Intralesional Tolerogenic Dendritic Cells in Crohn's Disease Treatment

Crohn's Disease Clinical Trial

— TolDecCDintra  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02622763
• Other study ID #: TolDec-CD-intra
• Secondary ID: 2014-001083-35
• Status: Terminated
• Phase: Phase 1
• Start date: November 2015
• Est. completion date: May 5, 2019

Study information

• Verified date: February 2020
• Source: Fundacion Clinic per a la Recerca Biomédica
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Intralesional Tolerogenic Dendritic Cells in Crohn's Disease Treatment.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: May 5, 2019
• Est. primary completion date: May 5, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Crohn Disease
• Crohn's Disease

Intervention

Biological:
• Tolerogenic Dendritic Cells
Intralesional administration

Locations

Country	Name	City	State
Spain	Hospital Clinic of Barcelona	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Fundacion Clinic per a la Recerca Biomédica

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of adverse events		from inclusion up to 12 weeks
Primary	Proportion of patients with clinical response defined as a decrease of Crohn 's Disease Activity Index > 100 points		up to 12 weeks
Secondary	The proportion of patients with clinical response defined as a decrease of Crohn 's Disease Activity Index > 100 points		from baseline to week 12
Secondary	The proportion of patients in clinical remission defined as Crohn 's Disease Activity Index < 150 points		at week 12
Secondary	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
Secondary	The evaluation of quality of life will be held by Inflammatory bowel disease questionnaire Immunological endpoints		Change from baseline to week 12