Table 4b.

Linear Regression: Associations Between Manufacturing Factors and “Postpurified” Quality Parameters in High-Purity Fraction of Islet Product

Manufacturing Factors		Islet Score*	Size†	Fragment†	Density†	Border†	Shape†
		Coef.‡	Coef.‡	Coef.‡	Coef.‡	Coef.‡	Coef.‡
Cold ischemic time (h)	(≤10 vs. >10)			0.1§	0.1§¶	0.1§
Enzyme brand	(liberase MTF vs. Serve-NB1 or Sigma V)	1.1¶#	0.4¶**	0.3¶**	0.1§	0.2§¶	0.2#
Collagenase††	(U/g of digested pancreas)						0.01¶#
Trimming time (min)	(≥20 vs. <20)	0.9#
Cannulation time (min)	(<30 vs. ≥30)	1.0¶#	0.3§¶			0.2§	0.2§
Perfusion method	(mechanical vs. manual)	1.0#	0.3#	0.2§		0.2§¶	0.2#
No. of cut pancreatic pieces	(≥15 vs. <15)		-0.2§
Digestion time (min)	(≥10 vs. <10)			-0.2§
Dilution time (min)	(≥30 vs. <30)		0.3§

Each cell description: regression coefficient in either multivariate (marked by ¶) or univariate linear regressions.

^*Islet score equal to sum of islet morphology subscores.

^†Islet morphology subscores include morphologic evaluation on size, fragment, density, border, and shape; each subscore ranges from 0 to 2, and total islet score ranges from 0 to 10.

^‡Coefficient from regression models.

^††Collagenase defined as concentration of used collagenase per gram of digested pancreas tissue.

^¶Statistics calculated from multivariate regressions.

^§ p

^#p < 0.01;

^**p < 0.001.