Nebulized Human Amniotic Fluid in Patients With Interstitial Lung Disease

Part of paid clinical trials in Venice, Florida.

Sponsor
Maule Stem Cell Research Institute, Inc.
Study ID
NCT07372989
Phase
PHASE1
Status
Recruiting
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Conditions

  • Lung Diseases, Interstitial

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Matrix — BIOLOGICAL
    Allogeneic Human Amniotic Fluid (HAF) using Aerogen Solo (Ultra Nebulizer)

Study Details

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.

Key Dates

Start date
Feb 28, 2026
Status verified
Jan 2026
Primary completion
Jun 1, 2027
Completion
Oct 1, 2028

Study Design

Enrollment
50 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort A
    1.0 mL of Matrix (Exosomes)
  • Experimental: Cohort B
    1.5 mL of Matrix (Exosomes)

Primary Outcome Measure

Incidence of Treatment-Emergent Adverse Events [ Time Frame: From first dose through study completion (approximately 13 months) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Maule Stem Cell Research InstituteVeniceFlorida34292
Cynthia S. Maule, M.D.
[email protected]
941-949-2474
Bonnie Vasquez
[email protected]
941-949-2474
Cynthia S Maule, M.D. (PRINCIPAL_INVESTIGATOR)

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