Is NCT05761899 recruiting in Cincinnati, OH?

Yes, NCT05761899 is currently recruiting participants at its Cincinnati, OH location. This hereditary pulmonary alveolar proteinosis clinical trial is actively enrolling qualified participants.

Is participation in this Cincinnati 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.

Hereditary Pulmonary Alveolar Proteinosis Clinical Trial in Cincinnati, OH

Q: How do I join the hereditary pulmonary alveolar proteinosis clinical trial in Cincinnati?

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

About This Hereditary Pulmonary Alveolar Proteinosis Study in Cincinnati

The major goal of this study is to evaluate a new type of cell transplantation therapy for individuals with hereditary PAP, study a new treatment that may be useful for treatment of other diseases, and research mechanisms that drive the development and function of lung macrophages.

Sponsor: Children's Hospital Medical Center, Cincinnati

Who Can Participate

Inclusion Criteria

Patients must meet all of the following conditions to be eligible for participation in this study:

Male or female with a confirmed diagnosis of hPAP defined as:

Homozygous or compound heterozygous CSF2RA mutations - AND -

A normal GM-CSF autoantibody test result - AND -

An abnormal STAT5-PI test result - OR -

An abnormal GM-CSF 50% effective concentration (EC50) test result

Diffuse ground glass opacification of the lungs visualized on a chest computed tomogram (CT)

History of prior receipt of WLL therapy or moderate hPAP lung disease severity requiring therapy in the opinion of the Clinical Site Investigator and/or Sponsor

Able to undergo bone marrow collection by routine clinical aspiration

18 years of age or older on the date the Informed consent form (ICF) is signed

Females who have been post-menopausal for \>2 years or females of child-bearing potential after a confirmed menstrual period using a highly efficient method of contraception (as described in Section 11.4.2) for the period from 3 months prior to the first administration of gene-corrected macrophages until 12 months after the last administration of gene-corrected macrophages. Females of child-bearing potential must have a negative serum pregnancy test at Screening (Visit 1), at bone marrow collection (Visit 2), and immediately before each administration of gene-corrected macrophages (Visits 3, 5, 7), and must not be lactating.

Males of reproductive potential must agree to use condoms for the period from the 1st administration of gene-corrected macrophages until 12 months after the last dose of gene-corrected macrophages, have a partner who is not of child-bearing potential (i.e. men or females who have been post-menopausal for \>2 years), or have a female partner who is using adequate contraception as described in Section 11.4.2.

Signed written informed consent form (ICF)

Exclusion Criteria

Patients who meet any of the following conditions will not be eligible for participation in this study:

History of a confirmed diagnosis of any other PAP-causing disease defined as:

PAP caused by function-altering mutations in CSF2RB, adenosine triphosphate (ATP)-binding cassette subfamily A member 3 (ABCA3), SFTPB, SFTPC, Thyroid Transcription Factor 1 (TTF-1), GATA-binding factor 2 (GATA2), SLC7A7, and methionyl-transfer RNA (tRNA) synthetase (MARS), or other genes demonstrated to cause PAP other than CSF2RA

PAP associated with an abnormal GM-CSF autoantibody test

PAP associated with hematologic disorders including but not limited to myelodysplasia, aplastic anemia, leukemia, multiple myeloma, lymphoma

PAP associated with non-hematologic malignancies

PAP associated with immune deficiency syndromes

PAP associated with chronic inflammatory syndromes

PAP associated with chronic infections including but not limited to human immunodeficiency virus, Mycobacteria tuberculosis or other Mycobacterial species, or other organisms

PAP associated with inhaled materials including but not limited to inorganic dusts (e.g., silica, titanium, indium, aluminum), organic dusts (e.g., sawdust, fertilizer); or gases/vapors (e.g., cleaning products, paints, and welding-related fumes)

Pulmonary fibrosis that is clinically significant in the opinion of Clinical Site Investigator and/or Sponsor

A confirmed (i.e., repeated) positive serum anti-GM-CSF receptor antibody test and/or a confirmed positive anti-lentiviral antibody test at the time of screening and prior to each administration of gene-corrected macrophages

History of receipt of any investigational agent within 3 months of Study Visit 3

History of active chronic infection (e.g., HIV, Hepatitis, others) at the time of Screening

History of significant alcohol consumption for a period of more than 3 consecutive months within 1 year prior to Study Visit 3, defined as more than 14 drinks/week for females or 21 drinks/week for males (1 drink - 5 ounces (150 ml) of wine or 12 ounces (360 ml) of beer, or 1.5 ounces (45 ml) of hard liquor)

History of medication or illicit drug abuse within 1 year prior to Study Visit 3, including but not limited to cocaine, heroin, or other opioids

Currently or planning to become pregnant between the Screening visit and Visit 14 and/or currently breast-feeding

Any other medical, behavioral, or psychiatric condition that would interfere with the completion of Study Visits or assessments in the opinion of the Clinical Site Investigator and/or Sponsor

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 Cincinnati?

Yes, this clinical trial (NCT05761899) has an active research site in Cincinnati, OH 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.

Hereditary Pulmonary Alveolar Proteinosis Treatment Options in Cincinnati, OH

If you're searching for hereditary pulmonary alveolar proteinosis treatment options in Cincinnati, OH, this clinical trial (NCT05761899) 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 Cincinnati research site is actively enrolling participants for this phase 1/2 clinical trial. You'll receive care from experienced hereditary pulmonary alveolar proteinosis 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 hereditary pulmonary alveolar proteinosis clinical trials near you to find additional studies recruiting in your area.

Hereditary Pulmonary Alveolar Proteinosis Clinical Trial in Cincinnati, OH

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