Prochymal Clinical Trial Information for the Treatment of Acute GvHD
Enrollment for this trial has been completed.
The objective of this Phase II study was to evaluate the safety and efficacy of two dose levels of Prochymal plus standard steroid therapy. Patients were given two doses of Prochymal, three days apart at the onset of newly diagnosed acute GvHD, grades II-IV.
Trial Overview
Thirty two patients were enrolled in the trial. Male and female patients were eligible and must have been between the ages of 18 and 65. Patients must have received an allogeneic hemotopoietic stem cell transplant and must not have previously received treatment for graft versus host disease.
Trial Highlights
- 94% of evaluable patients responded after receiving two infusions of Prochymal
- 74% of evaluable patients achieved a complete response (meaning that the patients had experienced total clinical resolution of the disease)
- Patients experiencing a complete response rate by day 28 had a statistically significant improvement in survival as compared to patients experiencing a partial or non-response
- Prochymal appears to be well tolerated
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here to read more about the Phase II results.