Table 2.
Clinical trials of CTE products employing type I collagen scaffolds
| Product name | Markers | Main results | References |
|---|---|---|---|
| NOVOCART®3D | Type I collagen sponges with bilayer structure | (n = 28) Significant improvement of clinical results after 24 months follow up compared to baseline, based on subjective scoring system: IKDCa (36.0 ± 15.0 ) and Noyes sport ratinga (38.9 ± 31.0) MOCARTb showed low score up to 6 months (60.3 ± 17.4), but it exhibited development of cartilage repair after 24 months (73.2 ± 12.4) | [42] |
| MACI® | Membrane of type I/III collagen‡ | (n = 144) MACI® showed more effective cartilage healing than microfracture (MF) based on KOOSa scoring system of pain (MACI®: 82.5 ± 16.2 vs MF 70.9 ± 24.2) and function (MACI®: 60.9 ± 27.8 vs MF: 48.7 ± 30.3) | [43] |
| CaReS® | Type I collagen gel‡ | (n = 17) All three scoring systems of clinical outcome showed significant improvement of CaReS® treated patient from baseline IKDCa (31.7 ± 12.7 to 61.3 ± 18.2), Lysholma (43.6 ± 11.4 to 64.7 ± 17.1), Cincinnatia (31.5 ± 13.1 to 56.2 ± 13.9)). No significant differences (IKDCa) were observed between CaReS® (61.3 ± 18.2) and MF groups (50.1 ± 24.9) | [44] |
| NeoCart® | Type I collagen gel loaded into sponges of same material‡ | (n = 49) Pain scoring system of KOOSa showed the significant improvement for NeoCart®-treated group compared to baseline at six, twelve, and twenty-four months. The improvement from baseline is greater for NeoCart®-treated group than MF-treated group | [45] |
| Transferred to Japan Tissue Engineering Co., Ltd. with brand name JACC® | Type I atelocollagen gel | (n = 28) Lysholm scoresa showed significant improvement from the baseline over 25 months. Arthroscopic evaluation revealed 26 of 28 knees (93%) were graded as good or excellent. Biomechanical test revealed that transplants had similar stiffness with nearby cartilage | [46] |
‡Controlled with MF
aClinical evaluation: KOOS, Knee injury and Osteoarthritis Outcome Score; IKDC, International Knee Documentation Committee; Lysholm; Cincinnati; Noyes sport rating
bCartilage evaluation: MOCART®, Modified magnetic resonance observation of cartilage repair tissue