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©The Author(s) 2024.
World J Cardiol. Aug 26, 2024; 16(8): 469-483
Published online Aug 26, 2024. doi: 10.4330/wjc.v16.i8.469
Published online Aug 26, 2024. doi: 10.4330/wjc.v16.i8.469
Table 1 Baseline characteristics of randomized clinical trials included in the meta-analysis for mortality in umbilical-cord-derived mesenchymal-stem-cell-based heart therapy, n (%)
Gao et al[21], 2015 (China) | He et al[18], 2020 (China) | Zhao et al[26], 2015 (China) | Bartolucci et al[28], 2017 (Chile) | Ulus et al[25], 2020 (Türkiye) | ||
Study type | RCT | RCT | RCT | RCT | Open-label RCT | |
Phase | I/II | I | I/II | I/II | I/II | |
Sample size | Total | 116 | 50 | 59 | 30 | 41 |
Intervention (male) | 58 (94.8) | 32 (78.12) | 30 (80.0) | 15 (80.0) | 25 (100) | |
Control (male) | 58 (87.9) | 12 (58.30) | 29 (65.5) | 15 (93.3) | 16 (100) | |
Mean age (mean ± SD) | Intervention | 57.3 ± 9.90 | 59.6 (7.9)/63.6 (8.6) | 52.90 ± 16.32 | 57.33 ± 10.05 | 61.8 ± 10 |
Control | 56.7 ± 12.95 | 65.2 (7.9) | 53.21 ± 11.46 | 57.20 ± 11.64 | 65.3 ± 6.8 | |
Mean BMI (mean ± SD) | Intervention | 24.9 ± 2.28 | 25.5 ± 3.3 /24.4 ± 3.3 | N/A | 29.12 ± 2.88 | 26.5 ± 4.5 |
Control | 25.4 ± 2.28 | 23.59 ± 2.28 | N/A | 29.52 ± 4.00 | 26.6 ± 4.8 | |
Number of smokers | Intervention | 34 (58.6) | 4 (25.0)/7 (43.8) | N/A | 7 (46.7) | 21 (84) |
Control | 32 (55.2) | 3 (25.0) | N/A | 4 (26.7) | 15 (88.2) | |
HTN | Intervention | 33 (56.9) | 10 (62.5)/14 (87.5) | N/A | 7 (46.7) | 15 (60) |
Control | 26 (44.8) | 9 (75.0) | N/A | 8 (53.3) | 11 (64.7) | |
DM | Intervention | 17 (29.3) | 8 (50.0)/4 (25.0) | N/A | 5 (33.3) | 16 (66.7) |
Control | 14 (24.1) | 8 (66.7) | N/A | 7 (46.7) | 9 (52.9) | |
NYHA; I (n), II (n), III (n), IV (n) | Intervention | N/A | III (4 / 8), IV (12 / 8) | N/A | 2.03 ± 0.61 | 1.9 ± 0.44 |
Control | N/A | III (7) IV (5) | N/A | 1.67 ± 0.49 | 2.1 ± 0.37 | |
Comparison | Placebo | CABG only | HF drugs only | Placebo | CABG only | |
Follow-up, months | 1, 4, 12 and 18 mo | 3, 6 and 12 mo | 1 and 6 mo | 3, 3, 6 and 12 mo | 1, 3, 6 and 12 mo | |
Assessment modality (yes/no) | ECG | Yes | - | Yes | Yes | Yes |
Echo | Yes | - | Yes | Yes | Yes | |
MRI | No | Yes - CMR | - | Yes - CMR | Yes | |
Cardiac CT | Yes | - | - | - | No | |
SPECT | Yes | - | - | - | Yes | |
Measured outcomes | Safety and adverse event (primary), efficacy, and LV functions LVEF (secondary) | Serious adverse events at 12 mo (primary), the efficacy of hUC-MSCs and collagen scaffold assessed according to the CV-CMR-based LVEF and infarct size at 3, 6 and 12 mo after treatment, and NYHA (secondary) | Changes in LVEDD, LVEF, BNP, 6MWD, symptoms of HF, death, and adverse events | Safety: Adverse events after IV infusion -/-. Efficacy: (primary). Change in LVEF in ECHO, changes in - (LVESV) & (LVEDV) at ECHO; LVEF, LVESV, and LVEDV in CMR; NYHA score (secondary) | LVEF, LV remodeling, myocardial mass, 6MWD, NYHA score change |
- Citation: Safwan M, Bourgleh MS, Aldoush M, Haider KH. Tissue-source effect on mesenchymal stem cells as living biodrugs for heart failure: Systematic review and meta-analysis. World J Cardiol 2024; 16(8): 469-483
- URL: https://www.wjgnet.com/1949-8462/full/v16/i8/469.htm
- DOI: https://dx.doi.org/10.4330/wjc.v16.i8.469