Interim analysis results from the RESTORE-CLI, a randomized, double-blind multicenter phase II trial comparing expanded autologous bone marrow-derived.

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Presentation transcript:

Interim analysis results from the RESTORE-CLI, a randomized, double-blind multicenter phase II trial comparing expanded autologous bone marrow-derived tissue repair cells and placebo in patients with critical limb ischemia Richard J. Powell, MD, Anthony J. Comerota, MD, Scott A. Berceli, MD, Raul Guzman, MD, Timothy D. Henry, MD, Edith Tzeng, MD, Omaida Velazquez, MD, William A. Marston, MD, Ronnda L. Bartel, PhD, Amy Longcore, MS, Theresa Stern, PhD, Sharon Watling, PhD Journal of Vascular Surgery Volume 54, Issue 4, Pages 1032-1041 (October 2011) DOI: 10.1016/j.jvs.2011.04.006 Copyright © 2011 Society for Vascular Surgery Terms and Conditions

Fig 1 Patient flow diagram (based on interim analysis data up to November 2009). Journal of Vascular Surgery 2011 54, 1032-1041DOI: (10.1016/j.jvs.2011.04.006) Copyright © 2011 Society for Vascular Surgery Terms and Conditions

Fig 2 Phenotypic analysis of bone marrow aspirate and tissue repair cell (TRC) product samples. Flow cytometric analysis was performed on aspirate samples before automated single-pass perfusion culture and on the TRC products. Patients that had samples with complete phenotypic analyses for both aspirate and TRC samples were included (n = 19). Figures above the bars indicate the average number of cells in millions. Journal of Vascular Surgery 2011 54, 1032-1041DOI: (10.1016/j.jvs.2011.04.006) Copyright © 2011 Society for Vascular Surgery Terms and Conditions

Fig 3 Kaplan-Meier survival plot of time to first occurrence of treatment failure, a composite end point of major amputation, doubling of wound total surface area, occurrence of de novo gangrene, or death. Most events occurred in control group patients within the first 100 days; median time to treatment failure was 60 days with 3 of 14 patients censored for the analysis. In the tissue repair cell (TRC)-treated group, the median time to treatment failure was not reached, with 19 of 32 patients censored for the analysis. Censored observations are indicated by “+” symbols. Number of subjects at risk in the TRC-treated group were 32 at day 0 and 26 at day 100 and 16 at day 200 and 13 at day 300. Number of subjects at risk in the control group were 14 at day 0 and 5 at day 100 and 4 at day 200 and 2 at day 300. Journal of Vascular Surgery 2011 54, 1032-1041DOI: (10.1016/j.jvs.2011.04.006) Copyright © 2011 Society for Vascular Surgery Terms and Conditions

Fig 4 Kaplan-Meier survival plot of amputation-free survival. Most events occurred in control group patients within the first 50 days; median time to treatment failure was not reached, with 7 of 14 patients censored for the analysis. In the tissue repair cell (TRC)-treated group, the median time to treatment failure was not reached, with 25 of 32 patients censored for the analysis. Censored observations are indicated by “+” symbols. Number of subjects at risk in the TRC-treated group were 32 at day 0 and 29 at day 100 and 20 at day 200 and 16 at day 300. Number of subjects at risk in the control group were 14 at day 0 and 8 at day 100 and 8 at day 200 and 6 at day 300. Journal of Vascular Surgery 2011 54, 1032-1041DOI: (10.1016/j.jvs.2011.04.006) Copyright © 2011 Society for Vascular Surgery Terms and Conditions

Fig 5 Complete wound healing rate in patients completing 12-months of follow-up at 6- and 12-month time points. There was no statistical difference between control and tissue repair cell (TRC)-patient groups at the 6-month time point (P = 1.00, Fisher exact test). At the 12-month time point, the greater incidence of wound healing in the TRC-treated group was also not statistically significant, due to the small sample size (P = .61, Fisher exact test). Journal of Vascular Surgery 2011 54, 1032-1041DOI: (10.1016/j.jvs.2011.04.006) Copyright © 2011 Society for Vascular Surgery Terms and Conditions