This was a large study enrolling 244 patients. Most patients have advanced GVHD; IBMTR severity index grade for Prochymal vs. placebo treated patients was B in 22 vs. 26%, C in 51 vs. 58%, and D in 27% vs. 16%. The groups were well matched and randomized in a 2: 1 fashion. Although the intention to treat analysis showed no difference in durable complete response (DCR) rates (35 vs. 30%, P 5 0.3), there was a trend toward better DCR in the treated population at 40% vs. 28% (P 5 0.08). For the 22 patients with involvement of three organs, the rate of CR/PR at day 28 was 63% for the treatment group compared to 0% for the placebo group (P < 0.05). Importantly there was no significant difference in infections, relapse (9% vs. 8%) or adverse events.