PACE
Trial question
What is the role of placenta-derived mesenchymal stromal-like cell (PLX-PAD) therapy in patients with chronic limb-threatening ischemia unsuitable for revascularization?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
24.0% female
76.0% male
N = 213
213 patients (51 female, 162 male).
Inclusion criteria: patients with chronic limb-threatening ischemia and minor tissue loss unsuitable for revascularization.
Key exclusion criteria: non-atherosclerotic peripheral arterial disease; major tissue loss; infection; planned amputation; insufficient arterial inflow to the index leg; HbA1c level ≥ 10%; or an estimated life expectancy < 6 months.
Interventions
N=143 PLX-PAD (cryogenic vials containing placental-expanded mesenchymal stromal-like cells, 10% dimethyl sulphoxide, 5% human serum albumin, and Plasma-Lyte with 30 IM injections of 0.5 mL each into the index leg on days 0 and 60).
N=70 placebo (identical vials containing 10% dimethyl sulphoxide, 5% human serum albumin, and Plasma-Lyte with 30 IM injections of 0.5 mL each into the index leg on days 0 and 60).
Primary outcome
Major amputation or death
33%
28.6%
33.0 %
24.8 %
16.5 %
8.3 %
0.0 %
PLX-PAD
Placebo
No significant
difference ↔
No significant difference in major amputation or death (33% vs. 28.6%; HR 0.93, 95% CI 0.53 to 1.63).
Safety outcomes
No significant difference in injection site reactions.
Conclusion
In patients with chronic limb-threatening ischemia and minor tissue loss unsuitable for revascularization, PLX-PAD was not superior to placebo with respect to major amputation or death.
Reference
Lars Norgren, Norbert Weiss, Sigrid Nikol et al. PACE: randomized, controlled, multicentre, multinational, phase III study of PLX-PAD for critical limb ischaemia in patients unsuitable for revascularization: randomized clinical trial. Br J Surg. 2024 Jan 31;111(2):znad437.
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