NCT02622763

Brief Summary

Intralesional Tolerogenic Dendritic Cells in Crohn's Disease Treatment.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Nov 2015

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2015

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 1, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 4, 2015

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 5, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 5, 2019

Completed
Last Updated

February 28, 2020

Status Verified

February 1, 2020

Enrollment Period

3.5 years

First QC Date

December 1, 2015

Last Update Submit

February 26, 2020

Conditions

Crohn's Disease

Keywords

Tolerogenic Dendritic Cells

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (4)

  • 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

Study Arms (2)

10 millions dose

EXPERIMENTAL

a total of 10 millions tolerogenic dendritic cells

Biological: Tolerogenic Dendritic Cells

100 millions dose

EXPERIMENTAL

a total of 100 millions tolerogenic dendritic cells

Biological: Tolerogenic Dendritic Cells

Interventions

Tolerogenic Dendritic CellsBIOLOGICAL

Intralesional administration

10 millions dose100 millions dose

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Confirmed diagnosis of Crohn's disease ( Lennard -Jones criteria )
  • 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

You may not qualify if:

  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Clinic of Barcelona

Barcelona, 08036, Spain

Location

MeSH Terms

Conditions

Crohn Disease

Condition Hierarchy (Ancestors)

Inflammatory Bowel DiseasesGastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Research Manager

Study Record Dates

First Submitted

December 1, 2015

First Posted

December 4, 2015

Study Start

November 1, 2015

Primary Completion

May 5, 2019

Study Completion

May 5, 2019

Last Updated

February 28, 2020

Record last verified: 2020-02

Locations

ES(1)