Clinical trial to evaluate if the laparoscopic administration of cells derived from the fatty tissue can improve the inflammatory stenosis in patient with Crohn's disease.

Phase 1

Active, not recruiting

• Conditions: Inflammatory stenosis in patient with Crohn's disease.; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2021-006068-26-ES
• Lead Sponsor: FUNDACION JIMENEZ DIAZ HEALTH RESEARCH INSTITUTE

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-03-24
• Last Update Posted: 8 August 2022

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

1. Patients who agree to participate and agree to give their written consent. 2.
2.Patients over 18 years of age and under 75 years of age.
3.With Crohn's disease diagnosed at least 6 months earlier who meet clinical, endoscopic, histological and/or radiological criteria.
4.Presence of a single inflammatory stenotic lesion in the small bowel or ileocolic area with a maximum length of 5 cm, demonstrated by enteroresonance, producing episodes of intestinal occlusion/subocclusion. Other inflammatory lesions are acceptable, but only one should be identified as the obvious cause of the occlusion/subocclusion.
5.Patients treated with at least one biologic drug and with inadequate response to maintenance doses and prior to intensification (either dose, interval or change/addition of another drug):
a. anti-TNF (for at least 14 weeks, which includes induction and/or maintenance doses): Infliximab, Adalimumab, Certolizumab.
b.Anti-integrin(at least for 14 weeks, which includes induction and/or maintenance doses): Vedolizumab
c.Anti-IL-12/23(at least for 16 weeks, which includes induction and/or maintenance doses): Ustekinumab
6.Women of childbearing age must have a negative pregnancy test at screening and agree to use effective contraceptive measures for the duration of study participation*.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

Exclusion Criteria

1. Intra-abdominal abscesses larger than 3 cm not drained (surgically, by interventional radiology) or not treated with antibiotics. Patients may be included once the abscess has been drained (without the need to wait) or if they have received antibiotic treatment, once improvement has been confirmed with imaging tests.
2. Severe intestinal obstruction that requires urgent surgery
3. Active outbreak of Crohn's disease requiring medical treatment, defined as abdominal pain, fever, bloody diarrhea and CRP greater than 10. The patient may be included once the condition has resolved, when the patient is on maintenance medication.
4. History of previous invasive neoplasia in the last 5 years. Patients with completely resected basal cell carcinoma of the skin may be included
5. History in the last 6 months of severe, progressive or uncontrolled hepatic, hematological, gastrointestinal, renal, endocrine, pulmonary, cardiac, neurological or psychiatric disease.
6. Patients with primary sclerosing cholangitis.
7. Patients with known congenital or acquired immunodeficiency, including HIV.
8. Known allergy or hypersensitivity to penicillin or aminoglycosides; DMEN (dulbecco modified eagle's medium), bovine serum, local anesthetic or gadolinium.
9. Contraindication to perform MRI (pacemaker, hip replacement or severe claustrophobia) or receive contrast with gadolinium.
10. Patients unwilling or unable to comply with study procedures.
11. Patients who are receiving, or have received any investigational medication in the 3 months prior to the screening period.
12. Major surgery or severe trauma in the previous 6 months.
13. Pregnant or lactating women.
14. Patients who have contraindications for general anesthesia, locoregional (depending on the type of anesthesia required) or laparoscopy1. Intra-abdominal abscesses larger than 3 cm not drained (surgically, by interventional radiology) or not treated with antibiotics. Patients may be included once the abscess has been drained (without the need to wait) or if they have received antibiotic treatment, once improvement has been confirmed with imaging tests.
2. Severe intestinal obstruction that requires urgent surgery
3. Active outbreak of Crohn's disease requiring medical treatment, defined as abdominal pain, fever, bloody diarrhea and CRP greater than 10. The patient may be included once the condition has resolved, when the patient is on maintenance medication.
4. History of previous invasive neoplasia in the last 5 years. Patients with completely resected basal cell carcinoma of the skin may be included
5. History in the last 6 months of severe, progressive or uncontrolled hepatic, hematological, gastrointestinal, renal, endocrine, pulmonary, cardiac, neurological or psychiatric disease.
6. Patients with primary sclerosing cholangitis.
7. Patients with known congenital or acquired immunodeficiency, including HIV.
8. Known allergy or hypersensitivity to penicillin or aminoglycosides; DMEN (dulbecco modified eagle's medium), bovine serum, local anesthetic or gadolinium.
9. Contraindication to perform MRI (pacemaker, hip replacement or severe claustrophobia) or receive contrast with gadolinium.
10. Patients unwilling or unable to comply with study procedures.
11. Patients who are receiving, or have received any investigational medication in the 3 months prior to the screening period.
12. Major surgery or severe trauma in the previous 6 months.
13. Pregnant or lactating women.
14. Patients who have contr

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the feasibility and safety of laparoscopic administration of allogeneic adMSCs for the treatment of patients with inflammatory intestinal stenosis associated with Crohn's disease.;Secondary Objective: To evaluate the preliminary efficacy of the treatment.<br>To evaluate changes in the quality of life of treated patients using the IBDQ32 questionnaire.;Primary end point(s): - Complications during anesthesia: (depending on the type of anesthesia)<br><br>- Complications derived from the treatment administration procedure<br>o Associated with laparoscopy<br>o Associated with injection into perilesional fat<br>o Associated with the investigational drug;Timepoint(s) of evaluation of this end point: VISIT 0 TO VISIT 6

Secondary Outcome Measures

Name	Time	Method
Timepoint(s) of evaluation of this end point: 6, 12, 18, 24, 36 and 52 weeks;Secondary end point(s): - To evaluate the change in the length of the stenosis with respect to the baseline in the enteroMRI<br>- To assess the change in the CDAI questionnaire score from baseline at 6, 12, 18, 24, 36 and 52 weeks<br>- To assess the change in score from baseline on the IBDQ32 questionnaire at 24 and 52 weeks of treatment<br>- To describe the number of patients with an obstructive episode who required resection surgery during the study period.