MRG-001 as an Immunoregulatory and Regenerative Therapy for ARDS Patients

Phase 2

Not yet recruiting

• Conditions: Acute Respiratory Distress Syndrome; Respiratory Failure; Respiratory Distress Syndrome; Respiratory Tract Diseases; Cytokine Storm

• Registration Number: NCT06308926
• Lead Sponsor: MedRegen LLC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-12-18
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Not yet recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Inclusion Criteria:<br><br>Acute Respiratory Distress Syndrome, manifested by the following and not explained by<br>alternative diagnoses, for example but not limited to: Pulmonary Edema due to Congestive<br>Heart Failure (CHF).<br><br> 1. Chest x-ray (CXR)* revealing bilateral infiltrates involving a minimum of three<br> quadrants on frontal chest radiograph, consistent with pulmonary edema or bilateral<br> ground glass opacities not fully explained by effusions, lobar or lung collapse,<br> nodules, atelectasis or other etiology of infiltrates not due to ARDS.<br><br> 2. PaO2/FiO2 < 300.<br><br> 3. Requiring respiratory support [defined as mechanical ventilation, non-invasive<br> ventilation (NIV) or high flow nasal canula (HFNC)] If on ventilator, settings must<br> include positive end-expiratory pressure (PEEP) or continuous positive airway<br> pressure (CPAP) =5 cm H2O.<br><br>Exclusion Criteria:<br><br> 1. Age less than 18 years.<br><br> 2. Infiltrates with etiology suspected of mimicking ARDS, ie; Pulmonary Edema due to<br> Congestive Heart Failure (CHF). (A Pulmonary Arterial Wedge Pressure (PAWP) of < 18<br> for >12 hours would rule out suspected CHF).<br><br> 3. Pregnancy documented or suspected in women of child bearing potential, unless ruled<br> out by a negative pregnancy test during screening or breast feeding.<br><br> 4. Immunocompromised patients:<br><br> 4.1. Organ or bone marrow transplant recipients and/or recent (within 2 months)<br> chronic use of immunosuppressive drugs (tacrolimus, mycofenolate mofetil,<br> cyclosporine, rapamycine, hydrochloroquine, azathiopurine, methotrexate), e.g.,<br> biologicals, JAK1/2 inhibitors, interferons, interleukins, (prednisone or related<br> corticosteroids are allowed).<br><br> 4.2. Patients with documented or suspected HIV/AIDS, hepatitis B/C or active lung<br> disease with tuberculosis. 4.3. Patients with active cancer diagnosis or use of<br> chemotherapy in the past 3 months.<br><br> 5. Hypersensitivity to either of the components of MRG-001.<br><br> 6. The patient is known or suspected to be brain dead or is moribund (not expected to<br> live >48 hours) or is unlikely to survive long enough to receive 3 injections (4<br> days) in the opinion of the investigator.<br><br> 7. The primary care physician is not committed to full support of the patient. (A DNR<br> representing no chest compression only, would not necessarily be an exclusion. A<br> DNR in which life support is withheld/withdrawn or is otherwise limited, would be an<br> exclusion).<br><br> 8. Participation in another investigational protocol or use of another investigational<br> drug within 30 days of enrollment.<br><br> 9. Enrollment time window has been exceeded (must be enrolled within 7 days of hospital<br> admission and within 48 hours of development of ARDS).<br><br> 10. Significant pre-existing organ dysfunction prior to randomization:<br><br> 10.1. Lung: Receiving supplemental home oxygen therapy at baseline for pre-existing<br> medical condition (other than COVID-19), as documented in medical record. 10.2.<br> Heart: Pre-existing congestive heart failure defined as an ejection fraction <20% as<br> documented in the medical record. Clinically significant ventricular arrhythmias<br> (ventricular tachycardia, ventricular fibrillation), unstable angina, myocardial<br> infarction (past 3 months), heart and coronary vessel surgery (past 3 months),<br> significant valvular heart disease, uncontrolled arterial hypertension with systolic<br> blood pressure >180 mm Hg and diastolic blood pressure >110 mm Hg. WHO Class III or<br> IV pulmonary hypertension. 10.3. Renal: End-stage renal disease requiring renal<br> replacement therapy or eGFR <30 mL/min. 10.4. Liver: Severe chronic liver disease<br> defined as Child-Pugh Class C or pre-existing severe hepatic dysfunction (i.e.;<br> portal hypertension, cirrhosis, ascites, esophageal variceal bleeding, acute hepatic<br> necrosis). 10.5. Hematologic: Baseline platelet count <30,000/mm3 or hemoglobin<br> levels <6.0 g/dL. 10.6. Neurological: Severe traumatic brain injury, with<br> intracranial injury demonstrated by head CT 10.7. History of splenectomy or<br> splenomegaly (spleen weighing > 750 g).<br><br> 11. Currently receiving extracorporeal life support (ECLS/ECMO) or high-frequency<br> oscillatory ventilation (HFOV).<br><br> 12. Anticipated extubation within 24 hours of enrollment.

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Hemopoietic stem cell mobilization;Organ Failure

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetics;Pharmacokinetics;Pharmacodynamics;Cytokine Changes;Respiratory-Free Days