Could amniotic fluid mist help heal scarred lungs?
NCT ID NCT07372989
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-stage study tests whether inhaling a mist made from donated human amniotic fluid is safe for people with interstitial lung disease (ILD), a condition that scars the lungs and makes breathing hard. About 50 adults aged 40 to 90 with mild to moderate ILD will receive the treatment. The goal is to check for side effects and see if lung function improves.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 50 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Feb 2026
An estimate. Start dates often move.
- Expected to finish
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Oct 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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).
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Maule Stem Cell Research Institute
RECRUITINGVenice, Florida, 34292, United States
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