Ulcerative Colitis
Conditions
Keywords
ulcerative colitis, leukapheresis treatment
Brief 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.
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.
Interventions
DEVICEActive TLA Gut™ column
Five consecutive treatment sessions. The therapy will be administrated every second day.
DEVICEPlacebo
Five consecutive treatment sessions. The placebo therapy will be administrated every second day.
Sponsors
IBD Column Therapies International AB
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Expression level of MHC class II on antigen presenting cells. | change from baseline at day 5, 12, 28, 42 and 98. | The primary outcome will be assessed by flow cytometry. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 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. |
Countries
Sweden
Outcome results
None listed