Phase 1RecruitingAge-related condition
Nebulized Human Amniotic Fluid in Patients With Interstitial Lung Disease (HAF ILD)
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. (Academic or other)
- Enrollment
- 50 planned
- Conditions
- Lung Diseases, Interstitial
- Interventions
- Matrix
- Ages
- adults, older adults
- Registry
- NCT07372989
Full record on ClinicalTrials.gov
From the registry
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.
Primary outcomes
- Incidence of Treatment-Emergent Adverse Events
History
Study completion expected
Primary completion expected
Last registry update
Started
Registered