Hunt Neil, Oliver Gabriel, Borrego Alberto Francés, Pietrzak William S
Fortius Clinic London UK.
Hospital Universitari de Bellvitge Barcelona Spain.
J Exp Orthop. 2025 Sep 23;12(3):e70433. doi: 10.1002/jeo2.70433. eCollection 2025 Jul.
Many graft choices exist for anterior cruciate ligament (ACL) reconstruction including autograft, allograft and, to a lesser extent, synthetic graft, with all having significant limitations. While xenograft can circumvent many of these limitations, potential immunogenic response remains a concern. A novel decellularization process has been developed to remove the principal immunogenic epitopes from porcine digital extensor tendon to produce a nonimmunogenic, biomechanically appropriate ACL xenograft for clinical use. This study reports the first in-human series utilising this xenograft.
This was a 5-year study of 40 patients, mean age 31.9 years (range: 18-48), 70% male, with mean follow-up of 41.9 months (6-60 months) and 19 reaching 5 years. Radiographic and MRI analysis was performed as were a variety of clinical assessments, including arthrometric measurement of anterior tibial translation, Lachman test, Pivot Shift test, International Knee Documentation Committee (IKDC) Subjective questionnaire, and Knee Injury and Osteoarthritis Outcome Score (KOOS) questionnaire. All adverse events were recorded. Clinical outcomes were compared to those reported in the literature for autograft and/or allograft.
Adverse events included six graft ruptures which were limited to young males. No evidence of an immunogenic response was noted. Clinical outcome assessments and imaging analysis were in line with those reported in the literature for autograft and/or allograft.
This first in-human study of a novel porcine ACL xenograft demonstrated that it is biomechanically and immunologically suitable for clinical use with no safety concerns evident.
Level IV.
前交叉韧带（ACL）重建有多种移植物可供选择，包括自体移植物、同种异体移植物，以及较少使用的合成移植物，但这些都有明显的局限性。虽然异种移植物可以规避其中许多局限性，但潜在的免疫原性反应仍是一个问题。已开发出一种新型脱细胞方法，从猪指伸肌腱中去除主要免疫原性表位，以生产出一种无免疫原性、生物力学性能合适的ACL异种移植物用于临床。本研究报告了首例使用这种异种移植物的人体系列研究。
这是一项为期5年的研究，纳入40例患者，平均年龄31.9岁（范围：18 - 48岁），70%为男性，平均随访41.9个月（6 - 60个月），19例随访达5年。进行了影像学和MRI分析以及各种临床评估，包括胫骨前移的关节测量、拉赫曼试验、轴移试验、国际膝关节文献委员会（IKDC）主观问卷以及膝关节损伤和骨关节炎疗效评分（KOOS）问卷。记录所有不良事件。将临床结果与文献中报道的自体移植物和/或同种异体移植物的结果进行比较。
不良事件包括6例移植物破裂，均限于年轻男性。未发现免疫原性反应的证据。临床结果评估和影像学分析与文献中报道的自体移植物和/或同种异体移植物的结果一致。
这项首例关于新型猪ACL异种移植物的人体研究表明，它在生物力学和免疫学上适合临床使用，且无明显安全问题。
IV级。
