Intralesional Tolerogenic Dendritic Cells in Crohn's Disease Treatment (TolDecCDintra)

Fundacion Clinic per a la Recerca Biomédica

Status and phase: Terminated; Phase 1

Conditions: Crohn's Disease

Treatments: Biological: Tolerogenic Dendritic Cells

Study type: Interventional

Funder types: Other

Identifiers

NCT02622763

2014-001083-35 (EudraCT Number)

TolDec-CD-intra

Details and patient eligibility

About

Intralesional Tolerogenic Dendritic Cells in Crohn's Disease Treatment.

Full 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.

Enrollment: 3 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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3 participants in 2 patient groups

10 millions dose

Experimental group

Description:

a total of 10 millions tolerogenic dendritic cells

Treatment:

Biological: Tolerogenic Dendritic Cells

100 millions dose

Experimental group

Description:

a total of 100 millions tolerogenic dendritic cells

Treatment:

Biological: Tolerogenic Dendritic Cells