ACTRN12615000769583尚未招募1 期
A parallel, interventional study to evaluate the efficacy of current products utilizing participant’s adipose tissue (Lipogems technique) and participant’s blood extracts (Orthokine or Platelet-Rich-Plasma) in combination with injections of human peptide derivatives for the treatment of moderate to severe knee osteoarthritis.
Mastercell Stem Cell Centre0 个研究点目标入组 45 人开始时间: 2015年7月24日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 45
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
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 70 Years(—)
- 性别
- All
入选标准
- •Patients who give written consent to participate in the study.
- •Radiological diagnosis of knee osteoarthritis with Kellgren-Lawrence grades 3 - 4 (Patients will need to have imaging findings (radiography or magnetic resonance imaging) that show degenerative changes).
- •Concurrent disease medically stable
排除标准
- •inability to give informed consent
- •Known allergies/ hypersensitivities to local anaesthetics or antibiotics
- •Any illness which, in the Investigator's judgment, will interfere with the patient's ability to comply with the protocol, compromise patient safety, or interfere with the interpretation of the study results
- •Females who are pregnant (detected by urinary hCG in fertile women) or lactation or females of childbearing potential who are unwilling to maintain contraceptive therapy for the duration of the study.
- •Anti-coagulant use (as below) that cannot be stopped or bleeding disorders (no use of Warfarin, Aspirin, Vitamin E, fish oil or anti-inflammatory medications 10 days before treatment)
- •Active or chronic infectious disease including infection with HIV1-2 or chronic Hepatitis B or Hepatitis C. For patients who have tested positive, an expert will be consulted as to patient eligibility based on the patient's infectious status
- •Immunosuppressed
- •History of cancer (other than non-melanoma skin cancer or in-situ cervical cancer) in the last five years.
- •Morbid Obesity
- •Any surgical implant in the knee (plates, pins, rods, screws, prosthesis).
- •Restricted to a wheel chair due to any other condition apart from Osteoarthritis.
研究者
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