Adipose-Derived Stromal Cells for Treatment of Patients with Chronic Ischemic Heart Disease (MyStromalCell Trial): A Randomized Placebo-Controlled Study
Table 1
Baseline characteristics.
Parameter
Placebo ()
ASC ()
value
Age (years)
65.3 ± 8.7
65.5 ± 9.7
0.94
Male gender
20 (100)
35 (87.5)
0.02
BMI (kg/m2)
30.0 ± 4.8
30.0 ± 4.1
0.92
Smoking
0.19
Current
3 (15)
8 (20)
Previous
16 (80)
23 (57.5)
Never
1 (5)
9 (22.5)
Diabetes mellitus
6 (30)
16 (40)
0.57
Hypertension
12 (60)
33 (82.5)
0.06
AMI
10 (50)
26 (65)
0.26
CABG
20 (100)
33 (82.5)
0.08
PCI
15 (75)
28 (70)
0.69
LVEF (%)
54 ± 8
52 ± 8
0.38
Systolic blood pressure (mmHg)
133 ± 19
132 ± 17
0.91
Diastolic blood pressure (mmHg)
76 ± 11
76 ± 12
0.99
Heart rate (beats/min)
66 ± 9
63 ± 7
0.14
FEV1 (L)
2.27 ± 0.61
2.34 ± 0.69
0.69
FVC (L)
3.17 ± 0.65
3.11 ± 0.80
0.76
FEV1/FVC
71.2 ± 10.3
74.8 ± 7.7
0.18
Pro-BNP (pmol/L)
30.4 ± 24.3
39.6 ± 37.5
0.27
TnT (ng/L)
12.5 ± 2.1
14.9 ± 7.8
0.09
CK-MB (μg/L)
2.8 ± 1.6
3.2 ± 1.4
0.36
Hgb A1c (mmol/L)
6.1 ± 0.6
6.7 ± 1.3
0.03
Total cholesterol (mmol/L)
3.8 ± 0.7
4.3 ± 1.2
0.06
HDL-C (mmol/L)
1.0 ± 0.2
1.2 ± 0.4
0.05
LDL-C (mmol/L)
1.9 ± 0.6
2.5 ± 1.0
0.02
Triglycerides (mmol/L)
2.6 ± 1.5
1.8 ± 0.8
0.06
CRP (mg/L)
5.0 ± 10.0
3.6 ± 3.7
0.57
Medication
Acetylsalicylic acid
19 (95)
35 (87.5)
0.65
Clopidogrel
7 (35)
11 (27.5)
0.56
ACE-I or ARB
13 (65)
29 (72.5)
0.42
β-Blocker
16 (80)
33 (82.5)
1.00
Calcium antagonist
12 (60)
19 (47.5)
0.42
Diuretics
12 (60)
27 (67.5)
0.58
Statins
20 (100)
40 (100)
1.00
Nitrate
19 (95)
28 (70)
0.04
Nicorandil
6 (30)
5 (12.5)
0.16
Ivabradine
2 (10)
4 (10)
1.00
ACE-I: angiotensin-converting enzyme inhibitor; AMI: acute myocardial infarction; ARB: angiotensin II receptor blockers; ASC: adipose-derived stromal cell; BMI: body mass index; CABG: coronary artery bypass grafting; CK-MB: creatine kinase MB; CRP: C-reactive protein; FEV1: forced expiratory volume in 1 s; FVC: forced vital capacity; HDL-C: high-density lipoprotein cholesterol; Hgb A1c: hemoglobin A1c; LDL: low-density lipoprotein cholesterol; LVEF: left ventricular ejection fraction; n: number of patients; PCI: percutaneous coronary intervention; Pro-BNP: probrain natriuretic peptide; TnT: troponin T.
