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NCT07372989 · ClinicalTrials.gov registry record · Phase 1

Nebulized Human Amniotic Fluid in Patients With Interstitial Lung Disease

A Phase 1 study of Lung Diseases, Interstitial, sponsored by Maule Stem Cell Research Institute.

Recruiting
Registry status
Phase 1
Development phase
50
Enrollment target
1
Study location

NCT07372989: Recruiting Phase 1 study of Lung Diseases, Interstitial, sponsored by Maule Stem Cell Research Institute.

NCT07372989 is a Phase 1 study of Lung Diseases, Interstitial that is actively recruiting participants, run by Maule Stem Cell Research Institute. The registered enrollment target is 50 participants, below the 12,504-participant average among 10 other Lung Diseases, Interstitial trials with a reported enrollment target (100% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT07372989, a Phase 1 study of Lung Diseases, Interstitial, is actively recruiting participants, sponsored by Maule Stem Cell Research Institute.

RECRUITING
Registry status
Phase 1
Development phase
50 participants
Enrollment target
1
Study location

Study 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.

Primary Outcome

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

Interventions

  • BIOLOGICAL Matrix

Study Locations (1)

Florida

  • Maule Stem Cell Research Institute - Venice

Trial Details

FieldValue
Enrollment Target 50 participants
Start Date 2026-02
Est. Completion 2028-10-01
Phase Phase 1

What NCT07372989 shows while recruiting

NCT07372989 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 12,504-participant average among 10 other Lung Diseases, Interstitial trials with a reported enrollment target (100% lower).

The record links to 1 condition, with Lung Diseases, Interstitial appearing as the primary indexed condition, and to 1 intervention - of which Matrix is the first listed.

NCT07372989 reports a single indexed study location in Florida.

Frequently Asked Questions

What is clinical trial NCT07372989 about?

NCT07372989 is a clinical study titled "Nebulized Human Amniotic Fluid in Patients With Interstitial Lung Disease". 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...

What is the current status of trial NCT07372989?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 50 participants. The study started on 2026-02. Estimated completion is 2028-10-01.

What conditions does trial NCT07372989 study?

This clinical trial studies the following conditions: Lung Diseases, Interstitial.

What interventions are being tested in trial NCT07372989?

The interventions under investigation include: Matrix (BIOLOGICAL).

Who is sponsoring clinical trial NCT07372989?

This trial is sponsored by Maule Stem Cell Research Institute, which has 1 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT07372989 being conducted?

This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Lung Diseases, Interstitial

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT07372989's enrollment target sits among peer trials

50 7th of 10 higher than 4 of 10 other Lung Diseases, Interstitial trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Lung Diseases, Interstitial trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT07372989, the US trial registry maintained by the National Library of Medicine. NCT07372989 (small enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.