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.
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).
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 receiving (or received within four weeks of screening) any medication, treatment, or experimental agents for the treatment of ILD, except for patients receiving non-drug therapies will include oxygen saturation therapy (oxygen supplementation) and pulmonary rehabilitation.
Active listing (or expected future listing) for transplant of any organ.
Parallel
Matrix
Biological/VaccineAllogeneic Human Amniotic Fluid (HAF) using Aerogen Solo (Ultra Nebulizer)
Incidence of Treatment-Emergent Adverse Events
Outcome Measure Description: Incidence of treatment-emergent serious adverse events (TE-SAEs) in participants receiving nebulized Matrix (HAF) therapy. Unit of Measure: Number of participants with ≥1 TESAE
Change in observed forced vital capacity (FVC) .
Change From Baseline in Forced Vital Capacity (FVC) Outcome Measure Description: Change from baseline in forced vital capacity (FVC) as assessed by pulmonary function testing. Unit of Measure: Liters (L) or percent predicted (%)
Forced expiratory volume in 1 second (FEV1).
Change From Baseline in Forced Expiratory Volume in 1 Second (FEV₁) Outcome Measure Description: Change from baseline in forced expiratory volume in 1 second (FEV₁) as assessed by pulmonary function testing. Unit of Measure: Liters (L) or percent predicted (%)
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