Nebulized Human Amniotic Fluid for Interstitial Lung Disease

(HAF ILD Trial)

Overseen By Bonnie Vasquez

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Maule Stem Cell Research Institute, Inc.

Must not be taking: Antifibrotic agents

Disqualifiers: Organ transplant, HIV, advanced liver failure, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

Cynthia S. Maule, M.D.

Principal Investigator

Maule Stem Cell Research Institute

Are You a Good Fit for This Trial?

This clinical trial is for adults with interstitial lung disease (ILD), a condition where scar tissue forms in the lungs, making it hard to breathe. Participants should be interested in trying a new treatment that isn't widely available yet.

Inclusion Criteria

Have a clinical diagnosis of ILD prior to screening in accordance with the guidelines of the American Thoracic Society/European Respiratory Society

Provide written informed consent

FVC ≥ 45% predicted and DLCO ≥30% (corrected for hemoglobin but not alveolar volume)

Exclusion Criteria

CT and/or surgical lung biopsy results inconsistent with the diagnosis of IPF

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

I have been cancer-free for 2.5 years, except for certain skin or cervical cancers.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Initial dosing with a 3+3 cohort design to monitor early safety signals

Approximately 1 month

Multiple visits for dosing and monitoring

Treatment

Participants receive nebulized Matrix (HAF) therapy in two cohorts with different doses

6 months

Regular visits for dosing and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

7 months

What Are the Treatments Tested in This Trial?

Interventions

• Matrix

Trial Overview

The trial is testing 'Matrix,' which is nebulized human amniotic fluid. It's given as a mist you breathe in and aims to see if it can help people with ILD by improving lung function or slowing down the disease.

How Is the Trial Designed?

Group I: Cohort B Experimental Treatment 1 Intervention

1.5 mL of Matrix (Exosomes)

Group II: Cohort A Experimental Treatment 1 Intervention

1.0 mL of Matrix (Exosomes)

Who Is Running the Clinical Trial?

Maule Stem Cell Research Institute, Inc.

Lead Sponsor