Nebulized human amniotic fluid for interstitial lung disease

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

This pilot will try nebulized diluted human amniotic fluid (HAF‑Matrix) in adults 40–90 with interstitial lung disease to check safety and look for early signs of benefit.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 50 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Maule Stem Cell Research Institute, Inc. (Academic / other)
• Locations: 1 site (Venice, Florida)
• Trial ID: NCT07372989 on ClinicalTrials.gov

What this trial studies

This Phase I pilot uses a two-part design: a 3+3 staggered dose‑escalation run‑in followed by an open‑label phase with two cohorts of 22 participants each. Participants receive HAF‑Matrix by mesh nebulizer at two dose volumes (1.0 ml and 1.5 ml) with targeted particle loads (1×10^9 and 1×10^12 particles). The primary focus is safety and tolerability with exploratory efficacy measures such as pulmonary function tests and imaging to capture preliminary signals. The single‑center trial is sponsored by Maule Stem Cell Research Institute and targets adults with guideline‑defined ILD and preserved enough lung function to meet enrollment thresholds.

Who should consider this trial

Good fit: Adults aged 40–90 with a guideline‑supported diagnosis of ILD, FVC ≥45% predicted, DLCO ≥30% corrected for hemoglobin, resting SpO₂ ≥92% on ≤3 L/min O₂, RVSP <50 mmHg, and women who are postmenopausal or surgically sterile.

Not a fit: Patients with CT or surgical biopsy results inconsistent with IPF (per protocol), those with lung function below the study cutoffs or very advanced disease, or individuals unable to complete required testing or travel for dosing are unlikely to benefit from or qualify for this pilot.

Why it matters

Potential benefit: If successful, nebulized HAF‑Matrix could offer a novel inhaled therapy that is safe and may slow fibrosis progression and help preserve lung function in people with ILD.

How similar studies have performed: Inhaled extracellular vesicle and amniotic‑fluid–derived therapies are early‑stage in humans with limited safety data and no established efficacy for ILD to date.

Eligibility criteria

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).

Where this trial is running

Venice, Florida

• Maule Stem Cell Research Institute — Venice, Florida, United States (Recruiting)

Study contacts

• Principal investigator: Cynthia S. Maule, M.D. — Maule Stem Cell Research Institute
• Study coordinator: Kendra Hekter

Conditions Lung Diseases, Interstitial; Interstitial Lung Disease