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

IBD Column Therapies

Status and phase: Completed; Phase 1

Conditions: Ulcerative Colitis

Treatments: Device: Placebo; Device: Active TLA Gut™ column

Study type: Interventional

Funder types: Industry

Identifiers

NCT01097590

TLA001

461:2009/501 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 23 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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23 participants in 2 patient groups, including a placebo group

Active TLA Gut™ column

Experimental group

Description:

The active column contain an engineered protein with the ability to specifically bind the inflammatory cells.

Treatment:

Device: Active TLA Gut™ column

Placebo TLA Gut™column

Placebo Comparator group

Description:

The placebo column is identical to the active column except it does not contain the engineered protein that specifically bind the inflammatory cells.

Treatment:

Device: Placebo