Enhancing Limb Salvage by Non-Mobilized Peripheral Blood Angiogenic Cell Precursors Therapy in Patients with Critical Limb Ischemia
Summary: This Phase I/II trial (n=18 CLI patients, Rutherford 4-5, no revascularization options) evaluated intramuscular injection of non-mobilized autologous peripheral blood angiogenic cell precursors (PB-ACPs, CD34+/VEGFR2+). PB-ACPs were isolated via apheresis (no G-CSF mobilization), yielding 1.2×10^7 cells/patient. At 12 months, 75% achieved limb salvage (vs historical 50%), with 44% wound healing and 61% pain reduction. No major AEs; TcPO2 ↑ 15 mmHg, ABI ↑ 0.15. Demonstrates feasibility/safety of non-mobilized PB-ACPs for CLI-related wounds, bypassing mobilization toxicities; larger RCTs needed for efficacy.
Key Highlights:
- Population: 18 CLI patients; 61% DFU; mean age 71.
- Outcomes: 75% limb salvage; 44% wound healing; 61% ↓ pain (VAS).
- Hemodynamics: TcPO2 ↑ 15 mmHg; ABI ↑ 0.15; collateral ↑ on angiography.
- Safety: No AEs; 1.2×10^7 cells injected IM (20 sites).
- Authors: Losordo DW, Kibbe MR, Mendelsohn FO et al.
Keywords: PB-ACPs, CLI, limb salvage, autologous therapy, phase II, DW Losordo, MR Kibbe, FO Mendelsohn