Clinical trial NCT02622763: Intralesional Tolerogenic Dendritic Cells in Crohn's Disease Treatment
Official title: Safety and Clinical Efficacy Evaluation of Intralesional Administration of Tolerogenic Dendritic Cells in Patients With Refractory Crohn's Disease
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Crohn's Disease
Keywords: Tolerogenic Dendritic Cells
Lead sponsor: Fundacion Clinic per a la Recerca Biomédica
Sponsor class: OTHER
First posted: 2015-12-04
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Intralesional Tolerogenic Dendritic Cells in Crohn's Disease Treatment.

Detailed description: The main objective is to evaluate the safety and clinical response of intralesional injection of Autologous peripheral blood differentiated adult dendritic cells expanded tolerogenic in patients with refractory Crohn's disease treatment.

Eligibility criteria: Inclusion Criteria:

1. Confirmed diagnosis of Crohn's disease ( Lennard -Jones criteria )
2. Active Crohn's disease in the last six months to the inclusion defined as : CDAI? 220 and endoscopic or radiological criteria of activity
3. Refractory or intolerance to conventional therapy including corticosteroids , immunomodulators and anti-tumor necrosis factor-alpha
4. Presence of visible lesions by endoscopy
5. Acceptance to participate in the study and written informed consent

Exclusion Criteria:

1. No injuries in pre-screening resonance
2. Pregnancy, lactation or women of childbearing age not taking appropriate contraceptive measures
3. Patients HIV + and Hepatitis C Virus + Hepatitis B Virus +
4. Serious concomitant disease:

   * Renal failure with creatinine clearance \< 40ml / min
   * Heart disease: congestive heart failure with ejection fraction \< 45 % , atrial fibrillation treated with oral anticoagulants, uncontrolled ventricular arrhythmias , pericarditis , pleural effusion with hemodynamic
   * Neoplasms or myelodysplasia
   * Psychiatric disorders including alcohol and drugs
5. Symptoms attributable to fibrotic strictures in Crohn's disease at the discretion of the investigators
6. Diarrhea attributable to " short bowel syndrome"
7. Active infection , including tuberculosis
8. Participation in research studies of new drugs in the 3 months prior to inclusion.
9. Vaccination with live/attenuated germs in the previous 3 months
10. Personal history of cancer (active or complete remission) or known family history of hereditary cancer.
11. Patients in whom , after observation of the state of their veins , these are considered inaccessible and impossible to perform apheresis

Primary outcomes:
measure: Number of adverse events
timeFrame: from inclusion up to 12 weeks
measure: Proportion of patients with clinical response defined as a decrease of Crohn 's Disease Activity Index > 100 points
timeFrame: up to 12 weeks
Secondary outcomes:
measure: The proportion of patients with clinical response defined as a decrease of Crohn 's Disease Activity Index > 100 points
timeFrame: from baseline to week 12
measure: The proportion of patients in clinical remission defined as Crohn 's Disease Activity Index < 150 points
timeFrame: at week 12
measure: Endoscopic lesions using the Crohn 's Disease Endoscopic Index of Severity ". Endoscopic remission was defined as the absence of ulcers
timeFrame: at baseline and week 12
measure: The evaluation of quality of life will be held by Inflammatory bowel disease questionnaire Immunological endpoints
timeFrame: Change from baseline to week 12
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital Clinic of Barcelona
Study officials:
References: