Intralesional Tolerogenic Dendritic Cells in Crohn's Disease Treatment.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Enrollment
3
Intralesional administration
Hospital Clinic of Barcelona
Barcelona, Spain
Number of adverse events
Time frame: from inclusion up to 12 weeks
Proportion of patients with clinical response defined as a decrease of Crohn 's Disease Activity Index > 100 points
Time frame: up to 12 weeks
The proportion of patients with clinical response defined as a decrease of Crohn 's Disease Activity Index > 100 points
Time frame: from baseline to week 12
The proportion of patients in clinical remission defined as Crohn 's Disease Activity Index < 150 points
Time frame: at week 12
Endoscopic lesions using the Crohn 's Disease Endoscopic Index of Severity ". Endoscopic remission was defined as the absence of ulcers
Time frame: at baseline and week 12
The evaluation of quality of life will be held by Inflammatory bowel disease questionnaire Immunological endpoints
Time frame: Change from baseline to week 12
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