NCT07372989

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Maule Stem Cell Research Institute, Inc. · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This pilot study will generate critical safety and preliminary efficacy data to inform future larger-scale trials and optimize dosing strategies for nebulized EV-based therapeutics in ILD. Two-part seamless design: Dose Escalation Approach with a 3+3 (Cohort A = 3, Cohort B = 3) Total of 6 Participants Design with Staggered Dosing: 1\. Cohort Enrollment and Initial Dosing • At each prespecified dose level, three (3) subjects will be enrolled and dosed. The first subject in each cohort will be dosed initially, followed by the second and third subjects according to planned staggered intervals, ensuring careful monitoring of early safety signals. Post 3x3 run-in phase, The Phase 1(open label) will begin: * 2 Cohorts of 22 participants per cohort: * Doses 1.0 ml and 1.5 ml of Matrix via mesh nebulizer: Cohort A, n=22: 1×10\^9 particles Cohort B, n=22: 1×10\^12 particles (Dose range anchored to inhaled-EV clinical experience.)

Conditions

• Lung Diseases, Interstitial

Interventions

Type	Name	Description
BIOLOGICAL	Matrix	Allogeneic Human Amniotic Fluid (HAF) using Aerogen Solo (Ultra Nebulizer)

Timeline

• Start date: 2026-02-01
• Primary completion: 2027-06-01
• Completion: 2028-10-01
• First posted: 2026-01-28
• Last updated: 2026-01-29

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study