Lung Diseases, InterstitialPhase 1HAF ILDNCT07372989
Nebulized Human Amniotic Fluid in Patients With Interstitial Lung Disease
A Phase 1 study testing Matrix in people with Lung Diseases, Interstitial, run by Maule Stem Cell Research Institute, Inc. at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Diseases, Interstitial
- What is being tested?
- Matrix
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Feb 2026to Oct 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
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- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Maule Stem Cell Research Institute
Venice, Florida, 34292
Cynthia S. Maule, M.D., 941-949-2474, drmaule@mauleresearch.org
Bonnie Vasquez, 941-949-2474, bonnie@mauleresearch.org
About this study
Official title: A Phase 1, Study of Nebulized Matrix - Allogeneic Human Amniotic Fluid (HAF) In Patients With Interstitial Lung Disease: AIRMID 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.
Read the detailed description
This pilot study will generate critical safety and preliminary efficacy data to inform future larger-scale trials and optimize dosing strategies for nebulized EV-based therapeutics in ILD.
Two-part seamless design:
Dose Escalation Approach with a 3+3 (Cohort A = 3, Cohort B = 3) Total of 6 Participants Design with Staggered Dosing:
- Cohort Enrollment and Initial Dosing
- At each prespecified dose level, three (3) subjects will be enrolled and dosed.
The first subject in each cohort will be dosed initially, followed by the second and third subjects according to planned staggered intervals, ensuring careful monitoring of early safety signals.
Post 3x3 run-in phase, The Phase 1(open label) will begin:
- 2 Cohorts of 22 participants per cohort:
- Doses 1.0 ml and 1.5 ml of Matrix via mesh nebulizer:
Cohort A, n=22: 1×10^9 particles Cohort B, n=22: 1×10^12 particles (Dose range anchored to inhaled-EV clinical experience.)
- Conditions
- Lung Diseases, Interstitial
- Being tested
- Matrix
- Keywords
- Interstitial Lung Disease (ILD)
- Medical subject headings
- Lung Diseases, Interstitial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MatrixBiological
Allogeneic Human Amniotic Fluid (HAF) using Aerogen Solo (Ultra Nebulizer)
| Study group | Role | What they receive |
|---|---|---|
| Cohort A | Experimental | 1.0 mL of Matrix (Exosomes) Receives: Biological: Matrix |
| Cohort B | Experimental | 1.5 mL of Matrix (Exosomes) Receives: Biological: Matrix |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: From first dose through study completion (approximately 13 months)
Secondary outcomes (1)
Change in observed forced vital capacity (FVC) .
Change From Baseline in Forced Vital Capacity (FVC)
Outcome Measure Description:
Change from baseline in forced vital capacity (FVC) as assessed by pulmonary function testing.
Unit of Measure:
Liters (L) or percent predicted (%)
Measured: Baseline to 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2026
- Study start23 Feb 2026
- Primary completionJun 2028 (estimated)
- Study completionOct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung Diseases, InterstitialStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 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
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maule Stem Cell Research Institute, Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cynthia S. Maule, M.D., Principal investigator, Maule Stem Cell Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07372989
- Sponsor's protocol ID
- 2025-MSCRI-001
- Acronym
- HAF ILD
- Status last verified
- Oct 2026
- First submitted
- 14 Jan 2026
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Study of Nebulized Matrix - Allogeneic Human Amniotic Fluid (HAF) In Patients With Interstitial Lung Disease: AIRMID Trial
- ClinicalTrials.gov ID
- NCT07372989
- Acronym / sponsor ID
- HAF ILD / 2025-MSCRI-001
- Conditions
- Lung Diseases, Interstitial
- Keywords
- Interstitial Lung Disease (ILD)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Maule Stem Cell Research Institute, Inc.University, hospital or other
- Study start
- 23 Feb 2026 (actual)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Oct 2028 (estimated)
- First posted
- 28 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This pilot study will generate critical safety and preliminary efficacy data to inform future larger-scale trials and optimize dosing strategies for nebulized EV-based therapeutics in ILD.
Two-part seamless design:
Dose Escalation Approach with a 3+3 (Cohort A = 3, Cohort B = 3) Total of 6 Participants Design with Staggered Dosing:
- Cohort Enrollment and Initial Dosing
- At each prespecified dose level, three (3) subjects will be enrolled and dosed.
The first subject in each cohort will be dosed initially, followed by the second and third subjects according to planned staggered intervals, ensuring careful monitoring of early safety signals.
Post 3x3 run-in phase, The Phase 1(open label) will begin:
- 2 Cohorts of 22 participants per cohort:
- Doses 1.0 ml and 1.5 ml of Matrix via mesh nebulizer:
Cohort A, n=22: 1×10^9 particles Cohort B, n=22: 1×10^12 particles (Dose range anchored to inhaled-EV clinical experience.)
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| Cohort A | Experimental | Biological: Matrix1.0 mL of Matrix (Exosomes) |
| Cohort B | Experimental | Biological: Matrix1.5 mL of Matrix (Exosomes) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (18 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MatrixAllogeneic Human Amniotic Fluid (HAF) using Aerogen Solo (Ultra Nebulizer) | Biological | Cohort A, Cohort B |
Primary outcome
Incidence of Treatment-Emergent Adverse Events
Time frame: From first dose through study completion (approximately 13 months)
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
1 secondary outcome
Change in observed forced vital capacity (FVC) .
Time frame: Baseline to 6 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Cynthia S. Maule, M.D. principal investigator
Maule Stem Cell Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Matrix in people with Lung Diseases, Interstitial, run by Maule Stem Cell Research Institute, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kendra Hekter (941-949-2474, kendra@mauleresearch.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Treatment-Emergent Adverse Events (time frame: From first dose through study completion (approximately 13 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.