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Table 2 Exposure to the test product: dose administered

From: Safety of three different product doses in autologous chondrocyte implantation: results of a prospective, randomised, controlled trial

Dose group: Low Medium High All
N = 24 N = 25 N = 24 N = 73
Spheroids/cm2 based on defect area as found by arthroscopya
 Mean ± SD 10.8 ± 15.7 27.8 ± 13.0 40.5 ± 11.0 26.44 ± 17.9
 Median 7.0 28.8 41.80 28.2
 Range 6.8–84.0 11.3–83.1 11.6–59.8 6.8–84.0
Spheroids/cm2 based on defect area as found at implantationa
 Mean ± SD 7.6 ± 3.1 23.3 ± 6.7 37.7 ± 12.4 22.8 ± 14.8
 Median 7.0 24.7 40.7 23.4
 Range 4.7–21.0 9.3–30.7 11.6–59.8 4.7–59.8
Number of spheroids
 Mean ± SD 37.5 ± 10.8 128.1 ± 41.3 204.3 ± 51.4 123.3 ± 78.1
 Median 35 120 209 120
 Range 28–63 51–224 93–290 28–290
  1. aArea at arthroscopy was used for determination of dose (amount of chondrosphere®); area at implantation was post-debridement and therefore more accurate (see text)