Implantation of Allogenic Cartilage Mini-grafts: First-In-Human Study for Treating Chondral Lesions of the Knee. Open Cohort, Small Sample Size with 6 Months Follow-Up
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 10
- 试验地点
- 4
- 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 allogeneic cartilage mini-grafts (or allogenic Cartibeads) into cartilage defects in the knee.
Allogeneic Cartibeads are engineered from allogeneic articular chondrocytes (from a donor's cartilage cells). The donor, who in 2022 participated in the Autologous Cartibeads clinical trial (Swissmedic ID 701146), consented to use his leftover cells for production of mini-grafts for other patients in this study. Our patented, standardized methodology allows production of bead-shaped mini-grafts (Allogeneic Cartibeads). These grafts are 1 to 2 mm in diameter and have similar characteristics to native hyaline cartilage.
Allogeneic Cartibeads are implanted into the patient's cartilage defect. Patients are then followed for 6 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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Allogeneic Cartibeads
Implantation of allogeneic cartilage mini-grafts (Allogeneic Cartibeads)
干预措施: Implantation of allogeneic cartilage mini-grafts (Allogeneic Cartibeads) (Biological)
结局指标
主要结局
Safety
时间窗: From enrolment to the end of follow-up at 6 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