Gupta Ashim
Future Biologics, Lawrenceville, GA 30043, USA.
BioIntegrate, Lawrenceville, GA 30043, USA.
Pharmaceuticals (Basel). 2022 Mar 26;15(4):404. doi: 10.3390/ph15040404.
Osteoarthritis (OA) impacts millions of people and places a high burden on healthcare systems in the United States. Current treatment modalities have limitations and do not address underlying pathology. Lately, there has been an immense growth in the use of biologics, including perinatal allogenic tissues for orthopedic regenerative medicine applications. Amniotic tissue is an exciting new alternative for such applications. Despite several published studies that reported its use for treatment of ophthalmic conditions and complex wounds, there are limited clinical studies evaluating its safety and efficacy in treating patients suffering with knee or hip OA. In this manuscript, I focused on three prospective clinical studies which evaluated the safety and efficacy of amniotic tissue in patients suffering with moderate knee or hip OA. The results from these studies presented the scientific community with much needed, well-executed, and prospective clinical trials. Though these trials demonstrated that administration of amniotic tissue in knee or hip joint is safe and potentially effective, more multi-center, prospective, double-blinded, randomized controlled trials are warranted to further establish the efficacy of amniotic tissue to mitigate symptoms of knee and hip OA to ultimately justify its clinical use.
骨关节炎(OA)影响着数百万人,给美国的医疗保健系统带来了沉重负担。目前的治疗方式存在局限性,无法解决潜在的病理问题。最近,生物制品的使用有了巨大增长,包括用于骨科再生医学应用的围产期同种异体组织。羊膜组织是此类应用中一种令人兴奋的新选择。尽管有几项已发表的研究报告了其用于治疗眼科疾病和复杂伤口的情况,但评估其治疗膝或髋骨关节炎患者安全性和有效性的临床研究却很有限。在本手稿中,我重点关注了三项前瞻性临床研究,这些研究评估了羊膜组织治疗中度膝或髋骨关节炎患者的安全性和有效性。这些研究结果为科学界提供了急需的、执行良好的前瞻性临床试验。尽管这些试验表明在膝关节或髋关节中施用羊膜组织是安全且可能有效的,但仍需要更多的多中心、前瞻性、双盲、随机对照试验来进一步确定羊膜组织缓解膝和髋骨关节炎症状的疗效,以最终证明其临床应用的合理性。