Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:24 PM
Ignite Modification Date:
2025-12-24 @ 4:24 PM
NCT ID:
NCT05407766
Eligibility Criteria:
Inclusion Criteria:
* Men and Women 18-75 years of age with a diagnosis of unhealing perianal fistulas in the setting of Crohn's disease and must be on maximal standard of care therapy (e.g., antibiotics, 5-ASA, and immunomodulator, anti-TNF, anti-integrin, and anti-interleukin therapies) for at least six months duration.
* Presence of perianal fistula with maximum of two internal fistula tracts and a maximum of three external openings based on clinical assessment and MRI. Fistula must have been draining for at least 6 weeks prior to the screening visit.
* Medically refractory perianal fistulizing Crohn's disease (i.e., standard of care such as antibiotics, immunosuppressives)
* Have no contraindications to MR evaluations: e.g., pacemaker or magnetically active metal fragments, claustrophobia
* Ability to comply with protocol
* Competent and able to provide written informed consent
* Concurrent Crohn's-related therapies with stable doses corticosteroids, 5- ASA drugs, immunomodulators, anti-TNF therapy, anti-integrin and anti-interleukin therapies are permitted.
* A female participant and of childbearing potential must have a negative serum or urine pregnancy test at time of screening, and must not plan to become pregnant during the study.
Exclusion Criteria:
* Inability to give informed consent.
* Clinically significant medical conditions within the six months before administration of MSCs: e.g. myocardial infarction, active angina, congestive heart failure or other conditions that would, in the opinion of the investigators, compromise the safety of the patient.
* Specific exclusions: Hepatitis B or C, HIV, Abnormal AST or ALT at screening
* History of cancer including melanoma (with the exception of localized skin cancers) in the past five years
* Received treatment with an investigational drug or device within 60 days of randomization or have not completed 5 half-life washout (whichever is later) for drugs or biologics. If the half-life of the product is not known, then subjects cannot be randomized within 6 months of investigation drug treatment.
* Participated in a cell therapy-based trial within 6 months before randomization
* Participated in Crohn's/ulcerative colitis or any fistulizing Crohn's study within 6 months before randomization
* Pregnant or breast feeding or trying to become pregnant.
* Presence of a rectovaginal or perineal body fistula
* Change in Crohn's immunosuppressive regimen prior to enrollment. Subjects should be on stable, maximal medical therapy for 4 months prior to enrollment.
* Uncontrolled intestinal Crohn's disease which will require escalation for medical therapy or surgery within 3 months of enrollment
* Severe anal canal disease that is stenotic and requires dilation or severe proctitis making difficult to the surgery
* A female or male participant unwilling to agree to use acceptable contraception methods during participation in study. Acceptable contraception methods include: Implants, injectables, combined oral contraceptives, an intrauterine device, a bilateral tubal ligation, a vasectomy, a vasectomized partner for female participant, double-barrier methods, and physical barrier if male participant is not vasectomized
* Associated perianal abscess(es).
* Laboratory exclusions: Serum creatinine levels \>1.5 times the upper limit of normal (ULN). Total bilirubin \>1.5 × ULN. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \>5.0 × ULN. Hemoglobin \<10.0 g/dL for females or \<11.0 g/dL for males. Platelets \<75.0 × 109/L.
* Any contraindications to MRI or surgical or anesthetic procedure(s)
* Any major GI surgery or major perianal local surgery within 6 months of randomization
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT05407766
Study Brief:
Protocol Section:
NCT05407766