search
Back to results

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

Primary Purpose

Crohn's Disease

Status
Terminated
Phase
Phase 1
Locations
Spain
Study Type
Interventional
Intervention
Tolerogenic Dendritic Cells
Sponsored by
Fundacion Clinic per a la Recerca Biomédica
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Crohn's Disease focused on measuring Tolerogenic Dendritic Cells

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Hospital Clinic of Barcelona

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

10 millions dose

100 millions dose

Arm Description

a total of 10 millions tolerogenic dendritic cells

a total of 100 millions tolerogenic dendritic cells

Outcomes

Primary Outcome Measures

Number of adverse events
Proportion of patients with clinical response defined as a decrease of Crohn 's Disease Activity Index > 100 points

Secondary Outcome Measures

The proportion of patients with clinical response defined as a decrease of Crohn 's Disease Activity Index > 100 points
The proportion of patients in clinical remission defined as Crohn 's Disease Activity Index < 150 points
Endoscopic lesions using the Crohn 's Disease Endoscopic Index of Severity ". Endoscopic remission was defined as the absence of ulcers
The evaluation of quality of life will be held by Inflammatory bowel disease questionnaire Immunological endpoints

Full Information

First Posted
December 1, 2015
Last Updated
February 26, 2020
Sponsor
Fundacion Clinic per a la Recerca Biomédica
search

1. Study Identification

Unique Protocol Identification Number
NCT02622763
Brief Title
Intralesional Tolerogenic Dendritic Cells in Crohn's Disease Treatment
Acronym
TolDecCDintra
Official Title
Safety and Clinical Efficacy Evaluation of Intralesional Administration of Tolerogenic Dendritic Cells in Patients With Refractory Crohn's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Terminated
Why Stopped
low recruitment
Study Start Date
November 2015 (Actual)
Primary Completion Date
May 5, 2019 (Actual)
Study Completion Date
May 5, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fundacion Clinic per a la Recerca Biomédica

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohn's Disease
Keywords
Tolerogenic Dendritic Cells

7. Study Design

Primary Purpose
Other
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
3 (Actual)

8. Arms, Groups, and Interventions

Arm Title
10 millions dose
Arm Type
Experimental
Arm Description
a total of 10 millions tolerogenic dendritic cells
Arm Title
100 millions dose
Arm Type
Experimental
Arm Description
a total of 100 millions tolerogenic dendritic cells
Intervention Type
Biological
Intervention Name(s)
Tolerogenic Dendritic Cells
Intervention Description
Intralesional administration
Primary Outcome Measure Information:
Title
Number of adverse events
Time Frame
from inclusion up to 12 weeks
Title
Proportion of patients with clinical response defined as a decrease of Crohn 's Disease Activity Index > 100 points
Time Frame
up to 12 weeks
Secondary Outcome Measure Information:
Title
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
Title
The proportion of patients in clinical remission defined as Crohn 's Disease Activity Index < 150 points
Time Frame
at week 12
Title
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
Title
The evaluation of quality of life will be held by Inflammatory bowel disease questionnaire Immunological endpoints
Time Frame
Change from baseline to week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Confirmed diagnosis of Crohn's disease ( Lennard -Jones criteria ) Active Crohn's disease in the last six months to the inclusion defined as : CDAI? 220 and endoscopic or radiological criteria of activity Refractory or intolerance to conventional therapy including corticosteroids , immunomodulators and anti-tumor necrosis factor-alpha Presence of visible lesions by endoscopy Acceptance to participate in the study and written informed consent Exclusion Criteria: No injuries in pre-screening resonance Pregnancy, lactation or women of childbearing age not taking appropriate contraceptive measures Patients HIV + and Hepatitis C Virus + Hepatitis B Virus + 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 Symptoms attributable to fibrotic strictures in Crohn's disease at the discretion of the investigators Diarrhea attributable to " short bowel syndrome" Active infection , including tuberculosis Participation in research studies of new drugs in the 3 months prior to inclusion. Vaccination with live/attenuated germs in the previous 3 months Personal history of cancer (active or complete remission) or known family history of hereditary cancer. Patients in whom , after observation of the state of their veins , these are considered inaccessible and impossible to perform apheresis
Facility Information:
Facility Name
Hospital Clinic of Barcelona
City
Barcelona
ZIP/Postal Code
08036
Country
Spain

12. IPD Sharing Statement

Learn more about this trial

Intralesional Tolerogenic Dendritic Cells in Crohn's Disease Treatment

We'll reach out to this number within 24 hrs