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Table 4 Storage lesion of the IND (ancillary studies on the IND, to determine maximum shelf life)

From: Safety and feasibility of cell-based therapy of autologous bone marrow-derived mononuclear cells in plate-stabilized proximal humeral fractures in humans

Parameter

24 h

48 h

72 h

p values (24 vs 28 h)

p values (24 vs 72 h)

Cell number [absolute values]

1.7E7 (1.9E7/7.7E6)

1.6E7 (1.7E7/1.1E7)

1.1E7 (1.6E7/1.0E7)

p = 0.74, not significant

p = 0.31, not significant

Cell number [% 24 h]

100 (100/100)

95 (100/77.9)

74.1 (87/64.7)

p = 0.17, not significant

p = 0.005, significant

Vital cells [% BMC]

98.8 (98.8/98.4)

96.9 (96.9/96.9)

92.21 (94.0/84.1)

p = 0.11, not significant

p = 0.043, significant

Vital cells [% 24 h]

100 (100/100)

98.0 (98.9/97.1)

94.4 (97.3/85.2)

p = 0.06, trend

p = 0.003, significant

CD34+ CD45+ [% BMC]

1.33 (1.95/1.13)

1.47 (1.85/1.24)

1.32 (1.36/1.15)

p = 1.0, not significant

p = 0.81, not significant

CD34+ CD45+ CD133+ [% BMC]

0.66 (0.75/0.04)

0.6 (0.95/0.43)

0.55 (0.65/0.5)

p = 1.0, not significant

p = 1.0, not significant

CD45− CD271+ [% BMC]

0.01 (0.03/0.01)

0.03 (0.03/0.03)

0.02 (0.03/0.01)

1.0, not significant

1.0, not significant

CFU-F [1.0E6 BMC]

21.0 (1.95/1.13)

3.0 (9.5/2.5)

1.0 (3.0/0.5)

p = 0.1, trend

p = 0.04, significant

CFU-F [% of 24 h]

100.0 (100/100)

22.0 (9.7/76.2)

3.2 (0/23.8)

p = 0.04, significant

p = 0.03, significant