NCT00284986

Safety and Efficacy of Prochymal for the Salvage of Treatment-Refractory Acute GVHD Participants

A Phase II Open Label Study to Evaluate the Safety and Efficacy of Prochymal (Ex-vivo Cultured Adult Human Mesenchymal Stem Cells) Infusion for the Salvage of Treatment-Refractory Acute GVHD Patients

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: Mesoblast, Inc. · Industry
• Sex: All
• Age: 6 Months – 70 Years
• Healthy volunteers: Not accepted

Summary

This study is designed to evaluate the safety and efficacy of Prochymal® (Ex-vivo Cultured Adult Human Mesenchymal Stem Cells) in participants experiencing treatment-refractory acute GVHD, Grades III-IV, that is refractory to standard first-line therapies and at least one second-line therapy.

Detailed description

Allogeneic HSCT is used in the treatment of a variety of hematological, myeloproliferative and lymphoproliferative disorders, and malignancies involving solid tumors. Participants receiving HSCT can develop a life-threatening condition called GVHD. GVHD occurs when donor T cells from the donor bone marrow recognize host cells as "foreign" and initiate an inflammatory immunological response. The standard of care for treatment of acute GVHD consists of intravenous delivery of methylprednisolone starting on Day 1 and continuation of either cyclosporine or tacrolimus. This regimen of steroids and immunosuppressive drugs may relieve symptoms of GVHD, but some participants are refractory to current standard of care treatment. For treatment-refractory participants with grades III-IV GVHD mortality is approximately 80%. A therapy that could effectively suppress the immunological response from GVHD and help repair the damaged tissue could significantly decrease the mortality rate from this disease.

Conditions

• Graft Versus Host Disease

Interventions

Type	Name	Description
DRUG	Prochymal	Intravenous infusion of ex-vivo cultured adult human mesenchymal stem cells

Timeline

• Start date: 2005-11-18
• Primary completion: 2006-04-25
• Completion: 2007-02-08
• First posted: 2006-02-01
• Last updated: 2025-10-30

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study