Nebulized Human Amniotic Fluid for Interstitial Lung Disease

(HAF ILD Trial)

This trial tests a new treatment using nebulized human amniotic fluid, called Matrix, to determine its safety and effectiveness for adults with interstitial lung disease (ILD). ILD is a lung condition where tissue becomes thick and scarred, making breathing difficult. The study includes two groups, each receiving a different dose to identify the optimal amount. It seeks participants diagnosed with ILD who have stable breathing and require minimal oxygen support. The goal is to determine if this treatment can safely improve lung function in those affected by ILD. As a Phase 1 trial, this research aims to understand how the treatment works in people, offering participants the chance to be among the first to receive this innovative therapy.

The trial requires that you stop taking any medication, treatment, or experimental agents for ILD within four weeks of screening, except for non-drug therapies like oxygen supplementation and pulmonary rehabilitation.

Research has shown that human amniotic fluid, used in treatments like the Matrix, is still under study to ensure safety. In one study involving many patients using amniotic-derived exosomes, some participants tolerated the treatment well, but detailed safety information remains limited.

Researchers are excited about using nebulized human amniotic fluid for interstitial lung disease because it utilizes a novel approach involving exosomes, which are tiny particles that can facilitate cell communication and repair. Unlike traditional treatments that often focus on reducing inflammation or suppressing the immune system, these exosomes might help regenerate lung tissue, potentially offering a new mechanism of healing. Additionally, the delivery method via nebulization allows for direct application to the lungs, which could enhance the treatment's effectiveness and reduce systemic side effects. This innovative approach could transform how we manage and treat interstitial lung disease.

Research shows that human amniotic fluid, particularly the exosomes it contains, might help treat lung diseases. These exosomes can reduce inflammation and aid in lung tissue repair. Studies on exosomes from certain stem cells suggest they lessen lung damage by delivering beneficial substances to injured areas. Although direct evidence for treating interstitial lung disease is still developing, these early results are promising. In this trial, participants will receive different dosages of Matrix (Exosomes) in separate treatment arms: Cohort A will receive 1.0 mL, and Cohort B will receive 1.5 mL. The treatment aims to improve lung function and slow the disease by addressing inflammation and tissue damage.¹²⁴⁶⁷