Intralesional Tolerogenic Dendritic Cells in Crohn's Disease Treatment
NCT ID: NCT02622763
Last Updated: 2020-02-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE1
3 participants
INTERVENTIONAL
2015-11-30
2019-05-05
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
SINGLE
Study Groups
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10 millions dose
a total of 10 millions tolerogenic dendritic cells
Tolerogenic Dendritic Cells
Intralesional administration
100 millions dose
a total of 100 millions tolerogenic dendritic cells
Tolerogenic Dendritic Cells
Intralesional administration
Interventions
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Tolerogenic Dendritic Cells
Intralesional administration
Eligibility Criteria
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Inclusion 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
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
18 Years
65 Years
ALL
No
Sponsors
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Fundacion Clinic per a la Recerca Biomédica
OTHER
Responsible Party
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Sara Varea
Clinical Research Manager
Locations
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Hospital Clinic of Barcelona
Barcelona, , Spain
Countries
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Other Identifiers
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2014-001083-35
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
TolDec-CD-intra
Identifier Type: -
Identifier Source: org_study_id
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