Lenz Julia Elisabeth, Weber Johannes, Zellner Johannes, Zimmermann Gerald, Müller Peter E, Barié Alexander, Popp Dominik, Ostermeier Sven, Krackhardt Tilmann, Mehl Julian, Alt Volker, Angele Peter
Department of Trauma Surgery University Medical Center Regensburg Regensburg Germany.
Sporthopaedicum Regensburg Straubing Germany.
J Exp Orthop. 2025 Aug 13;12(3):e70346. doi: 10.1002/jeo2.70346. eCollection 2025 Jul.
The focus of this study was to evaluate the safety and efficacy of NOVOCART® 3D-treatment over a period of 36 months post-transplantation.
This study was designed as a prospective, multicenter, single-arm, non-interventional investigation, aimed at evaluating the safety and efficacy of NOVOCART® 3D in patients with localized cartilage defects in the knee joint. 80 patients were enroled across 8 study centres and were followed post-operatively for a duration of 36 months. Safety assessments were conducted throughout the study period, while effectiveness data were evaluated pre-operatively and at 3, 12, 18, 24, and 36 months following cell transplantation, utilizing the International Knee Documentation Committee 2000 score (IKDC 2000).
Over the 3-year observation period among the 80 study patients, the incidence of surgery or product-related adverse events stood at 12.5%. Subjective scores according to IKDC 2000 demonstrated improvement, with a mean change from baseline of 30.5 ± 21.5 score points at 36 months. Similarly, the mean IKDC function score exhibited continuous enhancement, with a mean difference of 3.2 ± 3.0 score points. These changes from baseline were associated with nominally significant -values from the 12-month mark onwards. The subgroup analysis revealed that only higher baseline scores and concurrent surgeries negatively impacted outcome parameters. Female sex, retro-patellar lesions, uncontained lesions, lesions with intralesional osteophytes or osteochondral defects did not exhibit any significant influence.
The NISANIK study indicates the safety of NOVOCART® 3D treatment. Regarding effectiveness, patients in the study demonstrated a notable and progressively increasing mean improvement compared to their pre-operative condition. The study furthermore demonstrated that NOVOCART® is universally applicable across all age groups and Body Mass Index ranges, and it can also be effectively used in patients with female sex, larger lesions, retro-patellar lesions and in such having received bone-grafting without compromising the outcome, unlike related procedures.
Level II, therapeutic, prospective cohort study.
本研究的重点是评估NOVOCART® 3D治疗在移植后36个月内的安全性和有效性。
本研究设计为一项前瞻性、多中心、单臂、非干预性调查，旨在评估NOVOCART® 3D对膝关节局限性软骨缺损患者的安全性和有效性。80名患者在8个研究中心入组，并在术后随访36个月。在整个研究期间进行安全性评估，同时在细胞移植术前以及术后3、12、18、24和36个月利用国际膝关节文献委员会2000评分（IKDC 2000）评估有效性数据。
在80名研究患者的3年观察期内，手术或产品相关不良事件的发生率为12.5%。根据IKDC 2000的主观评分显示有所改善，在36个月时与基线相比平均变化为30.5±21.5分。同样，平均IKDC功能评分持续提高，平均差异为3.2±3.0分。从基线开始的这些变化从12个月起具有名义上的显著p值。亚组分析显示，只有较高的基线评分和同期手术对结果参数有负面影响。女性、髌后病变、未包含的病变、伴有病灶内骨赘或骨软骨缺损的病变未显示出任何显著影响。
NISANIK研究表明了NOVOCART® 3D治疗的安全性。在有效性方面，与术前状况相比，研究中的患者平均改善显著且逐渐增加。该研究还表明，NOVOCART®普遍适用于所有年龄组和体重指数范围，并且它也可有效地用于女性、较大病变、髌后病变以及接受过骨移植的患者，而不会像相关手术那样影响结果。
二级，治疗性前瞻性队列研究。
