A First-in-Human Open-Label Phase 1/2a Study to Evaluate Safety, Tolerability and Efficacy of a Single Intra-Articular Injection of Allogeneic Mesenchymal Stem Cells Selected for Integrin α10β1 (XSTEM-OA) in Adult Patients With Symptomatic Knee Osteoarthritis
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Safety and tolerability: 12-lead electrocardiogram (ECG)
研究概览
简要总结
The aim of the study is to assess safety, tolerability and preliminary efficacy of XSTEM-OA when administered as a single intra-articular injection to patients with symptomatic knee osteoarthritis. The study is divided into two parts; a dose escalation (Part A) and an optional dose expansion part (Part: B). Three dose levels are planned to be evaluated in Part A and selected dose level(s) may be further expanded in Part B.
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 75 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
XSTEM-OA
Single intra-articular injection of XSTEM-OA
干预措施: XSTEM-OA (Biological)
结局指标
主要结局
Safety and tolerability: 12-lead electrocardiogram (ECG)
时间窗: From start of study until 18 months after injection
Change in 12-lead electrocardiograms (ECGs) compared to baseline.
Safety and tolerability: Laboratory examinations
时间窗: From start of study until 18 months after injection
Changes in laboratory tests compared to baseline. The clinical laboratory tests include haematology, chemistry, coagulation and urinalysis.
Safety and tolerability: Physical examinations
时间窗: From start of study until 18 months after injection
Changes in physical examination compared to baseline.
Safety and tolerability: Vital signs
时间窗: From start of study until 18 months after injection
Changes in vital signs compared to baseline. Vital signs include blood pressure, pulse rate, respiratory rate and oral body temperature.
Safety and tolerability: Adverse events (AEs)
时间窗: From start of study until 24 months after injection
Incidence, nature and severity of treatment-related AEs assessed by the Common Terminology Criteria for Adverse Events (CTCAE)
次要结局
- Preliminary efficacy: Changes in Visual Analogue Scale (VAS) for pain compared to baseline(From start of study until 18 months after injection)
- Preliminary efficacy: Change in cartilage structure and morphology compared to baseline, based on MRI assessment of cartilage volume and composition(From start of study until 18 months after injection)
- Preliminary efficacy: Change in whole knee health compared to baseline, based on MRI assessment by the MRI Osteoarthritis Knee Score (MOAKS)(From start of study until 18 months after injection)
- Preliminary efficacy: Change in inflammatory activity compared to baseline, based on MRI assessment of synovitis(From start of study until 18 months after injection)
- Preliminary efficacy: Change in EuroQoL 5 Dimension 5 Level test (EQ-5D-5L) compared to baseline(From start of study until 18 months after injection)
- Preliminary efficacy: Change in 40 m fast paced walk test compared to baseline(From start of study until 18 months after injection)
- Preliminary efficacy: Changes in joint space narrowing based on x-ray compared to baseline(From start of study until 18 months after injection)
- Preliminary efficacy: Changes in Knee injury and Osteoarthritis Outcome Score (KOOS) compared to baseline(From start of study until 18 months after injection)