A Study to Evaluate a 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.
Device: Active TLA Gut™ column
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||A Randomized Placebo Controlled, Single Centre Study to Evaluate a Novel Leukapheresis Treatment in Patients With Ulcerative Colitis.|
- Expression level of MHC class II on antigen presenting cells. [ Time Frame: change from baseline at day 5, 12, 28, 42 and 98. ] [ Designated as safety issue: Yes ]The primary outcome will be assessed by flow cytometry.
- 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. [ Time Frame: change from baseline at day 5, 12,28, 42, 98. ] [ Designated as safety issue: Yes ]
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.
|Study Start Date:||March 2010|
|Study Completion Date:||November 2011|
|Primary Completion Date:||October 2011 (Final data collection date for primary outcome measure)|
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 Name: 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.
Five consecutive treatment sessions. The placebo therapy will be administrated every second day.
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.
|Principal Investigator:||Michael Eberhardson, Dr||Karolinska Universitetssjukhuset 171 76 Stockholm|