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.
Timeline
- Start
- 2011-02
- Primary completion
- 2014-11
- Completion
- 2014-11
Outcome
Missed primary endpoint
registry analysis (superiority or other test); Pooled MultiStem vs Pooled Placebo; p = 0.96 NCT01240915 ↗
registry analysis (superiority or other test); Pooled MultiStem vs Pooled Placebo; p = 0.54 NCT01240915 ↗
registry analysis (superiority or other test); Pooled MultiStem vs Pooled Placebo; p = 0.67 NCT01240915 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | MultiStem | Cell therapy | — | Intravenous |