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

NCT06308926 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2024-08-23

No results posted yet for this study

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.

Conditions

  • Acute Respiratory Distress Syndrome
  • Respiratory Failure
  • Respiratory Distress Syndrome
  • Respiratory Tract Diseases
  • Cytokine Storm

Interventions

DRUG

MRG-001 (Low-dose)

MRG-001 is subcutaneously administered.

DRUG

MRG-001 (High-dose)

MRG-001 is subcutaneously administered.

OTHER

Placebo

Saline placebo will be administered subcutaneously based on bodyweight and similar dose as the treatment group.

Sponsors & Collaborators

  • Vanderbilt University Medical Center

    collaborator OTHER

  • MedRegen LLC

    lead INDUSTRY

Principal Investigators

  • Gordon R Bernard, MD · Vanderbilt University Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-01
Primary Completion
2026-02-01
Completion
2026-07-01
FDA Drug
Yes

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06308926 on ClinicalTrials.gov