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| ID | Type | Description | Link |
|---|---|---|---|
| 461:2009/501 | Other Identifier | Medical Products Agency |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active TLA Gut™ column | Experimental | The active column contain an engineered protein with the ability to specifically bind the inflammatory cells. |
|
| Placebo TLA Gut™column | Placebo Comparator | The placebo column is identical to the active column except it does not contain the engineered protein that specifically bind the inflammatory cells. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Active TLA Gut™ column | Device | Five consecutive treatment sessions. The therapy will be administrated every second day. |
|
| 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. |
| 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. |
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Inclusion Criteria:
Exclusion criteria;
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| Name | Affiliation | Role |
|---|---|---|
| Michael Eberhardson, Dr | Karolinska Universitetssjukhuset 171 76 Stockholm | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Södersjukhuset | Stockholm | Sweden |
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| ID | Term |
|---|---|
| D003093 | Colitis, Ulcerative |
| ID | Term |
|---|---|
| D003092 | Colitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| Placebo | Device | Five consecutive treatment sessions. The placebo therapy will be administrated every second day. |
|
| change from baseline at day 5, 12,28, 42, 98. |
| D015212 |
| Inflammatory Bowel Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |