A 16-week single-arm pilot study on the safety and efficacy of an Intra-articular filler, HP cell Vitaran J in the Knee affected by Osteoarthritis.
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 46
研究概览
简要总结
Results There were 51 participants in all, and 5 people with missing values were excluded from the analysis of the results. The statistically significant difference between medial and lateral compartment bone structure value (BSV) was noticed in all layers. Medial BSV was higher than lateral BSV. The statistically significant difference between medial and lateral BSV was disappeared in middle and deep layers after polynucleotide (PN) injection. BSV difference between medial and lateral compartment remained in superficial layer. Which can indicated micro-structural changes in middle and deep layer after PN treatment. The VAS and K-WOMAC score at the last injection (6 weeks after screening visit) was improved than screening visit. These improvements remained over the study process until last follow up. Conclusion In this study, we confirmed functional improvement of PN filler treatment in knee osteoarthritis (OA) patients . Also we confirmed anatomical improvement after PN filler treatment in knee OA patients by automated AI algorithm based texture analysis. Further researches developing our hypothesis on theoretical base of BSV analysis and mechanism of PN effecting BSV values should be proceeded.
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 40?(Year) 至 80?(Year)（—）
- 性别
- All
入选标准
- •1)Male and female adults aged = 40 and < 80
- •2)Voluntarily signed the written informed consent form
- •3)Ability to understand and comply with the study procedures and visit schedule
- •4)Diagnosis of arthritis according to the American College of Rheumatology (ACR) classification criteria at the screening visit
- •5)Kellgren-Lawrence Grade of II to IV for the severity of arthritis based on a knee X-ray at the screening visit
- •6)Visual Analogue Scale (VAS) at rest score of = 40 mm at the screening visit
- •7)Women of childbearing potential who has agreed to use a contraception method throughout the study
排除标准
- •1)Intra-articular injection to the knee within 6 months prior to screening
- •2)History of a knee surgery
- •3)Other diseases (presence or prior history of an autoimmune disease, myocardial infarction, cardiac arrest, severe heart disease, or uncontrolled hypertension) that may affect or interfere with the therapeutic effect
- •4)Chronic inflammatory diseases such as rheumatoid arthritis
- •5)Use of non-steroidal anti-inflammatory drugs (NSAIDs) within 48 hours prior to screening
- •6)Use of immunosuppressants such as cyclosporine A or azathioprine within 6 weeks prior to screening
- •7)Orthopaedic diseases that may affect or interfere with the therapeutic effect
- •8)Habitual use of psychotropic or narcotic analgesics for = 1 week within 8 weeks prior to screening
- •9)Psychological or psychiatric disorders that may affect a subject's participation in the study
- •10)More severe pain in other areas of the body than in the knee bone and joint at the screening visit
- •11) Ligament instability of = Grade II on the physical examination at the screening visit (Grade 0: no; Grade I: 0 - 5 mm; Grade II: 5 - 10 mm; Grade III: >10 mm)
- •12)Skin abnormalities such as infection or skin disease on the injection site
- •13)Pregnant or breastfeeding women (Women of childbearing potential must have a pregnancy test and cannot participate in the study if they are planning for pregnancy or are unwilling to use appropriate contraception methods.)
- •14)Participated in other intervention studies within 30 days prior to screening
- •15)Inability to communicate or follow instructions
- •16)Determined to be ineligible for the study by the investigator