A Phase 1, Study of Nebulized Matrix - Allogeneic Human Amniotic Fluid (HAF) In Patients With Interstitial Lung Disease: AIRMID Trial
Maule Stem Cell Research Institute, Inc.
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.
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 interva…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 steri…
Interventions
- BiologicalMatrix
Allogeneic Human Amniotic Fluid (HAF) using Aerogen Solo (Ultra Nebulizer)
Location
- Maule Stem Cell Research InstituteVenice, Florida