Clinical trial
Efficacy and Safety of Adult Human Mesenchymal Stem Cells to Treat Steroid…
NCT00366145 · Mesoblast, Inc., Industry · Completed
Key facts
| NCT number | NCT00366145 |
|---|---|
| Title | Efficacy and Safety of Adult Human Mesenchymal Stem Cells to Treat Steroid Refractory Acute Graft Versus Host Disease (GVHD) |
| Official title | A Phase III, Randomized, Double Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Prochymal® (Ex-vivo Cultured Adult Human Mesenchymal Stem Cells) Infusion for the Treatment of Patients Who Have Failed to Respond to Steroid Treatment for Acute GVHD |
| Lead sponsor | Mesoblast, Inc., Industry |
| Status | Completed |
| Phase | Phase 3 |
| Study type | Interventional |
| Conditions | Graft Versus Host Disease |
| Intervention type | Biological, Drug |
| Interventions | Prochymal®, Placebo, Standard of Care for GVHD |
| Enrollment | 260 |
| Start date | Aug 17, 2006 |
| Primary completion | Dec 26, 2008 |
| Completion | May 28, 2009 |
| First posted | Aug 21, 2006 |
| Last update posted | Feb 10, 2022 |
| Countries | Australia, Canada, Italy, Switzerland, United Kingdom, United States |
At a glance
- 10–99 Study sites
- No Results posted
- None Linked FDA submissions
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
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Source: U.S. National Library of Medicine (NLM), ClinicalTrials.gov · Source date: