Cyclic strain of adult stem cells modulates matrix metalloproteinase activity: Mechanism for promoting cell-based cardiac remodeling

within six weeks of transplantation and given in addition to systemic immunosuppression. A total of 56 patients received either 300 mg of CyIS (n 26) or aerosol placebo (n 30) three days a week for up to 2 years. Analysis of survival duration through study completion (August 21, 2003) has been previously presented, showing a statistically significant and clinically relevant reduction in mortality on the CyIS arm relative to the placebo (Hazard Ratio 0.213). To evaluate the persistence of the survival benefit observed with CyIS, post-study follow-up data has been collected through June 2004 on all randomized subjects. At the time of the August 2003 cut-off date, median survival was 39.9 months for the Placebo group, but was not estimable for the CyIS group since too few deaths had occurred. With the inclusion of the follow-up data through June 2004, median survival for the Placebo group was 51.4 months, while median survival was still not estimable for the CyIS group. The 51.4-month survival rate of 77% for the CyIS group demonstrates a clinically meaningful effect of CyIS that persists more than two years after the cessation of dosing. This study was funded by NIH Grant HL05949001. Data analyses were performed by Chiron Corporation.