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 @ 2:35 PM
Ignite Modification Date:
2025-12-24 @ 2:35 PM
NCT ID:
NCT03219359
Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of Crohn's disease by standard criteria
* Active disease based on clinical symptoms, defined as CDAI \>250. In patients with an ostomy, the number of liquid stools score in the CDAI will be replaced by the number of times that the ostomy bag is emptied daily.
* Active disease based on endoscopic evaluation, defined as SES-CD score \> 3 in at least one bowel segment
* Failure to respond to (or intolerant/adverse reaction to or declines) a member of each of the class of drugs listed below:
1. corticosteroids
2. azathioprine,
3. 6-mercaptopurine, methotrexate
4. Anti-TNFα (infliximab, adalimumab, certolizumab, golimumab)
5. Anti-integrin agents (natalizumab, vedolizumab)
6. Ustekinumab
* Failure to respond refers to ongoing objective inflammation with symptoms and, as is traditional, is defined by the gastroenterologist evaluating the patient.
* No surgical therapeutic option secondary to risk of short bowel syndrome or patient refusal
Exclusion Criteria:
* History of significant toxicity to any medications used in trial (cyclophosphamide, thymoglobulin, vedolizumab)
* Pregnant or breastfeeding
* Age \<18
* Karnofsky Performance Score \<60
* Patients who have an uncontrolled infection (presumed or documented) despite appropriate therapy for at least one month
* Patients with symptomatic coronary artery disease or uncontrolled congestive heart failure.
* HIV infected
* Ejection fraction \<30% or requiring supplemental continuous oxygen.
* DLCO \<35% or requiring supplementary oxygen.
* Patients for whom an insufficient number of stem cells (\<2 X 10\^6/kg) have been collected.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03219359
Study Brief:
Protocol Section:
NCT03219359