Establishing delivery route-dependent safety and efficacy of living biodrug mesenchymal stem cells in heart failure patients

Table 2 Outcome and follow-up characteristics of included trials

Ref.	Trial registry	Arm	FU		Imaging				SAE/death	LVEF (%)		6MWD (meter)		Pro-BNP (pg/mL)
			For 1° outcome	For LVEF	Echo	CCT	CMR	SPECT		Baseline	FU	Baseline	FU	Baseline	FU
Ascheim et al[21], 2014	NCT01442129	Exp	12	12	Yes	No	No	No	19/0	17.50 ± 3.90	24.00 ± 3.90	NA	883.00 ± 233.00	NA	NA
		Ctrl							9/3	19.30 ± 5.10	22.50 ± 5.10	NA	1080.00 ± 359.50	NA	NA
Perin et al[27], 2015	NCT00721045	Exp	36	12	Yes	No	No	Yes	10/2	31.30 ± 8.58	32.40 ± 8.70	401.60 ± 96.40	427.30 ± 115.10	436.80 ± 563.40	347.30 ± 335.69
		Ctrl							5/3	34.60 ± 6.43	33.10 ± 9.30	319.30 ± 121.40	346.60 ± 121.80	217.70 ± 149.60	319.80 ± 193.02
Mathiasen et al[25], 2015	NCT00644410	Exp	6	6	Yes	Yes	Yes	No	13/1	28.20 ± 9.30	33.20 ± 3.80	401.00 ± 70.00	421.40 ± 76.60	582.69 ± 970.01	NA
		Ctrl							16/1	25.10 ± 8.50	23.80 ± 3.70	385.00 ± 81.00	414.72 ± 79.60	564.08 ± 981.86	NA
Zhao et al[19], 2015	NA	Exp	6	6	No	No	No	No	1/2	30.00 ± 4.50	49.00 ± 5.10	312.17 ± 89.19	466.36 ± 82.90	4376.27 ± 510.71	1648.96 ± 304.54
		Ctrl							0/7	28.00 ± 4.90	39.00 ± 3.50	295.07 ± 46.87	334.27 ± 43.80	4701.76 ± 513.53	2835.09 ± 412.03
Patel et al[23], 2016	NCT01670981	Exp	12	12	Yes	No	No	No	31/2	26.50 ± 5.10	28.10 ± 6.13	313.00 ± 100.00	370.62 ± 114.30	1755.00 ± 1842.00	NA
		Ctrl							41/7	24.40 ± 6.00	25.30 ± 6.10	302.00 ± 105.00	353.43 ± 128.30	2132.00 ± 2021.00	NA
Butler et al[22], 2017	NCT02467387	Exp	6	3	No	No	Yes	No	0/0	34.30 ± 7.91	34.10 ± 9.70	NA	NA	806.27 ± 1387.85	768.25 ± 2945.53
		Ctrl							0/0	34.50 ± 7.49	36.70 ± 5.40	NA	NA	NA	NA
Xiao et al[29], 2017	NA	Exp	12	12	Yes	No	No	Yes	5/0	34.10 ± 3.600	41.00 ± 6.70	309.00 ± 84.70	NA	539.20 ± 213.60	NA
		Ctrl							7/2	33.70 ± 4.00	34.30 ± 5.30	323.30 ± 89.40	NA	575.30 ± 207.60	NA
Florea et al[18], 2017	NCT02013674	Exp	12	12	Yes	Yes	No	No	2/1	30.10 ± 8.80	33.10 ± 7.30	434.90 ± 120.00	463.00 ± 143.10	377.70 ± NA	NA
		Ctrl							3/0	37.60 ± 13.30	37.30 ± 13.00	398.70 ± 111.60	409.70 ± 130.20	532.30 ± NA	NA
Yau et al[20], 2019	NCT02362646	Exp	12	6	Yes	No	No	No	88/15	17.30 ± 5.80	19.00 ± 9.40	NA	NA	NA	NA
		Ctrl							41/8	16.20 ± 6.00	17.60 ± 6.20	NA	NA	NA	NA
Bolli et al[26], 2021	NCT02501811	Exp	12	12	No	No	Yes	No	19/5	29.23 ± 6.30	30.50 ± 6.90	367.72 ± 83.85	398.72 ± 93.10	1026.07 ± 2702.11	640.37 ± 1512.69
		Ctrl							13/4	29.66 ± 6.18	29.40 ± 5.90	367.60 ± 85.60	384.88 ± 101.70	856.72 ± 1364.72	1072.32 ± 2161.64
Qayyum et al[28], 2023	NCT03092284	Exp	12	6	Yes	No	No	No	21/3	34.20 ± 7.90	34.80 ± 5.80	388.00 ± 92.00	400.00 ± 86.10	1382.71 ± 1538.32	1850.22 ± 951.24
		Ctrl							11/0	33.76 ± 2.70	33.80 ± 6.90	416.00 ± 121.00	447.87 ± 120.20	1283.77 ± 1206.81	1589.83 ± 543.70
Qayyum et al[28], 2023	NCT02673164	Exp	12	6	Yes	No	No	No	26/3	31.60 ± 7.20	32.80 ± 7.50	419.00 ± 12.00	432.00 ± 13.00	1495.00 ± 2242.00	1607.00 ± 274.00
		Ctrl							10/2	32.00 ± 8.90	34.70 ± 9.70	423.00 ± 18.00	451.00 ± 19	1828.00 ± 2376.00	1652.00 ± 595.00

6MWD: 6-minute walk distance; CCT: Cardiac computed tomography; CMR: Cardiac magnetic resonance imaging; Ctrl: Control arm; Echo: Echocardiography; Exp: Exposure arm; FU: Follow-up; LVEF: Left ventricular ejection fraction; Pro-BNP: Pro-B-type natriuretic peptide; SAE: Serious adverse events; SPECT: Single-photon emission computed tomography.