A Multi-center, Randomized, Independent Evaluator-blinded, Subject-blinded, Placebo-controlled, Phase 1/2 Clinical Study to Evaluate Safety and Efficacy of TPX-115 in Patients With Partial-Thickness Rotator Cuff Tear
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 49
- 试验地点
- 4
- 主要终点
- Change in shoulder score of American Shoulder and Elbow Surgeons (ASES)
研究概览
简要总结
Rotator cuff tear is one of the most common shoulder diseases and conservative treatment is commonly used for tears involving ≤50% of tendon thickness. Since conventional conservative treatments are not fundamental to repair tendon tissue, there is a growing need of new therapy to improve structural outcome. This study assesses the safety and efficacy of allogeneic fibroblasts on partial-thickness rotator cuff tear. The primary outcome is change in American Shoulder and Elbow Surgeons (ASES) score at 24 weeks after TPX-115 injection. Secondary outcomes include changes from baseline in Visual Analogue Score (VAS) pain score, functional evaluations including Range of Motion (ROM), Constant Score (CS), ASES score and Simple Shoulder Test (SST) at 4, 12 and 24 weeks after administration and structural evaluation using MRI at 24 weeks after injection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants must;
- •Be 19 years of age or older.
- •Have partial-thickness rotator cuff tear, ≤50% of tendon thickness or of Ellman grade I, II assessed by MRI.
- •Have unilateral shoulder pain lasting more than 3 months despite conservative treatment and VAS pain score ≥5 at screening.
- •Understand fully the study and voluntarily sign the informed consent for participation in the study.
排除标准
- •Participants with any of the following conditions will be excluded unless stated otherwise;
- •Have partial-thickness rotator cuff tear larger than 50% of tendon thickness or of Ellman grade III, or full-thickness rotator cuff tear confirmed by MRI.
- •Have prior medical history of shoulder surgery on the torn rotator cuff or the upper part of shoulder within 6 months prior to screening visit (shoulder trauma, fracture, upper cervical spine surgery, etc.).
- •Have had subacromial or intra-articular injections on the affected shoulder within 3 months prior to screening visit.
- •Have had received systemic steroid or immunosuppressive agents within 4 weeks prior to screening visit.
- •Have been diagnosed with the following diseases.
- •Inflammatory joint diseases
- •Other shoulder diseases which may cause shoulder pain or functional disorder
- •Autoimmune diseases
- •Active hepatitis B or C
- •HIV Ab positive
- •Malignant tumors within the last 5 years
- •Coagulopathy
- •Genetic disorders related to fibroblasts of collagen
- •Other serious diseases deemed to affect the results of the study
- •Have allergies to bovine proteins or gentamicin.
- •Be pregnant, breastfeeding, planning pregnancy or unwilling to use of contraceptive suggested in this study.
- •Have participated in other clinical trials and received investigational agents within 4 weeks of this study
- •Be deemed inadequate for the study by investigators.
结局指标
主要结局
Change in shoulder score of American Shoulder and Elbow Surgeons (ASES)
时间窗: 24 weeks
ASES shoulder score is derived from the Visual Analogue Scale (VAS) score for pain and activities of daily living score. The total score - maximum of 100 points - is weighted 50% for pain and 50% for function.
次要结局
- Change in tear/footprint on MRI(24 weeks)
- Change in shoulder score of American Shoulder and Elbow Surgeons (ASES)(4, 12 weeks)
- Change in Range of Motion (ROM)(4, 12, 24 weeks)
- Change in pain score of Visual Analogue Scale (VAS)(4, 12, 24 weeks)
- Change in Constant score (CS)(4, 12, 24 weeks)
- Change in Simple Shoulder Test (SST) Score(4, 12, 24 weeks)
- Change in tear size on Magnetic Resonance Image (MRI)(24 weeks)
- Change of tendinosis on MRI(24 weeks)
- Change in tendon thickness on Magnetic Resonance Image (MRI)(24 weeks)