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

Robert Jones and Agnes Hunt Orthopaedic Hospital (UK)0 个研究点目标入组 114 人开始时间: 2013年9月16日最近更新: 2024年3月25日

适应症

试验速览

暂无简介。

•1. A symptomatic defect of the knee that extends to (Outerbridge grade 4) or into the subchondral bone
•2. The patient will be aged between 18 and 80 years at the time of surgery
•3. The defect is considered suitable for ACI
•4. Surgical treatment has been performed on the same defect at least 6 months previously and has failed to relieve symptoms
•5. The patient is able to provide written informed consent to participate in the trial

•1. English is not the first language of the patient
•2. Likely to show contraindications to autologous cell therapy:
•2.1. Osteoarthritis
•2.2. Inflammatory arthritis
•2.3. Previous or current malignant tumour
•2.4. Therapy with steroids or methotrexate
•2.5. Bleeding tendency or known anaphylaxis to any product used in chondrocyte preparation
•3. Low probability of compliance with physiotherapy or follow-up, including a major life threatening condition
•4. A defect of greater than 20cm2 in total area
•5. The patient is shown to be positive for serology tests required by the cell provider. This includes:
•5.2. Hepatitis B and C
•5.3. Syphilis
•5.4. Human T cell lymphotrophic virus (HTLV) I & II
•6. Pregnancy or lactation
•7. Exclusion criteria (5) and (6) will not be confirmed until after written informed consent is obtained

发起方

Robert Jones and Agnes Hunt Orthopaedic Hospital (UK)