A Multi-center, Randomized, Double Blinded, Placebo-controlled, Phase 2b/3 Clinical Trial to Evaluate the Safety and Efficacy of TPX-115 in Patients With Partial-thickness Rotator Cuff Tear
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 166
- 试验地点
- 4
- 主要终点
- Change in shoulder score of Constant score (CS)
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 Constant Score (CS) at 24 weeks after TPX-115 injection. Secondary outcomes include changes from baseline in CS, Visual Analogue Score (VAS) pain score, American Shoulder and Elbow Surgeons (ASES) score, Quick Disabilities of the Arm, Shoulder and Hand (Quick-DASH), Simple Shoulder Test (SST), and functional evaluations including Range of Motion (ROM) at 4, 12, 24 and 52 weeks after administration and structural evaluation using MRI at 24 and 52 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
- •Be 19 years of age or older.
- •Have partial-thickness rotator cuff tear, ≤50% of tendon thickness or of Ellman grade II assessed by MRI.
- •Have unilateral shoulder pain, muscle weakness and limited active range of motion lasting more than 3 months despite conservative treatment
- •VAS pain score ≥4 at screening.
- •Understand fully the study and voluntarily sign the informed consent for participation in the study.
排除标准
- •Regardless of partial-thickness rotator cuff tear, have full-thickness rotator cuff tear confirmed by MRI.
- •Have been treated with the following
- •Have had painkiller within 1 week prior to screening visit.
- •Have had received systemic steroid or immunosuppressive agents within 4 weeks prior to screening visit.
- •Have had subacromial or intra-articular injections on the affected shoulder within 3 months prior to screening visit.
- •Have shoulder surgery on the rotator cuff tear or had received drug that included growth factor, within 6 months 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 Constant score (CS)
时间窗: 24 weeks
The CS total score (100) = Pain (15) + Activity of Daily Living (20) + Mobility (40) + Strength(25)
次要结局
- hange in pain score of Visual Analogue Scale (VAS)(4, 12, 24, 52 weeks)
- Change of tendinosis on MRI(24, 52 weeks)
- Change in shoulder score of Constant score (CS)(4, 12, 52 weeks)
- Change of American Shoulder and Elbow Surgeons (ASES) Shoulder Score(4, 12, 24, 52 weeks)
- Change of Quick Disabilities of the Arm, Shoulder and Hand (Quick-DASH) Outcome Measure(4, 12, 24, 52 weeks)
- Change in Simple Shoulder Test (SST) Score(4, 12, 24, 52 weeks)
- Change in Range of Motion (ROM)(4, 12, 24, 52 weeks)
- Change in Ellman grade on Magnetic Resonance Image (MRI)(24, 52 weeks)