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- W4386892059 abstract "We report the results from a phase 2 clinical trial on autologous blood derived angiogenic cell precursors (ACP-01) to treat patients with no revascularization option critical limb ischemia (CLI). A randomized, double-blind, placebo-controlled trial was undertaken to assess ACP-01 therapy in patients with no option CLI (ACP-CLI). Patients were randomized 2:1 to receive treatment with ACP-01 or placebo by direct injection into the gastrocnemius muscle and foot of the affected limb. The primary endpoints were time to major amputation or death. Secondary endpoints were change in pain levels and ulcer size. Patients were followed for 1 year. From 2015 to 2021, 67 patients with no-option CLI were allocated to treatment (46/67) or placebo (21/67). There were no complications from treatment. Ulcers were present in 21 of 46 and eight of 21 of treated and placebo patients. The mean ulcer sizes were 1.6 and 1.8 cm2, respectively. At 3-month follow-up, the mean ulcer area was 0.75 mm3 in the treatment group and 4.04 mm3 in the placebo group. Change in visual analogue pain scores between the two groups was similar. Major (all below-knee) amputations occurred in three of 46 (6.5%) of the treated group and two of 21 (9.5%) of the placebo group (P = NS). After 1 year follow-up, death unrelated to treatment occurred in six patients, five of 46 (10.9%) of the treated group and one of 21 (4.8%) of the placebo group (P = NS). The mean time from administration of treatment or placebo to amputation or death was not different. In this underpowered study of no-option patients with CLI, the application of ACP-01 was safe. Trends were seen in reductions in ulcer size and amputations but not pain scores or death. Given the safety of this treatment and reduction in ulcer size and major amputations in patients who received treatment, further properly powered studies are needed." @default.
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- W4386892059 date "2023-10-01" @default.
- W4386892059 modified "2023-09-27" @default.
- W4386892059 title "Report From a Phase 2 Prospective Randomized Placebo-controlled Trial of Autologous Stem Cells to Treat Patients With No Option Critical Limb Ischemia: The ACP CLI Trial" @default.
- W4386892059 doi "https://doi.org/10.1016/j.jvs.2023.08.075" @default.
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