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

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

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

Sponsors & Collaborators

• Healios K.K.

  collaborator INDUSTRY

• Pfizer

  lead INDUSTRY

Principal Investigators

• Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2011-02-28

Primary Completion

2014-11-30

Completion

2014-11-30

Countries

• United States
• Belgium
• Canada
• Germany
• Hungary
• Italy
• Slovakia
• Sweden

Study Locations