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

NCT01240915

Last updated date
Study Location
University of California San Francisco
San Francisco, California, 94115, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Ulcerative Colitis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Subjects must have a documented diagnosis of ulcerative colitis at least 6 months prior 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 7 days of first dosing.

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

- Subjects must be on stable steroid doses.

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- Subjects who have abnormal organ and marrow function.


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


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


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


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

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Pfizer Clinical Trials Contact Center

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Advanced Information
Descriptive Information
Brief Title  ICMJE A Study To Investigate The Safety And Possible Clinical Benefit Of Multistem(r) In Patients With Moderate To Severe Ulcerative Colitis
Official Title  ICMJE A Phase 2 Randomized, Double-blind, Placebo-controlled, Parallel Group, Multi-center Study To Investigate The Safety And Efficacy Of Multistem (Pf-05285401) In Subjects With Moderate To Severe Ulcerative Colitis
Brief 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Colitis, Ulcerative
Intervention  ICMJE
  • Drug: placebo
    once every 7 days for 1- 3 doses
  • Drug: MultiStem low dose
    1-3 doses
  • Drug: placebo
    Single dose at week 8
  • Drug: MultiStem low dose
    Single dose at week 8
  • Drug: placebo
    Single dose Day 1
  • Drug: MultiStem high dose
    Single dose Day 1
  • Drug: MultiStem high dose
    Single dose at week 8
Study Arms  ICMJE
  • Experimental: Cohort 1
    The first 9 subjects will be recruited into Cohort 1 and will receive either placebo (n=3) or MultiStem low dose (n=6) as an intravenous infusion on Day 1. The first five patients enrolled constitute a subgroup of Cohort 1 and these patients will receive multiple doses, once every day for 7 days for 3 doses (Day 1 and Weeks 1 & 2).
    Interventions:
    • Drug: placebo
    • Drug: MultiStem low dose
    • Drug: placebo
    • Drug: MultiStem low dose
  • Experimental: Cohort 2
    This group will receive either placebo (n=3) or MultiStem high dose (n=6) as an intravenous infusion on Day 1. The subjects then receive the opposite dose of study medication at Week 8.
    Interventions:
    • Drug: placebo
    • Drug: MultiStem high dose
    • Drug: placebo
    • Drug: MultiStem high dose
  • Experimental: Cohort 3
    These subjects (total n=88 evaluable patients) will receive either Placebo or MultiStem (1:1 randomization) as an intravenous infusion on Day 1. In addition all subjects in Cohort 3 will receive a single infusion of either MultiStem or Placebo at Week 8, depending on their randomization schedule. A total of ~22 patients will receive an additional infusion of MultiStem, ~44 patients will receive the alternative blinded therapy to that which they received for Day 1 infusion, and ~22 patients will receive an additional infusion of placebo.
    Interventions:
    • Drug: placebo
    • Drug: MultiStem high dose
    • Drug: placebo
    • Drug: MultiStem high dose
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 26, 2016)
105
Original Estimated Enrollment  ICMJE
 (submitted: November 10, 2010)
126
Actual Study Completion Date  ICMJE November 2014
Actual Primary Completion Date November 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Subjects must have a documented diagnosis of ulcerative colitis at least 6 months prior 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 7 days of first dosing.
  • Subjects must have failed or be intolerant (as determined by the investigator) of at least one of the following treatments for UC: Oral corticosteroids, azathioprine or 6-mercaptopurine (6-MP), or anti-tumor necrosis factor (TNF) therapy, eg, infliximab or adalimumab.
  • Subjects must be on stable steroid doses.

Exclusion Criteria:

  • Subjects who have abnormal organ and marrow function.
  • Subjects with a diagnosis of indeterminate colitis, or clinical findings suggestive of Crohn's disease.
  • Subjects who meet Truelove-Witts criteria for severe ulcerative colitis.
  • Subjects receiving or who are expected to receive Infliximab or other biologic treatment within 8 weeks of the Day 1 study visit.
  • Subjects receiving or who are expected to receive Cyclosporine, mycophenolate, or tacrolimus within 4 weeks of the Day 1 study visit.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium,   Canada,   Germany,   Hungary,   Italy,   Slovakia,   Sweden,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01240915
Other Study ID Numbers  ICMJE B3041001
2010-022766-27 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Athersys, Inc
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date January 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP