Nebulized Human Amniotic Fluid in Patients With Interstitial Lung Disease

NCT07372989 | Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: 2025-MSCRI-001
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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

Lung Diseases, Interstitial

Keywords

Interstitial Lung Disease (ILD)

Outcome Measures

Primary Outcomes (1)

• Incidence of Treatment-Emergent Adverse Events

  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

  From first dose through study completion (approximately 13 months)

Secondary Outcomes (1)

• Change in observed forced vital capacity (FVC) .

  Baseline to 6 months.

Other Outcomes (1)

• Forced expiratory volume in 1 second (FEV1).

  Baseline to 6 months

Study Arms (2)

Cohort A

EXPERIMENTAL

1.0 mL of Matrix (Exosomes)

Biological: Matrix

Cohort B

EXPERIMENTAL

1.5 mL of Matrix (Exosomes)

Biological: Matrix

Interventions

Matrix BIOLOGICAL

Allogeneic Human Amniotic Fluid (HAF) using Aerogen Solo (Ultra Nebulizer)

Cohort A; Cohort B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Maule Stem Cell Research Institute, Inc.: lead

Study Sites (1)

Maule Stem Cell Research Institute

Venice, Florida, 34292, United States

RECRUITING

MeSH Terms

Conditions

Lung Diseases, Interstitial

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases

Study Officials

• Cynthia S. Maule, M.D.

  Maule Stem Cell Research Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kendra Hekter

CONTACT

941-949-2474; kendra@mauleresearch.org

Bonnie Vasquez

CONTACT

941-949-2474; bonnie@mauleresearch.org

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be placed into 2 Cohorts of 22 participants in each treatment arm: Cohort A: Doses 1.0 ml of Matrix 1×10\^9 particles via mesh nebulizer Cohort B: Doses 1.5 ml of Matrix 1×10\^12 particles via mesh nebulizer

Study Record Dates

• First Submitted: January 14, 2026
• First Posted: January 28, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): October 1, 2028
• Last Updated: January 29, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)