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

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

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.

Study Overview

• Status: Completed
• Conditions: Ulcerative Colitis
• Intervention / Treatment: Device: Active TLA Gut™ column; Device: Placebo

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 23
• Phase: Phase 1

Contacts and Locations

Study Locations

• Sweden
  • Stockholm, Sweden
    • Sodersjukhuset

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Active TLA Gut™ column; The active column contain an engineered protein with the ability to specifically bind the inflammatory cells.	Device: Active TLA Gut™ column; Five consecutive treatment sessions. The therapy will be administrated every second day.; Other Names: TLA Gut™
Placebo Comparator: Placebo TLA Gut™column; The placebo column is identical to the active column except it does not contain the engineered protein that specifically bind the inflammatory cells.	Device: Placebo; Five consecutive treatment sessions. The placebo therapy will be administrated every second day.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

• Sponsor: IBD Column Therapies International AB
• Investigators: Principal Investigator: Michael Eberhardson, Dr, Karolinska Universitetssjukhuset 171 76 Stockholm

Study record dates

Study Major Dates

• Study Start: March 1, 2010
• Primary Completion (Actual): October 1, 2011
• Study Completion (Actual): November 1, 2011

Study Registration Dates

• First Submitted: March 25, 2010
• First Submitted That Met QC Criteria: March 31, 2010
• First Posted (Estimate): April 1, 2010

Study Record Updates

• Last Update Posted (Estimate): August 21, 2013
• Last Update Submitted That Met QC Criteria: August 20, 2013
• Last Verified: March 1, 2010

More Information

Terms related to this study

• Keywords: ulcerative colitis; leukapheresis treatment
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Gastrointestinal Diseases; Gastroenteritis; Colonic Diseases; Intestinal Diseases; Inflammatory Bowel Diseases; Ulcer; Colitis; Colitis, Ulcerative
• Other Study ID Numbers: TLA001; 461:2009/501 (Other Identifier: Medical Products Agency)