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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2010 by IBD Column Therapies International AB.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
IBD Column Therapies International AB
ClinicalTrials.gov Identifier:
NCT01097590
First received: March 25, 2010
Last updated: July 22, 2011
Last verified: March 2010
History of Changes
  Purpose

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.


Condition Intervention Phase
Ulcerative Colitis
 Device: Active TLA Gut™ column
Device: Placebo
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Placebo Controlled, Single Centre Study to Evaluate a Novel Leukapheresis Treatment in Patients With Ulcerative Colitis.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by IBD Column Therapies International AB:

Primary Outcome Measures:
  • Expression level of MHC class II on antigen presenting cells. [ Time Frame: change from baseline at day 5, 12, 28, 42 and 98. ] [ Designated as safety issue: Yes ]
    The primary outcome will be assessed by flow cytometry.


Secondary Outcome Measures:
  • 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. ] [ Designated as safety issue: Yes ]

    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.



Estimated Enrollment: 25
Study Start Date: March 2010
Estimated Study Completion Date: March 2012
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
 Device: Placebo
Five consecutive treatment sessions. The placebo therapy will be administrated every second day.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01097590

Contacts
Contact: Michael Eberhardsson + 466163907

Locations
Sweden
Södersjukhuset Recruiting
Stockholm, Sweden
Contact: Per Karlén, Dr     +4686163114     Per.karlen@sodersjukhuset.se    
Contact: Annelie Lindberg, study nurse     + 4686163867     Annelie.lindberg@sodersjukhuset.se    
Principal Investigator: Per Karlén            
Sub-Investigator: Mats Karlsson            
Sub-Investigator: Michael Eberhardsson            
Sponsors and Collaborators
IBD Column Therapies International AB
Investigators
Principal Investigator: Michael Eberhardson, Dr Karolinska Universitetssjukhuset 171 76 Stockholm
  More Information

No publications provided

Responsible Party: Hans Glise, IBD Column Therapies International AB, Sweden
ClinicalTrials.gov Identifier: NCT01097590     History of Changes
Other Study ID Numbers: TLA001, 461:2009/501
Study First Received: March 25, 2010
Last Updated: July 22, 2011
Health Authority: Sweden: Medical Products Agency

Keywords provided by IBD Column Therapies International AB:
ulcerative colitis
leukapheresis treatment

Additional relevant MeSH terms:
Colitis
Colitis, Ulcerative
Ulcer
Gastroenteritis
Gastrointestinal Diseases
 Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Inflammatory Bowel Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on May 21, 2013