Phase 2 Interstitial Lung Disease Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• You must be able to understand and agree to take part in the study by signing a consent form.
• You must be between 18 and 60 years old (inclusive) at the time you give consent.
• You must already qualify to be listed for a lung transplant under national transplant guidelines (UNOS criteria).
• You must have a serious, end-stage lung disease, such as Pulmonary Fibrosis or COPD/Emphysema (confirm with trial site for other conditions).
• You must have evidence that your bone marrow is not working well enough, shown by at least one of the following lasting over the past year: an unexplained low white blood cell count (neutrophils below 1,500/µL), an unexplained low platelet count (below 100,000/µL), or an unexplained low red blood cell level (hemoglobin below 12 g/dL) — all confirmed by repeat blood tests.
• Your kidneys must be working at a sufficient level (GFR of 45 or above) (confirm with trial site).
• Your liver function blood test results must be within acceptable ranges (confirm with trial site for specific values).
• Your heart must be pumping well enough, as shown by specific heart function measurements (confirm with trial site for exact thresholds).
• If you are female, you must have a negative pregnancy test, unless you have had a surgical procedure that means you cannot get pregnant.
• All women who could become pregnant and all sexually active men must agree to use an approved form of birth control for up to 24 months after the bone marrow transplant, or for as long as required by any medications involved.
• You will be given information and counselling about the possibility of infertility after the bone marrow transplant, and you will be advised to consider sperm banking or egg freezing before proceeding.

Who may not be able to join:

• You are not able or not willing to sign a consent form or follow the study requirements.
• You have been diagnosed with any type of cancer.
• Your condition does not require a bone marrow transplant as part of your treatment.
• You have tested positive for HIV or HTLV (a specific virus), confirmed by appropriate testing.
• You are currently pregnant or breastfeeding.
• You have an allergy to DMSO or any other ingredient used in making the stem cell treatment product.
• You have a lung infection that is not under control, based on scans or a significant worsening of your condition (note: having multiple organisms in the lungs without active infection does not automatically exclude you).
• You have any other serious infection that is not under control, confirmed by imaging or lab tests.
• You have received a live vaccine (licensed or experimental) within 4 weeks before the transplant.
• You have any other health problems, physical findings, or test results that the study doctor believes could put you at extra risk or affect the study results.

Important: Always verify eligibility with the trial site directly before applying.