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临床试验/NCT01503970
NCT01503970已完成1 期

Autologous Chondrocyte Transplantation For Articular Cartilage Regeneration. Pilot Study

Instituto Nacional de Rehabilitacion2 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2008年12月最近更新:
适应症

试验速览

阶段
1 期
状态
已完成
入组人数
10
试验地点
2
主要终点
Change from baseline to different periods in T2 Mapping for cartilage lesions after treatment.

研究概览

简要总结

The purpose of this study is to assess safety and efficacy of autologous chondrocyte implantation delivered arthroscopically into chondral lesions of the knee using clinical, biochemical, and MRI outcomes.

详细描述

Injuries to the articular cartilage of the knee are common. They produce pain and deteriotation of patients' quality of life. The management of focal chondral lesions continues to be problematic for the treating orthopaedic surgeon. Although many treatment options are currently available, none fulfill the criteria for an ideal repair solution: a hyaline repair tissue that completely fills the defect and integrates well with the surrounding normal cartilage. Autologous chondrocyte implantation is a relatively new cell-based treatment method for full-thickness cartilage injuries that in recent years has increased in popularity, with different studies showing promising results. Typically, this implantation is performed in an open-surgery fashion. In our study the implantation of in-house autologous chondrocyte culture is done arthroscopically, situation that may offer advantages in surgery associated morbidity and patient recovery.

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 50 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • Patients with symptomatic chondral lesions of the knee

排除标准

  • Inflammatory arthritis
  • Septic arthritis
  • Total meniscectomy
  • Previous microfracture at chondral lesions
  • Ochronosis
  • Acromegalia

结局指标

主要结局

Change from baseline to different periods in T2 Mapping for cartilage lesions after treatment.

时间窗: 3, 6, 9, 12, 18, 24 36 months

Special magnetic resonance imaging technique for measurement of collagen and water content, it is expressed in milliseconds.

次要结局

  • Change of baseline to different periods in Clinical evaluation(0, 10, 30 days, 3, 6, 9, 12, 24, 36 months)

研究者

申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Aldo Izaguirre

Study Director

Instituto Nacional de Rehabilitacion

研究点 (2)

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