Phase 2 Crohn's Disease and Colitis 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 are willing and able to sign a consent form to take part in the study.
• You have been diagnosed with Crohn's disease for at least 6 months, confirmed through medical tests such as scans, scopes, or biopsies.
• You previously took part in, or were treated as part of, a study called ADICROHN 2.
• Your Crohn's disease is currently not active or only mildly active, based on a standard scoring system used by doctors.
• You still have one or more fistulas (abnormal tunnels near the anus/perineum area) that did not heal during the ADICROHN-2 study, and they are still present now.
• OR your fistulas did heal during the ADICROHN-2 study, but they have come back by the time you would enroll in this trial.
• Enough of your cells were saved and stored from the previous study to be used in this new treatment, depending on how many fistulas need to be treated.
• You are 18 years of age or older.
• You are in generally good health based on your medical history and a physical check-up.
• If you are a woman who could become pregnant, you have a negative pregnancy test, and all participants (men and women) must use a reliable form of contraception during the trial.
• You are enrolled in a social security (health coverage) program.

Who may not be able to join:

• Your Crohn's disease is currently very active in the gut and needs immediate treatment.
• You had a bad reaction or could not tolerate the treatment given during the ADICROHN-2 study.
• You currently have an abscess (pocket of infection) larger than 2 cm near the fistula area, unless it clears up before the treatment begins.
• You have narrowing or inflammation of the rectum or anus that would make surgery difficult or impossible.
• You are currently taking steroid medications (such as cortisone), or you have taken them in the past four weeks before the treatment injection.
• You have been diagnosed with cancer in the past 5 years, or currently have cancer.
• You have an immune system condition — either one you were born with or one you developed — that weakens your ability to fight infection.
• You have a known allergy or medical reason that prevents you from receiving local anaesthetics or a contrast dye used in MRI scans called gadolinium.
• You cannot have an MRI scan — for example, because you have a pacemaker, certain metal implants, an insulin pump, cochlear implants, or other electronic or metal devices in your body.
• You received a specific treatment called darvadstrocel less than 6 months before enrolling in this trial.
• You have a medical condition that means you cannot safely receive general anaesthesia.
• Your body mass index (BMI) is below 18, as the procedure requires a sufficient amount of body fat tissue (confirm with trial site).
• You have a blood clotting disorder that would make surgery unsafe.
• You have a known allergy to human albumin (a protein used in some medical products).
• You are currently participating in another clinical treatment trial (observation-only studies are generally allowed — confirm with trial site).
• You fall into certain legally protected groups, including pregnant or breastfeeding women, people in custody, people in vulnerable social situations, or adults who are legally unable to give their own informed consent.

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