You are here

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

Last updated on May 9, 2018

FOR MORE INFORMATION
Study Location
University of California San Francisco
San Francisco, California, 94115 United States
Contact
1-800-718-1021
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.

NCT01240915
Pfizer
Completed
A Study To Investigate The Safety And Possible Clinical Benefit Of Multistem(r) In Patients With Moderate To Severe Ulcerative Colitis

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

call now

Try a new search

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your zip code, city, or country to find studies near you.

Similar Trials

Ulcerative Colitis
NCT01470612
All Genders
18+
Years
Multiple Sites
Inflammatory Bowel Diseases, Ulcerative Colitis, Crohn's Disease
NCT02539368
All Genders
18+
Years
Multiple Sites
Ulcerative Colitis, Inflammatory Bowel Disease
NCT00038922
All Genders
A Study To Investigate The Safety And Possible Clinical Benefit Of Multistem(r) In Patients With Moderate To Severe Ulcerative Colitis
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
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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Colitis, Ulcerative
  • 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
  • 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
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
105
November 2014
November 2014   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Belgium,   Canada,   Germany,   Hungary,   Italy,   Slovakia,   Sweden,   United States
 
 
NCT01240915
B3041001
2010-022766-27 ( EudraCT Number )
Yes
Not Provided
Not Provided
Pfizer
Pfizer
Athersys, Inc
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
January 2016

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



Call Now