Safety and efficacy of treating symptomatic, partial-thickness rotator cuff tears with fresh, uncultured, unmodified, autologous adipose-derived regenerative cells (UA-ADRCs) isolated at the point of care: a prospective, randomized, controlled first-in-human pilot study

Table 4 Characteristics of UA-ADRCs applied in this pilot study (modified intention-to-treat population)

Variable	Values	Final product acceptance criterion according to protocol
Cell number, × 10⁶; median; mean (SD; min; max)	10.4; 11.4 (3.1; 8.6; 20)	≥ 5×10⁶
Cell yield^a, × 10⁵/g; median; mean (SD; min; max)	2.1; 2.3 (0.6; 1.7; 4.0)	≥ 1.0×10⁵/g
Cell viability, %; median; mean (SD; min; max)	92.3; 88.5 (8.7; 75; 97.3)	> 70%
Endotoxin, Equivalent Unit (EU) total^b, median; mean (SD; min; max)	1.0; 1.0 (0.8; 0; 2.23)^c	< 2.5 EU total
Gram stain, negative (%)	11 (100)	Negative

^aNumber of cells isolated per gram of tissue processed by the Transpose RT/Matrase system (InGeneron)
^bIn the final cell suspension
^cThese values were calculated without the data of one subject whose final cell suspension contained 60.5 EU total. In this case, the amount of endotoxin was miscalculated at release. This was discovered after the subject had already completed the follow-up examinations. The incident was reported to FDA who accepted the Corrective and Preventive Action and the report

ISSN: 1749-799X