Center for Orthopaedic Innovation, Mercy Medical Center, Baltimore, MD, USA.
Institute for Foot and Ankle Reconstruction, Mercy Medical Center, Baltimore, MD, USA.
Cartilage. 2022 Apr-Jun;13(2):19476035221093065. doi: 10.1177/19476035221093065.
Biologics are increasingly used for cartilage repair and osteoarthritis (OA) treatment. This study aimed to provide an overview of the clinical trials conducted on this subject.
Two-word combinations of two sets of key words "cartilage"; "joint"; "osteoarthritis" and "biologics"; "stem cells"; "cell implantation" were used to search the database of ClinicalTrials.gov and supplemented with searches of PubMed and EMbase. The registered trials were analyzed for clinical conditions, completion status, phases, and investigated biologics. Recently completed trials with posted/published results were summarized.
From 2000 to 2022, a total of 365 clinical trials were registered at ClinicalTrials.gov to use biologics for cartilage repair and OA treatment. Since 2006, the number of registered trials accelerated at an annual rate of 16.4%. Of the 265 trials designated with a phase, 72% were early Phase 1, Phase 1, and Phase 2. Chondrocytes and platelet-rich plasma (PRP) were studied in nearly equal number of early- and late-stage trials. Mesenchymal stem/stromal cells (MSCs) were the most commonly investigated biologics (38%) and mostly derived from bone marrow and adipose tissue (70%). In last 5 years, 32 of the 72 completed trials posted/published results, among which seven Phase 3 trials investigated chondrocytes, PRP, bone marrow aspirate concentrate, hyaluronic acid, collagen membrane, and albumin.
There was a rapid increase in the number of registered clinical trials in recent years, using a variety of biologics for cartilage repair and OA treatment. Majority of the biologics still require late-stage trials to validate their clinical effectiveness.
生物制剂越来越多地用于软骨修复和骨关节炎（OA）治疗。本研究旨在对该领域的临床试验进行概述。
使用两组关键词“软骨”和“关节”和“骨关节炎”和“生物制剂”和“干细胞”和“细胞植入”的两个词组合，在 ClinicalTrials.gov 数据库中进行搜索，并辅以 PubMed 和 EMbase 的搜索。对已注册的试验进行分析，以了解临床状况、完成情况、阶段和研究的生物制剂。总结了最近完成的试验，并公布了结果。
从 2000 年到 2022 年，共有 365 项临床试验在 ClinicalTrials.gov 上注册，使用生物制剂治疗软骨修复和 OA。自 2006 年以来，注册试验的数量以每年 16.4%的速度加速增长。在 265 项指定为阶段的试验中，72%为早期 1 期、1 期和 2 期。软骨细胞和富血小板血浆（PRP）在早期和晚期试验中几乎数量相等。间充质干细胞/基质细胞（MSCs）是研究最多的生物制剂（38%），主要来源于骨髓和脂肪组织（70%）。在过去的 5 年中，72 项已完成试验中有 32 项公布了结果，其中 7 项 3 期试验研究了软骨细胞、PRP、骨髓抽吸物浓缩物、透明质酸、胶原膜和白蛋白。
近年来，注册临床试验的数量迅速增加，使用各种生物制剂治疗软骨修复和 OA。大多数生物制剂仍需要进行后期试验来验证其临床疗效。
