Intralesional Tolerogenic Dendritic Cells in Crohn's Disease Treatment

Phase 1

Terminated

• Conditions: Crohn's Disease
• Interventions: Biological: Tolerogenic Dendritic Cells

• Registration Number: NCT02622763
• Lead Sponsor: Fundacion Clinic per a la Recerca Biomédica

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.

Study Timeline

• Study Start: 2015-11
• Study First Submitted: 2015-12-01
• Study First Submitted QC: 2015-12-03
• Study First Posted: 2015-12-04
• Primary Completion: 2019-05-05
• Study Completion: 2019-05-05
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-26
• Last Update Posted: 2020-02-28

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 3

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
10 millions dose	Tolerogenic Dendritic Cells	a total of 10 millions tolerogenic dendritic cells
100 millions dose	Tolerogenic Dendritic Cells	a total of 100 millions tolerogenic dendritic cells

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Hospital Clinic of Barcelona; 🇪🇸 Barcelona, Spain