Intralesional Tolerogenic Dendritic Cells in Crohn's Disease Treatment

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02622763
• Date of registration: 01/12/2015
• Prospective Registration: No
• Primary sponsor: Fundacion Clinic per a la Recerca Biomédica
• Public title: Intralesional Tolerogenic Dendritic Cells in Crohn's Disease Treatment TolDecCDintra
• Scientific title: Safety and Clinical Efficacy Evaluation of Intralesional Administration of Tolerogenic Dendritic Cells in Patients With Refractory Crohn's Disease
• Date of first enrolment: November 2015
• Target sample size: 3
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT02622763
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Other. Masking: Single (Investigator).
• Phase: Phase 1

Countries of recruitment

Spain

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 65 Years
Gender: All

Health Condition(s) or Problem(s) studied

Crohn's Disease

Intervention(s)

Biological: Tolerogenic Dendritic Cells

Primary Outcome(s)

Proportion of patients with clinical response defined as a decrease of Crohn 's Disease Activity Index > 100 points [Time Frame: up to 12 weeks]

Number of adverse events [Time Frame: from inclusion up to 12 weeks]

Secondary Outcome(s)

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 proportion of patients in clinical remission defined as Crohn 's Disease Activity Index < 150 points [Time Frame: at week 12]

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 evaluation of quality of life will be held by Inflammatory bowel disease questionnaire Immunological endpoints [Time Frame: Change from baseline to week 12]

Secondary ID(s)

TolDec-CD-intra

2014-001083-35

Source(s) of Monetary Support

Please refer to primary and secondary sponsors