Status:
COMPLETED
Mesenchymal Stromal Cells For Acute Respiratory Distress Syndrome
Lead Sponsor:
Michael A. Matthay
Collaborating Sponsors:
United States Department of Defense
Harborview Injury Prevention and Research Center
Conditions:
Respiratory Distress Syndrome, Adult
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This is a Phase 2b, randomized, double-blind, placebo-controlled, multi-center study to assess the safety and efficacy of a single dose of Allogeneic Bone Marrow-derived Human Mesenchymal Stromal Cell...
Detailed Description
This clinical study design is a randomized, double-blinded, placebo-controlled Phase 2b clinical trial using a 10 million cell/kg dose of human Mesenchymal Stromal Cells (hMSCs). Subjects will be rand...
Eligibility Criteria
Inclusion
- Patients will be eligible for inclusion if they meet all of the below criteria within 14 days of initial ICU admission. Criteria 1-3 must all be present within a 24-hour time period and at the time of enrollment:
- Acute onset (defined below) of:
- A need for positive pressure ventilation by an endotracheal or tracheal tube with a PaO2/FiO2 ratio \<250 mmHg and ≥5 cm H2O positive end-expiratory airway pressure (PEEP), as per the Berlin Criteria.
- Bilateral infiltrates consistent with pulmonary edema (defined below) on the frontal chest radiograph, or bilateral ground glass opacities on a chest CT scan.
- No clinical evidence of left atrial hypertension as a primary explanation for the bilateral pulmonary infiltrates.
- If the cause of ARDS is trauma, additional inclusion criteria will include ONE of the following relevant risk factors for developing ARDS:
- Hypotension (systolic blood pressure\[SBP\] \< 90 mmHg) in the field or in the first 24 h after injury, or
- Transfusion of 3 units of blood products in the first 24 hours following injury, or
- Meets the new Critical Administration Threshold (CAT) criteria with at least 3 units of blood in one hour, or
- Blunt or penetrating torso trauma, or
- Long bone fractures, or
- The highest level of institutional trauma activation
Exclusion
- Age less than 18 years
- Greater than 72 hours since first meeting ARDS criteria per the Berlin definition of ARDS
- Greater than 14 days since initial ICU admission
- Inability to administer study product within 14 days of ICU admission
- PaO2/FiO2 ≥ 250 mmHg after consent obtained and before study product is administered
- Unable to obtain informed consent/no surrogate available
- Pregnant or lactating
- In custody of law enforcement officials
- Burns \> 20% of total body surface area
- WHO Class III or IV pulmonary hypertension
- History of cancer treatment in the last 2 years except for non-melanotic skin cancers
- Underlying medical condition for which 6-month mortality is estimated to be \> 50%
- Moribund patient not expected to survive 24 hours
- Advanced chronic liver disease (Child-Pugh Score \> 12)
- Severe chronic respiratory disease with the use of home oxygen
- Severe traumatic brain injury - defined as:
- A patient who has undergone intracranial neurosurgical intervention for monitoring or therapy (intracranial pressure monitoring, external ventricular drain, craniotomy), or
- Intracranial injury by head CT (does not include patients with minimal subarachnoid injury and/or minor skull fracture), or
- Post-resuscitation Glasgow Coma Score (GCS) \< 9 assessed after sedation interruption, or
- Non-survivable head injury as assessed by neurosurgery
- Evidence of anoxic brain injury
- History of stroke within the last 3 years
- No intent/unwillingness to follow lung protective ventilation strategy
- Currently receiving extracorporeal life support (ECLS) or high-frequency oscillatory ventilation (HFOV)
- Anticipated extubation within 24 hours of enrollment
- Clinical evidence of left atrial hypertension as measured by a pulmonary arterial wedge pressure \> 18mmHg or left ventricular failure measured by an echocardiogram with a left ventricular ejection fraction less than 40%. Clinical judgement will determine if either of these measurements needs to be carried out.
Key Trial Info
Start Date :
November 26 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2024
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT03818854
Start Date
November 26 2019
End Date
June 30 2024
Last Update
December 4 2025
Active Locations (7)
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1
University of California Davis Medical Center
Sacramento, California, United States, 95817
2
Zuckerberg San Francisco General Hospital and Trauma Center
San Francisco, California, United States, 94110
3
University of California San Francisco
San Francisco, California, United States, 94143
4
Oregon Health & Science University
Portland, Oregon, United States, 97239