A Study to Evaluate a Leukapheresis Treatment in Patients With Ulcerative Colitis
|ClinicalTrials.gov Identifier: NCT01097590|
Recruitment Status : Completed
First Posted : April 1, 2010
Last Update Posted : August 21, 2013
|Condition or disease||Intervention/treatment||Phase|
|Ulcerative Colitis||Device: Active TLA Gut™ column Device: Placebo||Phase 1|
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 (Clinical Trial)|
|Actual Enrollment :||23 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Randomized Placebo Controlled, Single Centre Study to Evaluate a Novel Leukapheresis Treatment in Patients With Ulcerative Colitis.|
|Study Start Date :||March 2010|
|Actual Primary Completion Date :||October 2011|
|Actual Study Completion Date :||November 2011|
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.
- Expression level of MHC class II on antigen presenting cells. [ Time Frame: change from baseline at day 5, 12, 28, 42 and 98. ]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. ]
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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01097590
|Principal Investigator:||Michael Eberhardson, Dr||Karolinska Universitetssjukhuset 171 76 Stockholm|