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Completed

NCT Number: NCT01097590

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.

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Key information

Conditions

Ulcerative Colitis Colitis Colitis, Ulcerative Colonic Diseases Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Södersjukhuset

Stockholm, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Active TLA Gut™ column

Device

Five consecutive treatment sessions. The therapy will be administrated every second day.

Other names: TLA Gut™

PLACEBO

Device

Five consecutive treatment sessions. The placebo therapy will be administrated every second day.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

IBD Column Therapies International AB

Industry

Registry information

Official study title

A Randomized Placebo Controlled, Single Centre Study to Evaluate a Novel Leukapheresis Treatment in Patients With Ulcerative Colitis.

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Apr 1, 2010
Registry last updated
Aug 21, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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