A Study To Investigate The Safety And Possible Clinical Benefit Of Multistem(r) In Patients With Moderate To Severe Ulcerative Colitis
Condition: Colitis, Ulcerative
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Intervention: placebo; MultiStem low dose; placebo; MultiStem low dose; placebo; MultiStem high dose; placebo; MultiStem high dose; placebo; MultiStem high dose; placebo; MultiStem high dose
Intervention description: once every 7 days for 1- 3 doses; 1-3 doses; Single dose at week 8; Single dose at week 8; Single dose Day 1; Single dose Day 1; Single dose at week 8; Single dose at week 8; Single dose Day 1; Single dose Day 1; Single dose at week 8; Single dose at week 8
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 105.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: safety efficacy MultiStem(r) 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.
    

Eligibility criteria:

        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.