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Prochymal in treatment-refractory acute GVHD
NCT00284986Phase 2
Key facts
- Status
- Completed
- Start
- Nov 2005
- Primary completion
- Apr 2006
- Countries
- 1
- Sponsor
- Mesoblast Ltd
- Modality
- Stem Cell Therapies
- Drugs
- remestemcel-L-rknd
- Conditions
- graft-versus-host disease (GVHD)
01
Overview
Phase 2, open-label, single-arm trial of remestemcel-L-rknd in graft-versus-host disease (GVHD), sponsored by Mesoblast Ltd. Primary endpoint: Response by Day 28. Started Nov 2005; status: completed.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
PROCHYMAL™
Single arm receiving Prochymal (ex-vivo cultured adult human mesenchymal stem cells) via intravenous infusion
03
Who it enrols
Patients aged 6 months to 70 years with Grade III-IV acute GVHD refractory to standard first-line and at least one second-line therapy, with creatinine clearance >30 mL/min
04
Endpoints
Primary
Response by Day 28
Secondary
Improvement of GVHD by Day 28 in one or more organs involved with GVHD symptoms at day 1
Best stage of each involved organ by Day 28
Time to improvement or resolution of GVHD in one or more organs
Adverse Events
Infusional Toxicity
Overall relapse of underlying disease
Overall Survival
Formation of ectopic tissue foci
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