Nebulized Human Amniotic Fluid in Patients With Interstitial Lung Disease
Trial Parameters
Brief 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 Criteria
Inclusion Criteria: In order to participate in this study, a patient MUST: * Provide written informed consent. * Subjects age \> 40 and \< 90 years at the time of signing the Informed Consent Form. * Have a clinical diagnosis of ILD prior to screening in accordance with the guidelines of the American Thoracic Society/European Respiratory Society. * FVC ≥ 45% predicted and DLCO ≥30% (corrected for hemoglobin but not alveolar volume). * Resting SpO₂ ≥ 92% on ≤ 3 L/min O₂. * RVSP \< 50 mmHg, as documented by Doppler echo or right heart catheterization. * Female subjects must be surgically sterile or post-menopausal (\>1 year). Exclusion Criteria: In order to participate in this study, a patient MUST NOT: * CT and/or surgical lung biopsy results inconsistent with the diagnosis of IPF. * Inability to perform any of the assessments required for endpoint analysis (report safety or tolerability concerns, perform PFTs or CT, undergo blood draws, read and respond to questionnaires.) * Currently