Results of a prospective observational study of autologous peripheral blood mononuclear cell therapy for no-option critical limb-threatening ischemia and severe diabetic foot ulcers

Table 3 Cellular and molecular characterization at enrollment, stratifying study population according to TcPO₂ levels after the last PB-MNCs treatment (< 40 mmHg; ≥ 40 mmHg)

	TcPO₂ levels		Comparison, p-value
	< 40 mmHg	≥ 40 mmHg	Comparison, p-value
N (%)	21 (42.0)	29 (58.0)	–
Age (years), mean ± SD	78.67 ± 8.78	72.69 ± 10.24	0.0522
Males, n (%)	12 (57.14)	19 (65.52)	0.5471
PB-MNCs treatments, n (%)
1	12 (57.14)	0 (0.00)	<0 .0001
2	1 (4.76)	10 (34.48)
3	8 (38.10)	19 (65.52)
TcPO₂, mean ± SD
At enrollment	16.48 ± 11.54	17.72 ± 11.74	0.5588
After the last PB-MNCs treatment	17.10 ± 12.20	55.07 ± 9.73	<0 .0001
PB cell frequency^*, mean ± SD
CD34⁺	0.26 ± 0.12	0.30 ± 0.21	0.7215
CD34⁺CXCR4⁺	40.56 ± 19.78	44.06 ± 11.48	0.2880
EVs^‡, mean ± SD
EV size (nm)	195.59 ± 29.74	136.31 ± 27.41	0.0001
Total EV concentration (ml × 10¹⁰)	3.50 ± 1.20	3.62 ± 1.72	0.9728
Small EV (30-100 nM) (%)	4.0 ± 5.0	33.0 ± 18.0	0.0012

EVs extracellular vesicles, PB peripheral blood, PB-MNCs peripheral blood mononuclear cells, SD standard deviation
^*CD34⁺ was not available for 5 patients (10%) s, CD34⁺CXCR4⁺ for 10 patients (20%). ‡ EV (30-100 nM) evaluation was performed on 22 patients (44%)
P-values < 0.05 are displayed in bold

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