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Nebulized Human Amniotic Fluid for Interstitial Lung Disease

This study is testing a treatment called nebulized Human Amniotic Fluid (HAF) using an Aerogen Solo device for people with Interstitial Lung Disease (ILD). ILD is a group of lung conditions where the lungs become scarred, making it hard to breathe. Current treatments can slow the disease but don't reverse the scarring. This study aims to see if nebulized HAF is safe and if it might help improve lung function. You might be able to join if you are between 40 and 90 years old and have a diagnosis of ILD. The study is currently unclear on its recruitment status and plans to enroll 50 participants. The main goal is to track any side effects from the treatment.

Study design
This is a Phase I pilot study, meaning it's an early-stage trial to check safety and initial effectiveness. It will involve 50 participants, starting with a small group to test different doses, followed by two larger groups.
What's involved
To participate, you must provide written informed consent. The study will involve receiving doses of Matrix (HAF) via a nebulizer.
Compensation
Not stated in the trial record.
Follow-up
Your safety will be monitored from your first dose through the end of the study, which is about 13 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07372989

Nebulized Human Amniotic Fluid in Patients With Interstitial Lung Disease

Recruiting
PHASE1Ages 18+InterventionalTreatment
Maule Stem Cell Research Institute, Inc.
~50 participants
Updated 2026-01-29 on ClinicalTrials.gov
What's tested:Matrix

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of Treatment-Emergent Adverse Events
Measured over From first dose through study completion (approximately 13 months)

Conditions

Lung Diseases, Interstitial

Explore related trials

Interstitial Lung Disease

Where it's being run

1 sites across 1 states
Florida1

Study leadership

  • Cynthia S. Maule, M.D. · PRINCIPAL_INVESTIGATOR · Maule Stem Cell Research Institute

Who to contact

Kendra Hekter
[email protected]
941-949-2474
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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).

What this trial measures

  • Incidence of Treatment-Emergent Adverse EventsFrom 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