Is NCT07372989 recruiting in Venice, FL?

Yes, NCT07372989 is currently recruiting participants at its Venice, FL location. This lung diseases, interstitial clinical trial is actively enrolling qualified participants.

How do I join the lung diseases, interstitial clinical trial in Venice?

To join this clinical trial in Venice, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Venice clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Lung Diseases, Interstitial Clinical Trial in Venice, FL

About This Lung Diseases, Interstitial Study in Venice

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.

Sponsor: Maule Stem Cell Research Institute, Inc.

Who Can Participate

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).

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Venice?

Yes, this clinical trial (NCT07372989) has an active research site in Venice, FL that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Lung Diseases, Interstitial Treatment Options in Venice, FL

If you're searching for lung diseases, interstitial treatment options in Venice, FL, this clinical trial (NCT07372989) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Venice research site is actively enrolling participants for this phase 1 clinical trial. You'll receive care from experienced lung diseases, interstitial specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all lung diseases, interstitial clinical trials near you to find additional studies recruiting in your area.

Lung Diseases, Interstitial Clinical Trial in Venice, FL

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