Acute Respiratory Distress Syndrome (ARDS) Due to Pneumonia (REVIVE-ARDS)

Reducing Mechanical Ventilation through administration of Invimestrocel in patients with ARDS (REVIVE-ARDS)

Oe Tetsuya

HEALIOS K.K.

1-1-2, Yurakucho, Chiyoda-ku, Tokyo

t.oe@healios.jp

Oe Tetsuya

HEALIOS K.K.

1-1-2, Yurakucho, Chiyoda-ku, Tokyo

+81-3-4590-8006

t.oe@healios.jp

Pending

June. 01, 2026

Interventional

randomized controlled trial

double blind

placebo control

parallel assignment

treatment purpose

Diagnosis of pneumonia, as determined by the investigator
Diagnosis of new acute onset moderate to severe ARDS, within the 48 hours prior to planned first dose of IP, as defined by the Berlin criteria, with all of the following criteria confirmed present within the same 24 hour period during screening:
Receiving invasive mechanical ventilation (IMV) with positive end-expiratory airway pressure (PEEP) >=5cm H2O;
Bilateral opacities on chest radiograph, computed tomography, or ultrasound;
Hypoxemic respiratory failure not fully explained by cardiac failure or fluid overload; and,
Arterial oxygen partial pressure (PaO2) to fractional inspired oxygen (FiO2) ratio (PaO2/FiO2) of <200 mmHg (27kPa), and;
Subject or legally authorized representative (LAR) must provide informed consent after the nature of the study and the disclosure of his/her data has been explained.

Unable to receive investigational product (IP) within 48 hours of meeting the ARDS diagnosis criteria as defined in inclusion criterion 3. The clock starts when the last criterion is met;
Meet the CDC definition of ventilator-associated pneumonia (VAP);
Invasive mechanical ventilation for greater than 72 hours prior to fulfillment of ARDS criteria;
Noninvasive ventilation (NIV) or High-Flow Nasal Cannula (HFNC) and PF<200 (or SPO2/FiO2 <235) for greater than 48 hours prior to IMV

Both

Acute Respiratory Distress Syndrome (ARDS)

A single dose of invimestrocel therapy (900 million cells per dose) or matched placebo by intravenous (IV) infusion

D012128

To evaluate the efficacy and safety of invimestrocel therapy as a treatment for subjects with ARDS due to pneumonia.

To evaluate the effect on all-cause mortality among all trial subjects as well as to evaluate the tolerability, pulmonary function, and quality of life (QoL) among survivors associated with invimestrocel therapy as a treatment for subjects with ARDS due to pneumonia.

+81-96-351-8000

No

US