Graft-Versus-Host Disease Clinical Trial
Official title:
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
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.
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.
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