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 @ 5:08 PM
Ignite Modification Date:
2025-12-24 @ 5:08 PM
NCT ID:
NCT01157650
Eligibility Criteria:
Inclusion Criteria:
1. Fistulizing Crohn´s disease patients with 1 or more enterocutaneous fistulas, recto-vaginal fistula or complex perianal fistula. The complex perianal fistula is defined as a fistula presenting one of these conditions:
* Trans-sphincteric, supra-sphincteric or extra-sphincteric tract, determined with:
* Clinical criteria: No palpation of the tract and surgical exploration
* Radiological criteria: Nucleal Magnetic Resonance (NMR)or Echoendoscopy
* Multiple fistulas
* "Horseshoe" fistula
* Any fistula with fecal incontinence associated
* Any fistula with a risk of fecal incontinence as a result of:
* previous anal fistula surgery or other perianal pathology (hemorrhoids, fissures), that involves lesions or muscular complications.
* Obstetric or iatrogenic sphincter lesions
2. Patients with Crohn Disease (CD) at screening and been diagnosed within 12 months before acceptance of clinical, endoscopical, anatomopathological and/or radiological criteria and have a non-active CD.(Crohn´s Disease Activity Index (CDAI)≤ 200)
3. \> 18 Years and both genders eligible.
4. Negative pregnancy test In female fertile subjects
5. Patient must voluntary sign the informed consent before performance of any study-related procedure not part of normal medical care.
6. Patient is, in the investigator's opinion, willing and able to comply with the protocol requirements
Exclusion Criteria:
1. Patients with a highly active CD, i.e., if they meet any of the following criteria:
* Presence of severe proctitis (prominent friability, spontaneous bleeding, multiple erosions, deep ulcers) or dominant active luminal disease that requires immediate treatment, revealed by rectosigmoidoscopy
* CDAI ≥201
2. Presence of abscess or other collections not drained (revealed by basal radiologic study).
3. Presence of setons drainage, unless they are removed before treatment beginning.
4. Rectal and/ or anal stenosis revealed with rectoscopy or EBA.
5. Patients needs surgery in the perianal region for other reasons than fistulas at inclusion or within 26 weeks after treatment administration.
6. Patients who have received infliximab or any other anti-TNF agent within 8 weeks before the cell treatment administration.
7. Patients who have received tacrolimus or cyclosporine within 4 weeks before cell treatment.
8. Patients with a history of alcohol or other addictive substances abuse within 6 months before inclusion.
9. Severe uncontrolled diseases (chronic renal failure, cardio, pulmonary,…).
10. Any type of medical or psychiatric disease which are considered as exclusion criteria, in the investigator's opinion.
11. Patients with diagnosis of malignant neoplasia, except basal cell or epidermoid carcinoma of the skin or previous history of malignant tumours, except those that have no evidence of relapse for at least 5 years.
12. Subjects with congenital or acquired immunodeficiency.
13. Positive serology for Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV) or Hepatitis C Virus (HCV).
14. Patient had major surgery or serious traumatism within 6 weeks before enrolment.
15. Pregnant or breast-feeding women.
16. Physical or psychical impossibility of following the protocol requirements
17. Patients who are receiving or received other investigational drugs within 30 days prior to basal visit.
18. Impossibility of doing an radiological exploration (reaction to contrast material, pacemakers, claustrophobia,…)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01157650
Study Brief:
Protocol Section:
NCT01157650