Actively Recruiting
Nebulized Human Amniotic Fluid in Patients With Interstitial Lung Disease
Led by Maule Stem Cell Research Institute, Inc. · Updated on 2026-01-29
50
Participants Needed
1
Research Sites
139 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Nebulized Human Amniotic Fluid in Patients With Interstitial Lung Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provide written informed consent.
- Be aged over 40 and under 90 years at the time of consent.
- Have a clinical diagnosis of interstitial lung disease according to American Thoracic Society/European Respiratory Society guidelines.
- Have forced vital capacity (FVC) of at least 45% predicted and diffusing capacity of the lungs for carbon monoxide (DLCO) of at least 30% (corrected for hemoglobin).
- Have resting oxygen saturation (SpO2) of at least 92% on 3 liters per minute or less of oxygen.
- Have right ventricular systolic pressure (RVSP) less than 50 mmHg documented by Doppler echocardiography or right heart catheterization.
- Female participants must be surgically sterile or post-menopausal for more than 1 year.
You will not qualify if you...
- CT or surgical lung biopsy results inconsistent with idiopathic pulmonary fibrosis diagnosis.
- Unable to perform required assessments such as safety reporting, pulmonary function tests, CT scans, blood draws, or questionnaires.
- Receiving or received any medication, treatment, or experimental agents for ILD within 4 weeks before screening, except oxygen therapy or pulmonary rehabilitation.
- Active or expected listing for organ transplant.
- Abnormal screening lab values including hemoglobin less than 8 g/dl, white blood cell count less than 3000/mm3, platelets less than 80,000/mm3, INR over 1.5, liver enzymes over twice normal limits, or total bilirubin over 1.5 mg/dl.
- Serious comorbid illnesses such as HIV, advanced liver or kidney failure, severe heart failure, recent heart attack or unstable angina, or severe obstructive lung disease.
- Any condition that may compromise safety or study completion as judged by the investigator.
- History of organ transplant.
- History of malignancy within 2.5 years except certain skin or cervical cancers treated curatively.
- Non-pulmonary condition limiting lifespan to less than 1 year.
- History of drug or alcohol abuse within past 24 months.
- Positive for HIV, hepatitis B surface antigen, or active hepatitis C infection.
- Participation in another investigational trial within 30 days.
- Female who is pregnant, nursing, or of childbearing potential without effective contraception and requiring pregnancy testing.
- Female with follicle-stimulating hormone (FSH) below 25.8 IU/L.
- Hypersensitivity to dimethyl sulfoxide (DMSO).
- Resting oxygen saturation less than 93% at sea level or less than 88% at altitudes above 5,000 feet on room air.
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Maule Stem Cell Research Institute
Venice, Florida, United States, 34292
Actively Recruiting
Research Team
K
Kendra Hekter
CONTACT
B
Bonnie Vasquez
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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