A Study to Evaluate a Leukapheresis Treatment in Patients With Ulcerative Colitis

Ulcerative Colitis Clinical Trial

Official title:

A Randomized Placebo Controlled, Single Centre Study to Evaluate a Novel Leukapheresis Treatment in Patients With Ulcerative Colitis.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01097590
• Other study ID #: TLA001
• Secondary ID: 461:2009/501
• Status: Completed
• Phase: Phase 1
• First received: March 25, 2010
• Last updated: August 20, 2013
• Start date: March 2010
• Est. completion date: November 2011

Study information

• Verified date: March 2010
• Source: IBD Column Therapies International AB
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Medical Products Agency
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine whether a treatment of a novel leukapheresis column is safe and effective in patients with moderate to severe ulcerative colitis.

Description:

Ulcerative colitis (UC) is a chronic and relapsing disease and is characterized by superficial inflammation in the colonic epithelium. The inflammation is maintained by continuous supply of inflammatory cells from the circulating blood to the intestinal mucosa.

Existing therapy e.g. corticosteroids and immunosuppressants are inadequate with an overall long-term remission rate of only 50-60%. Those treatments are also associated with severe side effects why there is a need of new therapies.

The aim of this study is to investigate a novel leukapheresis treatment with the potential to reduce the number of inflammatory cells homing to the gut mucosa. By drawing blood from the patient and pass it through the investigational column the inflammatory cells are removed. The blood, depleted of the inflammatory cells, is returned to the patient.

The treatment thus enable down-regulation of the inflammation and consequently the inflammation can heal. The treatment is called Tailored leukapheresis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: November 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Clinical diagnosis of active, moderate-to-severe, Ulcerative Colitis.

Exclusion criteria;

• Local intestinal treatments with suppositories, enemas or clysmas during the last 4 weeks

• Current daily smoking habits

• Other severe diseases as detailed in the protocol

• History of hypersensitivity to heparin

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer
• Ulcerative Colitis

Intervention

Device:
• Active TLA Gut™ column
Five consecutive treatment sessions. The therapy will be administrated every second day.
• Placebo
Five consecutive treatment sessions. The placebo therapy will be administrated every second day.

Locations

Country	Name	City	State
Sweden	Södersjukhuset	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
IBD Column Therapies International AB

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Expression level of MHC class II on antigen presenting cells.	The primary outcome will be assessed by flow cytometry.	change from baseline at day 5, 12, 28, 42 and 98.	Yes
Secondary	The number of cells and/or expression level of gut homing and activation markers on lymphocytes and monocytes. Safety and tolerability. Clinical effect on signs and symptoms of the disease.	The immunological analysis will be peformed by flow cytometry.; The safety will be measured by recording adverese events at each visit.; The disease activity will be assessed by using the Mayo Score Questionnaire.	change from baseline at day 5, 12,28, 42, 98.	Yes