This is a phase IIa, dose-ranging, proof-of-concept study of MRG-001 in patients with ARDS.
The aim is to determine the safety and preliminary efficacy of MRG-001 across two dose ranges.
Chest x-ray (CXR)* revealing bilateral infiltrates involving a minimum of three quadrants on frontal chest radiograph, consistent with pulmonary edema or bilateral ground glass opacities not fully explained by effusions, lobar or lung collapse, nodules, atelectasis or other etiology of infiltrates not due to ARDS.
PaO2/FiO2 < 300.
Requiring respiratory support [defined as mechanical ventilation, non-invasive ventilation (NIV) or high flow nasal canula (HFNC)] If on ventilator, settings must include positive end-expiratory pressure (PEEP) or continuous positive airway pressure (CPAP) ≥5 cm H2O.
Age less than 18 years.
Infiltrates with etiology suspected of mimicking ARDS, ie; Pulmonary Edema due to Congestive Heart Failure (CHF). (A Pulmonary Arterial Wedge Pressure (PAWP) of < 18 for >12 hours would rule out suspected CHF).
Pregnancy documented or suspected in women of child bearing potential, unless ruled out by a negative pregnancy test during screening or breast feeding.
Hypersensitivity to either of the components of MRG-001.
Parallel
MRG-001 (Low-dose)
DrugMRG-001 is subcutaneously administered.
MRG-001 (High-dose)
DrugMRG-001 is subcutaneously administered.
Placebo
Other interventionSaline placebo will be administered subcutaneously based on bodyweight and similar dose as the treatment group.
Hemopoietic stem cell mobilization
The primary efficacy endpoint is the absolute change of hematopoietic stem cell mobilization (CD34+ cells) calculated as cells/μl at the peak of mobilization at 12 hours compared to baseline after MRG-001 injection. degree of hematopoietic stem cell mobilization (CD34+, cells/μl) measured as a longitudinal outcome over the first 24 hours after after MRG-001 injection.
Organ Failure
The primary safety endpoint is organ system failure free days to day 28. Patients will be monitored daily for 28 days for signs of the failure of non-pulmonary organs and systems. The following non-pulmonary organ system failures will be assessed: circulatory, coagulation, hepatic and renal failure.
Pharmacokinetics
Change in the trough concentration (Ctrough) of tacrolimus in ng/mL in whole blood during the course of treatment.
Pharmacokinetics
Change in the trough concentration (Ctrough) of plerixafor in ng/mL in plasma during the course of treatment.
Pharmacodynamics
Change in absolute numbers or percentages from baseline in circulating stem cells and immune cells measured by flow cytometry
Cytokine Changes
Change from baseline in serum cytokines including IL-1β, IL-2, IL-4, IL-6, IL-8, IL-10, IL-17, IL-18, IFN- γ, TNF-α.
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MedRegen LLC
Lead sponsor
Vanderbilt University Medical Center
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
