Clinical experience with cryopreserved mesenchymal stem cells for cardiovascular applications: A systematic review

Table 2 Baseline characteristics of randomized clinical trials with cryopreserved human bone marrow mesenchymal stem cells for heart disease, n (%)

Ref.		Chullikana et al[16], 2015, India	Hare et al[17], 2009, United States	Bolli et al[15], 2020, United States	Perin et al[18], 2015, United States
Study type		RCT	RCT	RCT	RCT
Phase		I/II	I	I	II
Condition		MI	MI	HF	HF
Sample size	Total	20	53	31	60
	Intervention (% male)	10 (100)	34 (82.4)	14 (43)	45 (97.8)
	Control (% male)	10 (80)	19 (78.9)	17 (24)	15 (73.3)
Age (mean ± SD)	Intervention	47.31 ± 12.10	59 ± 12.3	54.7 ± 12.8	62.2 ± 10.3
	Control	47.79 ± 6.48	55 ± 10.2	58.2 ± 11.2	62.7 ± 11.2
BMI (mean ± SD)	Intervention	23.32 ± 3.74	29.8 ± 6.7	30.2 ± 9.0	29.8 ± 4.1
	Control	24.86 ± 1.88	30.3 ± 4.3	30.4 ± 6.5	31.3 ± 9.2
Number of smokers	Intervention	N/A	3 (8.8)	5 (36)	7 (15.6)
	Control	N/A	2 (10.5)	3 (18)	2 (13.3)
HTN	Intervention	N/A	16 (17.6)	6 (43)	29 (64.4)
	Control	N/A	9 (47.4)	10 (59)	9 (60)
DM	Intervention	N/A	6 (17.6)	3 (21)	13 (28.9)
	Control	N/A	1 (5.3)	5 (29)	2 (13.3)
NYHA; I (n), II (n), III (n), IV (n)	Intervention	N/A	N/A	II (13), III (1)	II (31), III (14)
	Control	N/A	N/A	II (13), III (4)	II (6), III (9)
Comparison		Placebo (multiple electrolytes injection)	Placebo	Placebo	Placebo
Follow-up, months		Six months till two years	Six months	6 and 12 months	3, 6, 12 months
Assessment modality (yes/no)	ECG	No	Yes	Yes	No
	Echo	Yes	Yes	No	Yes
	MRI	Yes	Yes	Yes (CMR)	No
	Cardiac CT	No	Yes	No	No
	SPECT	Yes	No	No	Yes
Measured outcomes		Adverse events, LVEF (Echo & SPECT), total perfusion score, and total volume of infarct	Safety, adverse events, LVEF (Echo), and 6MWD	Safety and feasibility of allogenic MSC administration in this population (primary). Effects of allogenic MSC administration on LV function (LVEF, LVEDV, LVESV, scar morphology) and functional status (6MWD, MLHFQ) (secondary)	Safety (primary), LV volume, LVEF, 6MWD (secondary)

RCT: Randomized controlled trial; MI: Myocardial infarction; HF: Heart failure; BMI: Body mass index; N/A: Not applicable; HTN: Hypertension; DM: Diabetes mellitus; NYHA: New York Heart Association; ECG: Electrocardiogram; MRI: Magnetic resonance imaging; CT: Computed tomography; SPECT: Single-photon emission computed tomography; CMR: Cardiac magnetic resonance; MSCs: Mesenchymal stem cells; LV: Left ventricle; LVEF: Left ventricular ejection fraction; LVESV: Left Ventricular end-systolic volume; LVEDV: Left ventricular end-diastolic volume; 6MWD: Six-minute walk distance; MLHFQ: Minnesota Living with Heart Failure Questionnaire.