NCT00826046

Prochymal® Expanded Access for Adults Who Have Failed Steroid Treatment for Acute Graft Versus Host Disease (GVHD)

Expanded Access 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

• Status: No Longer Available
• Phase: —
• Study type: Expanded Access
• Enrollment: —
• Sponsor: Mesoblast, Inc. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: —

Summary

This protocol allows for the treatment of patients, male and female, between the ages of 18 years and 70 years. Patients must have failed to respond to steroid treatment for Grade C-D acute GVHD.

Detailed description

This is a treatment protocol to provide patients who have failed steroid treatment for acute GVHD expanded access of Prochymal. It is anticipated that a maximum of 10 patients per month for a total of 120 patients per year will be treated according to this protocol. Patients will be treated with Prochymal twice per week at a dose of 2 x 106 human mesenchymal stem cell (hMSC)/kg (actual body weight) for each of 4 consecutive weeks. Infusions will be administered at least 3 days apart.

Conditions

• Graft-Versus-Host Disease

Interventions

Type	Name	Description
DRUG	Prochymal®	Patients will be treated with Prochymal twice per week at a dose of 2 x 106 hMSC/kg (actual body weight) for each of 4 consecutive weeks. Infusions will be administered at least 3 days apart.

Timeline

• First posted: 2009-01-21
• Last updated: 2020-03-09

Locations

3 sites across 1 country: United States