Regentis生物材料报告说,由于GelrinC治疗,膝盖软骨几乎完全修复,表明美国有长期的疼痛缓解和功能性改善。 第三阶段试验。
Regentis Biomaterials reports near-complete knee cartilage repair with its GelrinC treatment, showing lasting pain relief and functional improvement in a U.S. Phase III trial.
Regentis生物材料报告,其GelrinC软体修复治疗取得了长期成功,表明在手术两年后几乎完全恢复了膝盖软体,平均MOCART得分为88.8,表明组织几乎与健康的软体几乎无法区分。
Regentis Biomaterials reports long-term success of its GelrinC cartilage repair treatment, showing near-complete knee cartilage restoration two years post-procedure, with an average MOCART score of 88.8—indicating tissue nearly indistinguishable from healthy cartilage.
这是美国食品和药物管理局批准的首次在临床试验中使用MOCART这一数量性MRI标准作为临床试验的主要终点。
This is the first time MOCART, a quantitative MRI standard, was used as a primary endpoint in a clinical trial, approved by the U.S. FDA.
在欧洲已有的无细胞、现成的体液凝胶植入器 在美国处于关键位置
The cell-free, off-the-shelf hydrogel implant, already available in Europe, is in a pivotal U.S.
第三阶段试行,入学率超过50%。
Phase III trial with over 50% enrollment.
结果显示,在四年多的时间里,疼痛持续缓解,功能不断改善,组织不断组织成熟。
Results show sustained pain relief and functional improvement for more than four years, with ongoing tissue maturation.