CTIS2023-504212-15-00进行中（未招募）1 期
A phase I/IIa, prospective, mono-center, double-blinded, randomized, controlled study to assess the safety and efficacy of applying PLX-PAD cells for the treatment of mild to moderate knee osteoarthritis - PROTO
Charite Universitaetsmedizin Berlin KöR0 个研究点目标入组 132 人开始时间: 2023年11月24日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 132
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 65+（—）
- 性别
- All
入选标准
- •Signed written informed consent prior to initiation of any trial related measure., Adult patients (f/m), 50 to 80 years old at the time of the screening visit, Symptomatic mild to moderate OA of the index knee as defined by the OARSI-Joint Space Narrowing (JSN) Score of 1or 2 (standing Rosenberg AP x-ray), Pain in the index knee of 8-18 on the WOMAC pain score (reporting the last 48 hours, respectively at week 4 and week 1 before inclusion) after washout of at least 5 half-lives of previously taken NASAIDs medication(s), Failed conservative treatment, indicated by Pain in the index knee = 3 months due to OA
排除标准
- •Arthroscopy to the index knee within the last 12 months as well as surgery to other weight-bearing joints, that may interfere with index knee assessments, Prior reconstructive cartilage transplantation or resurfacing procedures to the index knee, Knee instability of clinical relevance such as lateral, medial or cruciate ligament instabilities that compromise patient during walking at time of screening, Patients having received OA knee injection therapy (such as PRP, MSCs, or Hyaluronic Acid) in the last six months before screening, Rheumatologic inflammatory arthropathies
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