Intralesional Tolerogenic Dendritic Cells in Crohn's Disease Treatment

Study Overview
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Brief Summary
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Intralesional Tolerogenic Dendritic Cells in Crohn's Disease Treatment.

Detailed Description
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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.

Official Title
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Safety and Clinical Efficacy Evaluation of Intralesional Administration of Tolerogenic Dendritic Cells in Patients With Refractory Crohn's Disease

Conditions
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Crohn's Disease

Intervention / Treatment
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* Biological: Tolerogenic Dendritic Cells


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Confirmed diagnosis of Crohn's disease ( Lennard -Jones criteria ) Active Crohn's disease in the last six months to the inclusion defined as : CDAI? 220 and endoscopic or radiological criteria of activity Refractory or intolerance to conventional therapy including corticosteroids , immunomodulators and anti-tumor necrosis factor-alpha Presence of visible lesions by endoscopy Acceptance to participate in the study and written informed consent Exclusion Criteria: No injuries in pre-screening resonance Pregnancy, lactation or women of childbearing age not taking appropriate contraceptive measures Patients HIV + and Hepatitis C Virus + Hepatitis B Virus + 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 Symptoms attributable to fibrotic strictures in Crohn's disease at the discretion of the investigators Diarrhea attributable to  short bowel syndrome Active infection , including tuberculosis Participation in research studies of new drugs in the 3 months prior to inclusion. Vaccination with live/attenuated germs in the previous 3 months Personal history of cancer (active or complete remission) or known family history of hereditary cancer. Patients in whom , after observation of the state of their veins , these are considered inaccessible and impossible to perform apheresis

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 10 millions dose<br>a total of 10 millions tolerogenic dendritic cells | Biological: Tolerogenic Dendritic Cells<br>* Intralesional administration<br>|
| Experimental: 100 millions dose<br>a total of 100 millions tolerogenic dendritic cells | Biological: Tolerogenic Dendritic Cells<br>* Intralesional administration<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of adverse events |  | from inclusion up to 12 weeks | 
| Proportion of patients with clinical response defined as a decrease of Crohn 's Disease Activity Index > 100 points |  | up to 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The proportion of patients with clinical response defined as a decrease of Crohn 's Disease Activity Index > 100 points |  | from baseline to week 12 | 
| The proportion of patients in clinical remission defined as Crohn 's Disease Activity Index < 150 points |  | at week 12 | 
| Endoscopic lesions using the Crohn 's Disease Endoscopic Index of Severity . Endoscopic remission was defined as the absence of ulcers |  | at baseline and week 12 | 
| The evaluation of quality of life will be held by Inflammatory bowel disease questionnaire Immunological endpoints |  | Change from baseline to week 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tolerogenic Dendritic Cells