ACTRN12615000257561撤回2 期
The evaluation of autologous adipose derived mesenchymal stem cells in combination with arthroscopic microfracture as treatment for symptomatic hip osteoarthritis on pain, function and cartilage volume in osteoarthritis patients.
Magellan Stem Cells0 个研究点目标入组 50 人开始时间: 2015年3月19日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- 入组人数
- 50
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •Inclusion Criteria :
- •1.Radiological diagnosis of a hip cartilage lesion.
- •2.Primary treatment already undertaken defined as: analgesia/anti-inflammatory medication, supplements approved by the treating clinician (eg glucosamine sulphate), an attempted exercise program prescribed by a physiotherapist or medical practitioner for at least 8 weeks (Petrella 2000), weight loss and nutritional management as prescribed by a dietician or medical practitioner for at least 8 weeks, and biomechanical management including bracing if appropriate as prescribed by a physiotherapist, podiatrist or medical practitioner. Autologous MSC is an invasive treatment and guidelines recommend trialling conservative measures as the first line of treatment (Thompson, Gordon et al. 2009).
- •3.Sufficient English skills to complete the questionnaires required for the study, as well as to understand the instructions given by the study doctors. This is required as no funding is available for translation or interpreters, and the outcome questionnaires to be used have only been validated in English language.
排除标准
- •Exclusion Criteria:
- •1.Age <18yrs. OA does not commonly occur in people under 18.
- •2.Pregnancy (accepted contra-indication as no safety data on this population).
- •3.Breastfeeding (accepted contra-indication as no safety data on this population).
- •4.Have other causes of their ankle symptoms suspected to be due to serious pathology such as tumour or referral from the lumbar spine. These conditions are not under investigation within the current project.
- •5.Current cancer.
- •6.History of significant organ impairment/failure (ie. renal failure).
- •7.History of allergy to any substances used within the treatments.
- •8.Bovine allergy
研究者
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