EXTINGuish ARDS: The Safety and Effectiveness of the ExoFlo Investigational Infusion Treatment for Patients with Moderate to Severe Acute Respiratory Distress Syndrome
The EXTINGuish ARDS study is a phase 3 clinical trial to evaluate the safety and effectiveness of ExoFlo, an investigational infusion treatment for patients with moderate to severe acute respiratory distress syndrome (ARDS).
About
Hospitalized patients with moderate to severe ARDS may be eligible for the EXTINGuish ARDS study, where the effectiveness of ExoFlo as a regenerative medical therapy will be compared to placebo via an intravenous infusion treatment.
ExoFlo is isolated from human bone marrow mesenchymal stem cells donors and has been demonstrated to reduce inflammation and promote tissue repair in humans. Patients enrolled in the control group will receive placebo, as per their institutional standard of care methods. Patients assigned to the ExoFlo group will receive ExoFlo in addition to standard-of-care methods for treatment.
Eligibility Criteria
Inclusion Criteria
- 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 infusion:
- Onset within 7 days of known clinical onset or requiring increasing respiratory rate, increasing oxygen flows or increased work of breathing
- Bilateral lung opacities not fully explained by pleural effusions, atelectasis or nodules
- PaO2/FiO2 (P/F ratio) ≤ 200 mmHg
- 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
- Respiratory failure not fully explained by cardiac failure or fluid overload
Exclusion Criteria
- Unwillingness to comply with all study procedures and availability for the duration of the study
- Pregnant patients, children and individuals with severe physical or mental disabilities who are unable to provide meaningful consent
- Patient has undergone major physical trauma in the prior 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 diagnosed at time of screening.
- Duration of mechanical ventilation exceeds 3 days or 72 hours from diagnosis of ARDS.
- Moribund—expected survival < 24 hours
Primary Investigator
Dr. Bryan Collier is an acute care surgeon with over 20 years of clinical and research experience. He is a professor at the Virginia Tech Carilion School of Medicine and is the chief of Trauma Surgery at Carilion Clinic. He is board certified by the American Board of Surgery for Critical Care and General Surgery. He completed his fellowship at the Vanderbilt University Medical Center and his internship and residency at Memorial Medical Center.
Contact Information
Leila Zavar, B.S.
Clinical Research Coordinator
