Autologous Cartilage Implantation: Safety Study for Focal Chondral Lesions in the Knee and the Ankle : Open Cohort, Small Sample Size With 12 Months Follow-Up
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 11
- 试验地点
- 5
- 主要终点
- Safety
研究概览
简要总结
The purpose of this study is to investigate the safety and feasibility of implanting autologous cartilage mini-grafts (or Cartibeads) into cartilage defects in the knee and ankle.
Cartibeads are engineered from autologous articular chondrocytes (from the patient's own cartilage cells). A small cartilage biopsy (~50 to 150 mg according to lesion size to be treated) is collected from a minimal weight bearing zone of the patient's articulation. Chondrocytes are extracted from the biopsy and expanded in culture. Our patented, standardized methodology then allows expanded cells to recover their capacity of producing hyaline matrix and to form cartilage mini-grafts (Cartibeads). These grafts are beads of 1 to 2 mm in diameter and have similar characteristics to native hyaline cartilage.
Autologous Cartibeads are implanted into the patient's cartilage defect. Patients are then followed for 12 months for assessment of study endpoints, with safety being the primary outcome.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Cartilage focal lesion(s) ≥ 1.5 cm2 and ≤ 10 cm2
- •ICRS grade 3 or 4
- •Pain for 3 months or more
- •Aged over 18 years
排除标准
- •Inability to undergo MRI
- •Cartilage specific surgery within 12 months from baseline
- •Cartilage therapeutic injection within 3 months from baseline
- •Radiologically apparent degenerative joint disease (K&L grade >1)
- •Chronic inflammatory arthritis and/or infectious arthritis
研究组 & 干预措施
Autologous Cartibeads
Implantation of autologous cartilage mini-grafts (Cartibeads)
干预措施: Implantation of autologous cartilage mini-grafts (Cartibeads) (Biological)
结局指标
主要结局
Safety
时间窗: From enrolment to the end of follow-up at 12 months
Recording, identifying, documenting and reporting all Serious Adverse Events (SAEs) and Adverse Events (AEs).
次要结局
未报告次要终点