Not Yet RecruitingPhase 2

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

60 participantsStarted 2024-12-01

Plain-language summary

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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. 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.

Exclusion criteria

✕. 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.
✕. Immunocompromised patients:
✕.1. Organ or bone marrow transplant recipients and/or recent (within 2 months) chronic use of immunosuppressive drugs (tacrolimus, mycofenolate mofetil, cyclosporine, rapamycine, hydrochloroquine, azathiopurine, methotrexate), e.g., biologicals, JAK1/2 inhibitors, interferons, interleukins, (prednisone or related corticosteroids are allowed).
✕.2. Patients with documented or suspected HIV/AIDS, hepatitis B/C or active lung disease with tuberculosis. 4.3. Patients with active cancer diagnosis or use of chemotherapy in the past 3 months.
✕. Hypersensitivity to either of the components of MRG-001.
✕. The patient is known or suspected to be brain dead or is moribund (not expected to live \>48 hours) or is unlikely to survive long enough to receive 3 injections (4 days) in the opinion of the investigator.

What they're measuring

Hemopoietic stem cell mobilization

Timeframe: 24 Hours

Organ Failure

Timeframe: 28 Days

Trial details

NCT IDNCT06308926

SponsorMedRegen LLC

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-02-01

Contact for this trial

MedRegen LLC

4437598563 info@medregenco.com

View on ClinicalTrials.gov More Acute Respiratory Distress Syndrome trials