Expanded Access of Prochymal Infusion for the Treatment of Pediatric Patients with Acute Refractory GVHD

Protocol
09-072
Full Title
Expanded Access of Prochymal (Ex-vivo Cultured Adult Human Mesenchymal Stem Cells) Infusion for the Treatment of Pediatric Patients who have Failed to Respond to Steroid Treatment for Acute GVHD
Phase
III
Purpose

About 60 percent of patients who have a stem cell transplant experience a complication called graft-versus-host disease (GVHD), in which cells from the donor attack tissues of the recipient. Symptoms of GVHD include rash, digestive problems, weight loss, and liver dysfunction.

GVHD is usually treated with corticosteroid drugs, but in some patients the condition persists despite this therapy. The purpose of this study is to evaluate the effectiveness of a novel treatment called Prochymal in children with GVHD of the skin, liver, and/or intestines that persists despite steroids.

Prochymal contains adult human mesenchymal stem cells, which may help repair tissues damaged by GVHD by suppressing the immune response that triggers this condition. Patients will receive Prochymal in addition to the standard care for GVHD.

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have GVHD that persists despite steroid treatment
  • Patients must be between the ages of 2 months and 17 years.
  • Patients may not be allergic to bovine or porcine products.

For more information and to inquire about eligibility for this study, please contact Dr. Susan Prockop at 212-639-6715.

Disease(s)
Blood and Marrow Transplantation: Transplantation
Locations