Stone Kevin R, Walgenbach Ann W, Turek Thomas J, Crues John V, Galili Uri
The Stone Clinic, San Francisco, CA, USA.
Stone Research Foundation, San Francisco, CA, 94123, USA.
J Exp Orthop. 2023 Sep 6;10(1):91. doi: 10.1186/s40634-023-00651-7.
ACL reconstruction has a significant failure rate. To address the need for inexpensive strong tissue, a treatment process to "humanize" porcine tissue was developed and tested in primates and humans. This report describes the long-term outcomes from the first human clinical trial using a porcine xenograft ACL reconstruction device.
The study was performed with Z-Lig™ xenograft ACL device in 2003 as a pilot clinical feasibility study. This device was processed to slow its immune-mediated destruction by enzymatic elimination of α-gal epitopes and by partial crosslinking to slow the infiltration of macrophages into the biotransplant.
Ten patients underwent reconstruction with the Z-Lig™ device. Five of 10 patients failed due to subsequent trauma (n = 3), arthrofibrosis (n = 1), and surgical technical error (n = 1). One patient was lost to follow-up after the 12-year evaluation. Each remaining patient reported a stable fully athletic knee. Physical exams are consistent with a score of less than one on the ACL stability tests. MRIs demonstrate mature remodeling of the device. There is no significant degradation in patient-reported outcome scores, physical exams, or MRI appearance from 12 to 20-year follow-ups.
The studies in a small group of patients have demonstrated that implantation of porcine ligament bioprosthesis into patients with torn ACLs can result in the reconstruction of the bioprosthesis into autologous ACL that remains successful over 20 years. The possibility of humanizing porcine tissue opens the door to unlimited clinical material for tissue reconstructions if supported by additional clinical trials.
IV, case series.
前交叉韧带重建术有显著的失败率。为满足对廉价且坚韧组织的需求，研发了一种将猪组织“人源化”的治疗方法，并在灵长类动物和人类身上进行了测试。本报告描述了使用猪异种移植前交叉韧带重建装置的首例人体临床试验的长期结果。
2003年使用Z-Lig™异种移植前交叉韧带装置进行了该研究，作为一项试点临床可行性研究。该装置经过处理，通过酶法消除α-半乳糖表位以及部分交联来减缓免疫介导的破坏，以减缓巨噬细胞向生物移植物中的浸润。
10例患者接受了Z-Lig™装置重建术。10例患者中有5例因后续创伤（n = 3）、关节纤维化（n = 1）和手术技术失误（n = 1）而失败。1例患者在12年评估后失访。其余每位患者均报告膝关节稳定，可完全进行运动。体格检查结果与前交叉韧带稳定性测试得分低于1分一致。磁共振成像显示装置已成熟重塑。在12年至20年的随访中，患者报告的结局评分、体格检查或磁共振成像表现均无显著恶化。
对一小部分患者的研究表明，将猪韧带生物假体植入前交叉韧带撕裂患者体内可使生物假体重建为自体前交叉韧带，且在20多年来一直保持成功。如果有更多临床试验支持，猪组织人源化的可能性为组织重建带来了无限的临床材料。
IV，病例系列。
