A Double-Blind Randomised Placebo-controlled Phase IIb Clinical Trial to Study the Efficacy & Safety of a Novel Platelet Lysate Gel in the Treatment of Lateral Epicondylitis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Pain free grip strength
研究概览
简要总结
Current treatments for lateral epicondylitis include: rest, behaviour modification and physiotherapy, anti-inflammatory medication - both steroidal and non-steroidal, and surgery. Current experimental therapies include muscle relaxants to reduce muscle tone and force on the epicondyle, laser therapy to stimulate collagen production, and blood based therapies including the injection of autologous blood and protein rich plasma.
Cell Therapy Ltd (trading as Celixir) has developed a regenerative gel that combines isolated allogeneic platelet growth factors and a cellulose-derivative gel.
详细描述
Lateral epicondylitis, also called "tennis elbow" is a common condition affecting 1 to 3% of the population; most commonly individuals aged 35 to 55 years. It is frequently self limiting but can lead to refractory symptoms in a minority of cases. Pain is localised to the lateral epicondyle of the elbow at the point of insertion of the common extensor tendon. Although associated with repetitive movement of the extensor muscles of the forearm, frequently no precipitating cause can be discerned.
The term "epicondylitis" is a misnomer as histological investigations have revealed that there is only limited inflammation, and the term "epicondylosis" should be employed, due to the degenerative nature of the condition.
The condition is divided in to 4 stages, though progression may not occur through all four. Firstly, there is acute inflammation that is quick to resolve. Secondly, prolonged injury results in an increase in fibroblasts, vascular hyperplasia, disorganised collagen disposition and degeneration of the tendon. Thirdly, further accumulation of structural alterations leads to partial or complete tendon rupture. Stage 4 exhibits the same features as 2 and 3 but with the addition of calcification.
Current treatments for lateral epicondylitis include: rest, behaviour modification and physiotherapy, anti-inflammatory medication both steroidal and non-steroidal, and surgery. Current experimental therapies include muscle relaxants to reduce muscle tone and force on the epicondyle, laser therapy to stimulate collagen production, and blood based therapies including the injection of autologous blood and protein rich plasma. Trials of the latter two treatments give conflicting results due to variations in protocol and trial design.
Cell Therapy Ltd has developed a regenerative gel, Tendoncel, that combines isolated platelet growth factors and cellulose-derivative gel. Tendoncel consists of a proprietary platelet lysate formulation that is easy to apply to the skin.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects aged 18 years and over and in good general health
- •Subjects who have a diagnosis of lateral epicondylitis, Cozen's test
- •Subjects who are willing to attend all study assessments and follow-up appointments
- •Subjects who are able to understand the study, and are willing to co-operate with the study procedures and restrictions
排除标准
- •Subjects have been receiving additional concurrent treatment (e.g. surgical or steroid injection) for lateral epicondylitis.
- •Subjects who have medial epicondylitis or another condition of the elbow (test side only)
- •Subjects who have participated in any clinical study during the previous 30 days of initiation of this study
- •Subjects with a history of alcohol, substance or drug abuse in the previous 12 months
- •Subjects with any significant concurrent illness
- •Subjects with a heart pacemaker
- •Subjects with diabetes either type I or type II (owing to possible poor wound healing)
- •Subjects that have undergone surgery in the past 3 months
- •Subjects with any active or significant history of skin disorders at the treatment area(s) e.g. hypo pigmentation (vitiligo)
- •Subjects with any inflammatory skin condition (eczema, psoriasis, herpes simplex/complex)
- •Subjects with a history (or family history) of skin cancer, skin tumours or any other malignant disease
- •Subjects with any irritation, tattoo's, piercings, scars, birthmarks, or heavy presence of freckles at the treatment site(s)
- •Subjects currently taking anti-histamine or steroid medication
- •Subject who due to impaired mobility would not be able to undertake independent care
- •Subjects who are pregnant or who are breast feeding.
结局指标
主要结局
Pain free grip strength
时间窗: Mean of 47 weeks follow up (final follow up).
Measured using a dynamometer. Results compared between test and control elbows, and between study and contralateral elbow (internal control).
Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire
时间窗: Mean of 47 weeks follow up.
30 question questionnaire measuring disabilities of the upper limb. Scale from 0 to 100 (best to worst). Difference between test and control scores compared.
Patient-Rated Tennis Elbow Evaluation (PRTEE) questionnaire
时间窗: Mean of 47 weeks follow up.
15 question questionnaire measuring pain and function. Total scores from 15 questions compared - pain and function combined. Scale: 10 to 100 (best to worst). Difference between test and control scores compared.
次要结局
- Safety: Immune response - blood IgE levels. Number of participants in each group with a normal baseline reading and a subsequently elevated reading.(Baseline, day 7 and day 23.)
- Safety - Number of participants in each group with adverse events.(Day 3 (1st treatment visit), day 7, day 14, day 21, day 23 (end of treatment). Follow ups: 4 weeks, 6 weeks, 3 months and mean of 47 weeks.)
- Safety: Immune response - blood IgE levels. Difference between test and control groups.(Day 23)