Nebulized human amniotic fluid for interstitial lung disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: kendra@mauleresearch.org
• Phone: 941-949-2474

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• TX000045 for pulmonary hypertension from interstitial lung disease

  This study tests TX000045 to see if it can reduce pulmonary vascular resistance in people with PH caused by interstitial lung disease and to check its safety.

  Recruiting at 12 sites Phase 2 Tectonic Operating Company, Inc. · Phoenix, Arizona and 15 other locations · NCT07473700

• Evaluating Belimumab for Lung Disease Linked to Autoimmune Conditions

  This study is testing if the medication belimumab can help adults with lung disease caused by autoimmune conditions feel better and breathe easier.

  Recruiting at 126 sites Phase 3 GlaxoSmithKline · Los Angeles, California and 131 other locations · NCT06572384

• Evaluating Olokizumab for Progressive Fibrosing Lung Diseases

  This study is testing if a new injection called olokizumab can help people with progressive fibrosing lung diseases breathe better and improve their overall health compared to a placebo.

  Recruiting at 33 sites Phase 2/3 R-Pharm · Barnaul and 32 other locations · NCT06440746

• Testing hymecromone in adults with interstitial lung disease

  This study is testing a new medication called hymecromone to see if it can help adults with progressive interstitial lung disease feel better and improve their lung function.

  Recruiting Phase 2 National Institutes of Health Clinical Center (CC) · Research Triangle Park, North Carolina · NCT06325696

• Digital self-management package for people with interstitial lung disease

  This study is testing a new smartphone app designed to help people with interstitial lung disease manage their health better and feel improved overall compared to standard care.

  Recruiting at 4 sites University of Sydney · Sydney, New South Wales and 3 other locations · NCT06122233

• Using cough samples to analyze lung health

  This study is testing whether cough samples can help us find signs of lung diseases by comparing them to samples taken from healthy people and smokers.

  Recruiting Albert Einstein College of Medicine · The Bronx, New York · NCT05854563

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.