A Prospective Single-Center Clinical Study of a Single Intra-Articular Injection of Autologous Protein Solution ("APS(TM)") in Patients With Osteoarthritis (OA) of the Knee
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- Number of Adverse Events
研究概览
简要总结
This prospective single-center study will evaluate the safety and tolerability of a single dose of "APS(TM)" treated patients with OA of the knee who have failed conservative OA therapy. The study will also evaluate efficacy by assessing patient pain and functionality.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Eligibility Criteria:
- •Male or female ≥40 years.
- •Willingness and ability to comply with the study procedures and visit schedules and ability to follow verbal and written instructions.
- •A standing radiograph of the knee showing a Kellgren grade of 2 or 3
- •Frequency of knee pain on most days over the last month.
- •Diagnosis of unilateral knee OA
- •Body mass index (BMI) ≤40 kg/m
- •Failed conservative OA therapy.
- •Signed an independent ethics committee (IEC)-approved informed consent form (ICF).
- •Willingness to abstain from the use of topical pain therapies, intra-articular corticosteroids, and viscosupplementation during the study.
- •Willingness to abstain from systemic pain medications except rescue medication.
排除标准
- 未提供
研究组 & 干预措施
Autologous Protein Solution "APS(TM)"
Patients who have been treated with a single, intra-articular injection.
干预措施: Autologous Protein Solution "APS(TM)" (Device)
结局指标
主要结局
Number of Adverse Events
时间窗: Up to 6 months post-injection
Safety and tolerability will be assessed from AEs and injection-site reactions, physical examinations, knee examinations, vital signs, ECGs, and clinical laboratory tests (hematology, coagulation, blood chemistry, and urinalysis) evaluated at baseline (pre-injection) and post-injection up to 6 months.
次要结局
- Number of Patients Using Rescue Medication(Up to 6 months post-injection)
- Pain Score(Baseline, Week 1, Week 2, and at Months 1, 3, and 6.)
- Stiffness Score(Baseline, Week 1, Week 2, and at Months 1, 3, and 6.)
- Physical Function Score(Baseline, Week 1, Week 2, and at Months 1, 3, and 6.)