ASCLEPIOS Autologous Stem CelL Expansion and Prospective Injection for Osteoarthritic Hip Symptoms
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Mayo Clinic
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Nature, incidence and severity of adverse events (AEs)
研究概览
简要总结
Will injection(s) of autologous culture-expanded AMSCs be safe and efficacious for treatment of painful Hip OA, and if so, which dosing regimen is most effective?
详细描述
This phase I study will enroll 24 subjects with mild to moderate osteoarthritis of the hip. Subjects will receive either a single dose of 30 million autologous culture-expanded adipose-derived mesenchymal stromal cells (AMSCs), or two doses of AMSCs (with one month interval between doses) via ultrasound guided intra-articular hip injection. Patients will be followed for 24 months past their last injection to determine the local and systemic safety of single and two-dose injections of AMSCs in the treatment of symptomatic hip OA.
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
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Single Injection
Single administration of Autologous Adipose Derived Mesenchymal Stromal Cells into the hip by single ultrasound guided injection
干预措施: Autologous Adipose Derived Mesenchymal Stromal Cells (Drug)
Two Injections
Two-dose administration (2 x ultrasound guided injections) of Autologous Adipose Derived Mesenchymal Stromal Cells into the hip with one month interval between doses
干预措施: Autologous Adipose Derived Mesenchymal Stromal Cells (Drug)
结局指标
主要结局
Nature, incidence and severity of adverse events (AEs)
时间窗: For a period of 2 years following last injection
Defined as any untoward or undesirable medical occurrence in the form of signs, symptoms, abnormal findings, or diseases that emerge or worsen relative to baseline (i.e., if present upon study entry) during the study regardless of causal relationship. Methods i. Spontaneous subject reports ii. Subject interview by study personnel iii. Clinical examination during face-to-face clinic follow-ups
次要结局
- Change in cartilage thickness(Baseline, 6 months, and 12 months post-treatment cycle)
- Change in radiographic joint morphology(Baseline, 6 months, and 12 months post-treatment cycle)
- Change in synovial fluid biomarkers within the target hip(Baseline at the time of AMSC injection, At time of second injection (1 month status post first injection) in 2-injection group)
- Change in Visual Analog Scale (VAS) for pain in the target hip following completion of treatment cycles(Baseline, 6 weeks, 6 months, 12 months post-treatment cycle)
- Change in modified Harris Hip Score (mHHS) in the target hip following completion of treatment cycles(Baseline, 6 weeks, 6 months, 12 months post-treatment cycle)
- Change in cartilage volume(Baseline, 6 months, and 12 months post-treatment cycle)
- Change in cartilage morphology(Baseline, 6 months, and 12 months post-treatment cycle)
- Change periarticular soft-tissues(Baseline, 6 months, and 12 months post-treatment cycle)
- Change in Tegner activity scale in the target hip following completion of treatment cycles(Baseline, 6 weeks, 6 months, 12 months post-treatment cycle)
- Change in Hip disability and osteoarthritis Outcome Score (HOS) in the target hip following completion of treatment cycles(Baseline, 6 weeks, 6 months, 12 months post-treatment cycle)
- Change in subchondral bone morphology(Baseline, 6 months, and 12 months post-treatment cycle)
研究者
Aaron Krych
Professor of Orthopedics
Mayo Clinic