跳至主要内容
临床试验/EUCTR2010-022072-31-GB
EUCTR2010-022072-31-GB进行中(未招募)不适用

Autologous Cell Therapy for Osteoarthritis: An evaluation of the safety and efficacy of autologous transplantation of articular chondrocytes and/or bone marrow-derived stromal cells to repair chondral/osteochondral lesions of the knee. - Autologous Stem Cells, Chondrocytes or the Two? (ASCOT)

RJAH Orthopaedic Hospital0 个研究点目标入组 114 人开始时间: 2011年6月16日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
114

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

性别
All

入选标准

  • 1. A symptomatic chondral defect of the knee that extends to (Outerbridge grade 4) or into the subchondral bone.
  • 2. The defect is considered suitable for treating with autologous cell therapy.
  • 3. Previous surgical treatment of the defect has failed to relieve symptoms.
  • Are the trial subjects under 18? no
  • Number of subjects for this age range: 0
  • F.1.2 Adults (18-64 years) yes
  • F.1.2.1 Number of subjects for this age range 108
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 6

排除标准

  • 1. Positive for HIV, hepatitis B or C, syphilis, or human T cell lymphotrophic virus (HTLV) I or II.
  • 2. Likely to show contraindications to autologous cell therapy: patients with inflammatory condition, history of mesenchymal tumours, therapy with steroids or methotrexate, bleeding tendency or known anaphylaxis to any product used in cell preparation.
  • 3. Low probability of compliance with physiotherapy or follow-up, including a major life-threatening condition.

研究者

发起方
RJAH Orthopaedic Hospital

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