RecruitingPhase 1NCT07372989

Nebulized Human Amniotic Fluid in Patients With Interstitial Lung Disease

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


Sponsor

Maule Stem Cell Research Institute, Inc.

Enrollment

50 participants

Start Date

Feb 1, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a biological treatment called Matrix for people with lung diseases, interstitial. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALMatrix

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


Locations(1)

Maule Stem Cell Research Institute

Venice, Florida, United States

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NCT07372989


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