Table 3.
Overview of clinical data of patients treated with autologous chondrocyte implantation using spheroids.
| Lead Author (Year) | Patients (n) | Lesion Size (cm2) | Follow-Up (Months) | KOOS | MOCART | IKDC Subjective Score | Lysholm | Other | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall | Pain | Sympt | ADL | Sports | QOL | ||||||||
| Phase II; Niemeyer (2016) [10] | 75 | 5.0 ± 1.9 | 12 | 73.2 ± 17.6 | d 16.4 ± 20.2 § | d 12.9 ± 17.3 § | d 12.4 ± 17.9 § | d 17.1 ± 28.9 § | d 22.6 ± 24.4 § | 72.4 ± 13.0 | 68.0 ± 18.3 § | Safety | |
| Phase II; Becher (2017) [11] | 75 | 5.0 ± 1.9 | 36 | d 19.9 ± 16.3 § | d 18.2 ± 18.2 § | d 14.8 ± 17.5 § | d 13.6 ± 16.6 § | d 24.3 ± 26.6 § | d 28.9 ± 23.8 § | 75.2 ± 13.4 § | 73.2 ± 18.8 § | Safety | |
| Phase II; Niemeyer (2020) [12] | 75 | 5.0 ± 1.9 | 48 | d 20.1 ± 17.3 | d 18.8 ± 18.2 | d 14.0 ± 17.5 | d 14.2 ± 17.9 | d 23.2 ± 28.9 | d 30.1 ± 24.1 | 75.5 ± 13.1 | 74.6 ± 18.7 | IKDC knee examination, safety | |
| Phase III; Niemeyer (2019) [13] | 52 | 2.2 ± 0.7 | 12 | 78.7 ± 18.6 | 89.9 ± 16.5 $ | 71.6 ± 27.5 $ | 79 ± 14 | Macroscopic repair, histology, safety | |||||
| 24 | 81.5 ± 17.3 | 92.1 ± 13.0 $ | 74.4 ± 24.9 $ | 76 ± 16 | d 24.2 ± 16.9 | d 4.9 ± 4.3 m | |||||||
| Phase III; Hoburg (2020) [14] | 52 | 2.2 ± 0.7 | 36 | 83.2 ± 14.9 | 92.8 ± 12.0 | 79.2 ± 23.2 | Safety | ||||||
| Niemeyer (2020) [21] | Patella 45 * | 5.4 ± 1.6 | 60 | 82.6 ± 14.0 | 88.3 ± 14.4 | 87.6 ± 13.9 | 91.4 ± 10.0 | 76.0 ± 23.0 | 70.6 ± 21.5 | ||||
| Femur 28 * | 6.0 ± 1.7 | 81.9 ± 18.6 | |||||||||||
| Siebold (2014) [16] | 10 | 7.2 ± 3.5 | 24 | 74.4 ± 16.9 | 13.7 ± 1.8 m | 63.9 ± 22.1 | 74.1 ± 18.7 | Kujala | |||||
| Hoburg (2019) [19] | Adolescent 29 | 4.6 ± 2.4 | 63.3 | 82.6 ± 11.6 | 88.5 ± 10.4 | 83.1 ± 16.1 | 94.9 ± 7.4 | 78.6 ± 20.2 | 67.6 ± 17.2 | 74.7 ± 12.0 | 81.1 ± 17.7 | 21.0 ± 2.4 m | |
| Adult 42 * | 4.7 ± 1.2 | 48.4 | 84.6 ± 11.7 | 90.9 ± 8.9 | 91.5 ± 7.0 | 94.2 ± 7.9 | 77.7 ± 21.2 | 69.0 ± 22.3 | 77.2 ± 11.2 | 80.5 ± 15.2 | 22.3 ± 1.9 m | ||
| Fickert (2012) [15] | 37 | 4.4 (1.0–12.0) | 12 | 70 | 64 | 82.5 (34–100) | Tegner, VAS pain, SF-36, safety | ||||||
| Siebold (2016) [17] | 41 | 4.3 ± 3.4 | 34 ± 19.2 | 81 ± 12.9 | 76.8 ± 16.6 | 85.1 ± 14.9 | 55.3 ± 27.7 | 50.6 ± 23.8 | 63.0 ± 18.8 | 79.0 ± 18.0 | Tegner, macroscopic repair | ||
| Siebold (2018) [18] | 30 | 6 ± 3.1 | 34.8 ± 10.2 | 82.2 ± 16.1 | 81.7 ± 12.1 | 86.3 ± 15.6 | 71.0 ± 16.0 | 72.3 ± 16.9 | 60 ± 21 m | 84.2 ± 5.6 | 77.7 ± 14.6 | Tegner, EQ-VAS | |
| Sumida (2021) [22] | 30 | 4.4 ± 3.7 | 14.9 ± 16.3 | Macroscopic repair | |||||||||
| Grevenstein (2020) [20] | 5 | 5.5–16 | Histology | ||||||||||
Mean ± SD or (range) values are provided. d: Delta; meaning change in the outcome score compared to baseline. * Subgroup analyses from the phase II clinical trial. m modified version of the score was used. sKOOS: Knee injury and osteoarthritis outcome score. Sympt: Symptoms. ADL: Activities of daily living. Sports: Sports and recreation. QOL: Quality of life. MOCART: Magnetic resonance observation of cartilage repair tissue. IKDC: International knee documentation committee. SF: Short form. EQ-VAS: EuroQol Visual Analogue Scale. §: These results were provided in Niemeyer et al., 2020 [12]. $: These results were provided in Hoburg et al., 2020 [14].