NCT01240915

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 105 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Colitis, Ulcerative

Interventions

Type	Name	Description
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	placebo	Single dose at week 8
DRUG	MultiStem high dose	Single dose at week 8
DRUG	placebo	Single dose Day 1
DRUG	MultiStem high dose	Single dose Day 1
DRUG	placebo	Single dose at week 8
DRUG	MultiStem high dose	Single dose at week 8

Timeline

• Start date: 2011-02-01
• Primary completion: 2014-11-01
• Completion: 2014-11-01
• First posted: 2010-11-15
• Last updated: 2016-02-23
• Results posted: 2016-02-23

Locations

58 sites across 8 countries: United States, Belgium, Canada, Germany, Hungary, Italy, Slovakia, Sweden