Tissue-source effect on mesenchymal stem cells as living biodrugs for heart failure: Systematic review and meta-analysis

Table 3 Baseline characteristics of randomized clinical trials included in the meta-analysis of bone-marrow-derived mesenchymal-stem-cell-based cardiac therapy, n (%)

		Ulus et al[25], 2020 (Türkiye)	Rodrigo et al[32], 2013 (Netherlands)	Kim et al[16], 2018 (South Korea)	Bolli et al[23], 2020 (USA)
Study type		Open-label RCT	RCT	RCT	RCT
Phase		I/II	I/II	I	I
Condition		CIC	MI	MI	HF
Sample size	Total	28	54	26	31
	Intervention (male)	12 (100)	9 (78)	14 (100)	14 (43)
	Control (male)	16 (100)	45 (78)	12 (100)	17 (24)
Mean age (mean ± SD)	Intervention	56.9 ± 5.20	56 ± 8	55.3 ± 8.6	54.7 ± 12.8
	Control	65.3 ± 6.8	61 ± 11	57.8 ± 8.9	58.2 ± 11.2
Mean BMI (mean ± SD)	Intervention	26.2 ± 3.12	N/A	N/A	30.2 ± 9.0
	Control	26.6 ± 4.8	N/A	N/A	30.4 ± 6.5
Number of smokers	Intervention	11 (91.6)	6 (67)	5 (35.7)	5 (36)
	Control	15 (88.2)	19 (42)	5 (41.7)	3 (18)
HTN	Intervention	6 (50)	4 (44)	5 (35.7)	6 (43)
	Control	11 (64.7)	18 (40)	5 (41.7)	10 (59)
DM	Intervention	4 (33.3)	1 (11)	3 (21.4)	3 (21)
	Control	9 (52.9)	5 (11)	2 (16.7)	5 (29)
NYHA; I (n), II (n), III (n), IV (n)	Intervention	2.2 ± 0.6	N/A	N/A	II (13), III (1)
	Control	2.1 ± 0.37	N/A	N/A	II (13), III (4)
Comparison		CABG only	No placebo (optimal MI treatment)	No placebo (optimal MI treatment)	HF treatments
Follow-up duration		1, 3, 6, and 12 mo	3, 6, 12 mo, 4, 5 years	4 and 12 mo	6 and 12 mo
Assessment modality (Yes/no)	ECG	Yes	Yes - Holter	No	Yes
	Echo	Yes	Yes	Yes	No
	MRI	Yes	No	No	Yes - CMR
	Cardiac CT	No	No	No	No
	SPECT	Yes	Yes	Yes	No
Measured outcomes		LVEF, LV remodeling, myocardial mass, 6MWD, NYHA score	Safety and feasibility of IM delivery after PCI for MI (primary). Efficacy regarding change in infarct size, LVEF, LVEDV, and LVESV (secondary)	Absolute changes in global LVEF from baseline to 4 months after PCI using SPECT, Echo changes in global LVEF at 12 mo (primary). Changes in LVEDV, LVESV, and MACE (secondary)	Safety and feasibility of allogenic MSC in population (primary). Effects of allogenic MSC on LV function (LVEF, LVEDV, LVESV, scar), morphology, and functional status (6MWD, MLHFQ) (secondary)

MSCs: Mesenchymal stem cells; HT: Hypertension; DM: Diabetes mellitus; BMI: Body mass index; MAE: Major adverse events; MACE: Major adverse cardiac events; CABG: Coronary artery bypass grafting; HF: Heart failure; LV: Left ventricle; LVEF: Left ventricular ejection fraction; LVEDV: Left ventricular end diastolic volume; LVESV: Left ventricular end systolic volume; MI: Myocardial infarction; 6MWD: 6-min walking distance test; N/A: Not available; NYHA: New York Heart Association; PCI: Percutaneous coronary intervention; RCT: Randomized controlled trial; ECG: Electrocardiogram; Echo: Echocardiogram; MRI: Magnetic resonance ımaging; CT: Computed tomography; SPECT: Single-photon emission computed tomography; MLHFQ: Minnesota living wıth heart faılure questionnaire.