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

Last updated on March 14, 2019

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.
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- 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

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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

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FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

Call Now