Crohn's Disease
Conditions
Keywords
Tolerogenic Dendritic Cells
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.
Interventions
BIOLOGICALTolerogenic Dendritic Cells
Intralesional administration
Sponsors
Fundacion Clinic per a la Recerca Biomédica
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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
| Measure | 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 |
Countries
Spain
Outcome results
None listed