Nebulized Human Amniotic Fluid in Patients With Interstitial Lung Disease (HAF ILD)

January 27, 2026 updated by: Maule Stem Cell Research Institute, Inc.

A Phase 1, Study of Nebulized Matrix - Allogeneic Human Amniotic Fluid (HAF) In Patients With Interstitial Lung Disease: AIRMID Trial

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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 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

Enrollment (Estimated)

50

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Florida
      • Venice, Florida, United States, 34292
        • Recruiting
        • Maule Stem Cell Research Institute
        • Contact:
        • Contact:
        • Principal Investigator:
          • Cynthia S Maule, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 sterile or post-menopausal (>1 year).

Exclusion Criteria:

In order to participate in this study, a patient MUST NOT:

  • CT and/or surgical lung biopsy results inconsistent with the diagnosis of IPF.
  • Inability to perform any of the assessments required for endpoint analysis (report safety or tolerability concerns, perform PFTs or CT, undergo blood draws, read and respond to questionnaires.)
  • Currently receiving (or received within four weeks of screening) any medication, treatment, or experimental agents for the treatment of ILD, except for patients receiving non-drug therapies will include oxygen saturation therapy (oxygen supplementation) and pulmonary rehabilitation.
  • Active listing (or expected future listing) for transplant of any organ.
  • Clinically important abnormal screening laboratory values, including but not limited to: hemoglobin <8 g/dl, white blood cell count <3000/mm3, platelets <80,000/mm3, INR > 1.5, aspartate transaminase, alanine transaminase, or alkaline phosphatase > 2 times upper limit of normal, total bilirubin > 1.5 mg/dl.
  • Serious comorbid illness that, in the opinion of the investigator, may compromise the safety or compliance of the patient or preclude successful completion of the study. Including, but not limited to: HIV, advanced liver or renal failure, class III/IV congestive heart failure, myocardial infarction, unstable angina, or cardiac revascularization within the last six months, or severe obstructive ventilatory defect.
  • Any other condition that, in the opinion of the investigator, may compromise the safety or compliance of the patient or preclude successful completion of the study.
  • Be an organ transplant recipient.
  • Have a clinical history of malignancy within 2.5 years (i.e., patients with prior malignancy must be disease free for 2.5 years), except curatively treated basal cell carcinoma, squamous cell carcinoma, or cervical carcinoma.
  • Have a non-pulmonary condition that limits lifespan to < 1 year.
  • Have a history of drug or alcohol abuse within the past 24 months.
  • Be serum positive for HIV, hepatitis BsAg or Viremic hepatitis C.
  • Be currently participating (or participated within the previous 30 days) in an investigational therapeutic or device trial.
  • Be a female who is pregnant, nursing, or of childbearing potential while not practicing effective contraceptive methods. Female patients must undergo a blood or urine pregnancy test at screening and within 36 hours prior to injection.
  • Female subjects must have an FSH < 25.8 IU/L
  • Subject with hypersensitivity to dimethyl sulfoxide (DMSO)
  • Saturated oxygen (SpO2 of < 93% (room air [sea level] at rest). SpO2 of < 88% (room air [>5,000 feet above sea level (1524 meters) at rest).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cohort A
1.0 mL of Matrix (Exosomes)
Biological: Matrix
Allogeneic Human Amniotic Fluid (HAF) using Aerogen Solo (Ultra Nebulizer)
Experimental: Cohort B
1.5 mL of Matrix (Exosomes)
Biological: Matrix
Allogeneic Human Amniotic Fluid (HAF) using Aerogen Solo (Ultra Nebulizer)

What is the study measuring?

Primary Outcome Measures

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

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
From first dose through study completion (approximately 13 months)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in observed forced vital capacity (FVC) .
Time Frame: Baseline to 6 months.

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 (%)
Baseline to 6 months.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Forced expiratory volume in 1 second (FEV1).
Time Frame: Baseline to 6 months

Change From Baseline in Forced Expiratory Volume in 1 Second (FEV₁)

Outcome Measure Description:

Change from baseline in forced expiratory volume in 1 second (FEV₁) as assessed by pulmonary function testing.

Unit of Measure:

Liters (L) or percent predicted (%)
Baseline to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Maule Stem Cell Research Institute, Inc.

Investigators

  • Principal Investigator: Cynthia S. Maule, M.D., Maule Stem Cell Research Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 1, 2026

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

October 1, 2028

Study Registration Dates

First Submitted

January 14, 2026

First Submitted That Met QC Criteria

January 22, 2026

First Posted (Actual)

January 28, 2026

Study Record Updates

Last Update Posted (Actual)

January 29, 2026

Last Update Submitted That Met QC Criteria

January 27, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025-MSCRI-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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