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

Safety and Clinical Efficacy Evaluation of Intralesional Administration of Tolerogenic Dendritic Cells in Patients With Refractory Crohn's Disease

Intralesional Tolerogenic Dendritic Cells in Crohn's Disease Treatment.

Study Overview

• Status: Terminated
• Conditions: Crohn's Disease
• Intervention / Treatment: Biological: Tolerogenic Dendritic Cells

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 Type: Interventional
• Enrollment (Actual): 3
• Phase: Phase 1

Contacts and Locations

Study Locations

• Spain
  • Barcelona, Spain, 08036
    • Hospital Clinic of Barcelona

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 10 millions dose; a total of 10 millions tolerogenic dendritic cells	Biological: Tolerogenic Dendritic Cells; Intralesional administration
Experimental: 100 millions dose; a total of 100 millions tolerogenic dendritic cells	Biological: Tolerogenic Dendritic Cells; Intralesional administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Fundacion Clinic per a la Recerca Biomédica

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2015
• Primary Completion (Actual): May 5, 2019
• Study Completion (Actual): May 5, 2019

Study Registration Dates

• First Submitted: December 1, 2015
• First Submitted That Met QC Criteria: December 3, 2015
• First Posted (Estimate): December 4, 2015

Study Record Updates

• Last Update Posted (Actual): February 28, 2020
• Last Update Submitted That Met QC Criteria: February 26, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: Tolerogenic Dendritic Cells
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Inflammatory Bowel Diseases; Crohn Disease
• Other Study ID Numbers: TolDec-CD-intra; 2014-001083-35 (EudraCT Number)