Adipose-Derived Stromal Cells for Treatment of Patients with Chronic Ischemic Heart Disease (MyStromalCell Trial): A Randomized Placebo-Controlled Study
Table 2
(a) Serious adverse events after NOGA mapping and injections in the placebo and adipose-derived stromal cell (ASC) group. (b) Number of patients with one or more SAE/AE(s) in patients treated with placebo or ASCs.
(a)
Serious adverse events
Placebo ()
ASC ()
value
Death
0 (0)
1 (2.5)
1.00
Hospitalizations
Myocardial infarction
1 (5)
1 (2.5)
1.00
Dyspnea
0 (0)
1 (2.5)
1.00
Anemia
1 (5)
1 (2.5)
1.00
Syncope
1 (5)
0 (0)
0.33
Peripheral edema
0 (0)
1 (2.5)
1.00
Angina worsening
3 (15)
6 (15)
1.00
Pneumonia
1 (5)
1 (2.5)
1.00
NOGA-related complications
Pericardial effusion
0 (0)
1 (2.5)
1.00
ECG changes—SA-block, NsVT
2 (10)
1 (2.5)
0.26
Hematoma at femoral puncture
1 (5)
0 (0)
0.33
Allergic reaction
0 (0)
1 (2.5)
1.00
Bradycardia
0 (0)
1 (2.5)
1.00
General discomfort
0 (0)
1 (2.5)
1.00
NsVT: nonsustained ventricular tachycardia; SA-block: sinoatrial block. Values are n (%); values are calculated using Fischer’s exact test.
(b)
Placebo ()
ASC ()
value
Major adverse events
4 (20)
9 (22.5)
1.00
Nonmajor adverse events
4 (20)
4 (10)
0.42
Values are n (%); values are calculated using Fischer’s exact test.
