A Study To Investigate The Safety And Possible Clinical Benefit Of Multistem(r) In Patients With Moderate To Severe Ulcerative Colitis

Last updated: January 26, 2016
Sponsor: Pfizer
Overall Status: Completed

Phase

2

Condition

Crohn's Disease

Inflammatory Bowel Disease

Treatment

N/A

Clinical Study ID

NCT01240915
B3041001
2010-022766-27
  • Ages > 18
  • All Genders

Study Summary

MultiStem(r) is a new biological product, manufactured from human stem cells obtained from adult bone marrow or other nonembryonic tissue sources. Factors expressed by MultiStem cells are believed to reduce inflammation and regulate immune system function, protect damaged or injured cells and tissue, promote formation of new blood vessels, and augment tissue repair and healing. MultiStem cell treatment resulted in significant efficacy in a mouse model of Graft versus Host Disease with almost complete reversal of gastrointestinal pathology (similar to pathology that would be expected in Ulcerative Colitis). These data, together with safety data generated in 2 other clinical trials, suggest that MultiStem has the potential to be a new treatment option for patients with ulcerative colitis. This is the first study of MultiStem in this patient population and will cautiously explore the safety/toleration and potential benefit of this new treatment in patients with moderate to severe disease.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Subjects must have a documented diagnosis of ulcerative colitis at least 6 monthsprior to screening.

  • Subjects must have active moderate-to-severe ulcerative colitis based on Mayo score.

  • Subjects must have Modified Baron endoscopic score of at least 2 determined within 7days of first dosing.

  • Subjects must have failed or be intolerant (as determined by the investigator) of atleast one of the following treatments for UC: Oral corticosteroids, azathioprine or 6-mercaptopurine (6-MP), or anti-tumor necrosis factor (TNF) therapy, eg, infliximabor adalimumab.

  • Subjects must be on stable steroid doses.

Exclusion

Exclusion Criteria:

  • Subjects who have abnormal organ and marrow function.

  • Subjects with a diagnosis of indeterminate colitis, or clinical findings suggestive ofCrohn's disease.

  • Subjects who meet Truelove-Witts criteria for severe ulcerative colitis.

  • Subjects receiving or who are expected to receive Infliximab or other biologictreatment within 8 weeks of the Day 1 study visit.

  • Subjects receiving or who are expected to receive Cyclosporine, mycophenolate, ortacrolimus within 4 weeks of the Day 1 study visit.

Study Design

Total Participants: 105
Study Start date:
February 01, 2011
Estimated Completion Date:
November 30, 2014

Connect with a study center

  • Hopital Erasme / Gastroenterology

    Brussels, 1070
    Belgium

    Site Not Available

  • Pfizer Clinical Research Unit

    Bruxelles, 1070
    Belgium

    Site Not Available

  • Northern Alberta Clinical Trials and Research Center

    Edmonton, Alberta T6G 2C8
    Canada

    Site Not Available

  • University of Alberta Hospital

    Edmonton, Alberta T6G 2B7
    Canada

    Site Not Available

  • Zeidler Ledcor Centre - University of Alberta

    Edmonton, Alberta T6G 2X8
    Canada

    Site Not Available

  • Pfizer Investigational Site

    London, Ontario N6A 5A5
    Canada

    Site Not Available

  • Maisonneuve-Rosemont Hospital

    Montreal, Quebec H1T 2M4
    Canada

    Site Not Available

  • Agaplesion Markus Krankenhaus

    Frankfurt am Main, 60431
    Germany

    Site Not Available

  • Universitaetsklinikum Halle

    Halle, 06120
    Germany

    Site Not Available

  • Medizinische Hochschule Hannover

    Hannover, 30625
    Germany

    Site Not Available

  • Pfizer Investigational Site

    Muenster, 48149
    Germany

    Site Not Available

  • Pfizer Investigational Site

    Ulm, 89081
    Germany

    Site Not Available

  • Szent Janos Korhaz es Eszak-budai Egyesitett Korhazak/I. Belgyogyaszat es Gastroenterologia

    Budapest, 1125
    Hungary

    Site Not Available

  • Pfizer Investigational Site

    Gyor, 9023
    Hungary

    Site Not Available

  • Pandy Kalman Megyei Korhaz, III. sz. Belosztaly-Gasztroenterologia

    Gyula, 5700
    Hungary

    Site Not Available

  • Karolina Korhaz Rendelointezet, Belgyogyaszat

    Mosonmagyarovar, 9200
    Hungary

    Site Not Available

  • Tolna Megyei Balassa Janos Korhaz / II. Belgyogyaszat

    Szekszard, 7100
    Hungary

    Site Not Available

  • Pfizer Investigational Site

    Rozzano, Milano 20089
    Italy

    Site Not Available

  • Azienda Ospedaliera Luigi Sacco

    Milano, 20157
    Italy

    Site Not Available

  • Azienda Ospedaliera di Padova

    Padova, 35128
    Italy

    Site Not Available

  • Policlinico Universitario Agostino Gemelli

    Roma, 00168
    Italy

    Site Not Available

  • Gastroenterologicke a hepatologicke oddelenie, V. interna klinika LFUK a UN Bratislava, Ruzinov

    Bratislava, 826 06
    Slovakia

    Site Not Available

  • Pfizer Investigational Site

    Nitra, 94901
    Slovakia

    Site Not Available

  • Gastroenterologicka ambulancia, GEA s.r.o.

    Trnava, 917 01
    Slovakia

    Site Not Available

  • Sahlgrenska Universitetssjukhuset Medicinkliniken

    Goteborg, 413 45
    Sweden

    Site Not Available

  • Karolinska Universitetssjukhuset, GastroCentrum Medicin

    Stockholm, 171 76
    Sweden

    Site Not Available

  • Akademiska sjukhuset, Mag tarmmottagningen

    Uppsala, 751 85
    Sweden

    Site Not Available

  • USCF Endoscopy Unit at Mount Zion

    San Francisco, California 94115
    United States

    Site Not Available

  • University of California San Francisco

    San Francisco, California 94115
    United States

    Site Not Available

  • Clinical Research of the Rockies

    Lafayette, Colorado 80026
    United States

    Site Not Available

  • Rocky Mountain Gastroenterology Associates, LLC

    Lakewood, Colorado 80215
    United States

    Site Not Available

  • Arapahoe Gastroenterology, PC

    Littleton, Colorado 80120
    United States

    Site Not Available

  • Metropolitan Gastroenterology Group, PC

    Washington, District of Columbia 20006
    United States

    Site Not Available

  • Clinical Research of West Florida, Inc.

    Clearwater, Florida 33765
    United States

    Site Not Available

  • Gastroenterology Consultants of Clearwater

    Clearwater, Florida 33756
    United States

    Site Not Available

  • West Coast Endoscopy Center

    Clearwater, Florida 33756
    United States

    Site Not Available

  • Borland-Groover Clinic

    Jacksonville, Florida 32256
    United States

    Site Not Available

  • Jacksonville Center for Endoscopy

    Jacksonville, Florida 32256
    United States

    Site Not Available

  • Pfizer Investigational Site

    New Port Richey, Florida 34652
    United States

    Site Not Available

  • Miami Research Associates

    South Miami, Florida 33143
    United States

    Site Not Available

  • Pfizer Investigational Site

    Trinity, Florida 34655
    United States

    Site Not Available

  • University of Chicago Medical Center

    Chicago, Illinois 60637
    United States

    Site Not Available

  • Cotton-O'Neil Clinical Research Center, Digestive Health

    Topeka, Kansas 66606
    United States

    Site Not Available

  • University of Louisville Healthcare Outpatient Center

    Louisville, Kentucky 40202
    United States

    Site Not Available

  • University of Louisville Hospital

    Louisville, Kentucky 40202
    United States

    Site Not Available

  • Pfizer Investigational Site

    Annapolis, Maryland 21401
    United States

    Site Not Available

  • Metropolitan Gastroenterology Group, PC - Chevy Chase Clinical Research

    Chevy Chase, Maryland 20815
    United States

    Site Not Available

  • Pfizer Investigational Site

    Hollywood, Maryland 20636
    United States

    Site Not Available

  • Endoscopic Microsurgery Associates, PA

    Towson, Maryland 21204
    United States

    Site Not Available

  • Clinical Research Institute of Michigan, LLC

    Chesterfield, Michigan 48047
    United States

    Site Not Available

  • Pfizer Investigational Site

    Detroit, Michigan 48202
    United States

    Site Not Available

  • Pfizer Investigational Site

    Novi, Michigan 48377
    United States

    Site Not Available

  • Center for Digestive Health

    Troy, Michigan 48098
    United States

    Site Not Available

  • Utica Surgery Center

    Utica, Michigan 48317
    United States

    Site Not Available

  • Pfizer Investigational Site

    West Bloomfield, Michigan 48322
    United States

    Site Not Available

  • Surgery Center of Columbia

    Columbia, Missouri 65201
    United States

    Site Not Available

  • Center for Digestive and Liver Diseases, Inc.

    Mexico, Missouri 65265
    United States

    Site Not Available

  • Asher Kornbluth, MD PC

    New York, New York 10128
    United States

    Site Not Available

  • Mount Sinai School of Medicine

    New York, New York 10029
    United States

    Site Not Available

  • Present, Chapman, Steinlauf and Marion

    New York, New York 10028
    United States

    Site Not Available

  • Charlotte Gastroenterology and Hepatology, PLLC

    Charlotte, North Carolina 28207
    United States

    Site Not Available

  • Wake Internal Medicine Consultants, Inc.

    Raleigh, North Carolina 27612
    United States

    Site Not Available

  • Wake Research Associates

    Raleigh, North Carolina 27612
    United States

    Site Not Available

  • Wake Forest University University Baptist Medical Center - Internal Medicine

    Winston Salem, North Carolina 27157
    United States

    Site Not Available

  • Gastro One

    Germantown, Tennessee 38138
    United States

    Site Not Available

  • Vanderbilt University Medical Center

    Nashville, Tennessee 37232-1375
    United States

    Site Not Available

  • Digestive and Liver Disease Specialists

    Norfolk, Virginia 23502
    United States

    Site Not Available

  • Sentara Leigh Hospital

    Norfolk, Virginia 23502
    United States

    Site Not Available

  • Sentara Norfolk General Hospital

    Norfolk, Virginia 23507
    United States

    Site Not Available

  • McGuire DVAMC

    Richmond, Virginia 23249
    United States

    Site Not Available

  • University of Washington Medical Center

    Seattle, Washington 98195
    United States

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.