1 | 2 | 3 | 4 | 5 | 6 | 7 | |
---|---|---|---|---|---|---|---|
Patients characteristics | |||||||
Age (years) | 74 | 57 | 52 | 57 | 74 | 62 | 42 |
Gender (M: male; F: female) | M | M | M | M | F | M | M |
BMI (kg/m2) | 27 | 25 | 26 | 32 | 20 | 22 | 21 |
Smoker | No | Past | Past | Past | No | Past | Current |
Arterial hypertension | Yes | Yes | No | No | No | Yes | No |
Hyperlipidemia | Yes | No | Yes | No | Yes | No | No |
Diabetes mellitus | Yes | No | Yes | No | No | No | No |
Disease characteristics | |||||||
TcPO2 (mmHg) | 26 | 30 | 64 | 35 | 45 | 1 | 7 |
Presence of ulcers | No | No | Yes | No | No | No | No |
Cardioprotective drugs usea | AT, ACEI | AT, ACEI, S | AT, ACEI, S | AT, ACEI, S | AT | AT, S | AT, S |
BMC characterization | |||||||
PLTs (G/L) | 746 | 740 | 478 | 590 | 384 | 1296 | 1118 |
Total nucleated cells (G/L): | 47 | 60 | 38 | 48 | 50 | 76 | 71 |
Total MNCs | |||||||
Lymphocytes (%) | 46 | 47 | 39 | 41 | 48 | 46 | 54 |
Monocytes (%) | 18 | 12 | 28 | 18 | 19 | 14 | 13 |
Erythroblasts and other cells (%)b | 10.5 | 14.3 | 10.4 | 19.8 | 12.7 | 13.2 | 14.5 |
Mature granulocytes (%) | 23 | 23 | 18 | 16 | 17 | 23 | 16 |
HSCs (CD34+ cells) (%) | 2.5 | 3.7 | 4.6 | 5.2 | 3.3 | 3.8 | 2.5 |
MSCsc | 42 | 38 | 34 | 58 | 28 | 12 | 60 |
Placebo or BMCs group | BMCs | BMCs | Placebo | Placebo | BMCs | BMCs | Placebo |
Clinical outcome at 6 months | ∅ | ∅ | ∅ | ∅ | ∅ | Revascularization at day 126 | Major amputation at day 114 |
Clinical outcome at 12 months | Revascularization at day 332 | ∅ | ∅ | ∅ | ∅ |