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.
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.)
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
50
Allogeneic Human Amniotic Fluid (HAF) using Aerogen Solo (Ultra Nebulizer)
Maule Stem Cell Research Institute
Venice, Florida, United States
RECRUITINGIncidence 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
Time frame: From first dose through study completion (approximately 13 months)
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 (%)
Time frame: Baseline to 6 months.
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