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RECRUITING
NCT07372989
PHASE1

Nebulized Human Amniotic Fluid in Patients With Interstitial Lung Disease

Sponsor: Maule Stem Cell Research Institute, Inc.

View on ClinicalTrials.gov

Summary

This is a Phase I, pilot clinical trial designed to evaluate the safety and exploratory efficacy of nebulized diluted amniotic fluid, Matrix (HAF-Matrix) in adults with interstitial lung disease (ILD). ILDs are progressive fibrotic disorders characterized by aberrant wound-healing responses, chronic inflammation, and dysregulated fibroblast activation, ultimately leading to impaired gas exchange and respiratory failure. Current treatments, such as antifibrotic agents (pirfenidone and nintedanib), slow disease progression but do not reverse existing fibrosis or restore lung function. This pilot study will generate critical safety and preliminary efficacy data to inform future larger-scale trials and optimize dosing strategies for nebulized HAF-based therapeutics in ILD.

Official title: A Phase 1, Study of Nebulized Matrix - Allogeneic Human Amniotic Fluid (HAF) In Patients With Interstitial Lung Disease: AIRMID Trial

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

50

Start Date

2026-02

Completion Date

2028-10-01

Last Updated

2026-01-29

Healthy Volunteers

No

Interventions

BIOLOGICAL

Matrix

Allogeneic Human Amniotic Fluid (HAF) using Aerogen Solo (Ultra Nebulizer)

Locations (1)

Maule Stem Cell Research Institute

Venice, Florida, United States