A Clinical Trial Study Evaluating the Safety and Preliminary Efficacy of Human Induced Pluripotent Stem Cell-derived Extracellular Vesicles (iEVs) Injection for the Treatment of Lateral Epicondylitis of the Humerus
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Assess changes in pain levels using a Visual Analogue Scale (VAS)
研究概览
简要总结
Evaluate the safety and preliminary efficacy of human induced pluripotent stem cell-derived extracellular vesicle (iEV) injection in the treatment of lateral epicondylitis of the humerus.
详细描述
Lateral epicondylitis refers to pain at the lateral epicondyle of the humerus caused by chronic traumatic tendinopathic changes in the origin and insertion of the common extensor tendon on the lateral side of the elbow joint, which result from long-term and repeated loading.
This randomized controlled study aims to observe whether extracellular vesicles derived from human induced pluripotent stem cells (iEVs) can promote the improvement of inflammatory status in injured extensor tendons and alleviate clinical symptoms. The study design will evaluate the efficacy by assessing changes in patients' pain, grip strength, and elbow joint function after treatment with the injection, and compare the efficacy with that of the control groups.
This is an interventional, single-center clinical study. The study plans to adopt a block randomization method without stratification. A randomization list will be generated separately for each research center by a computer, and participants will be randomly assigned to the experimental group, positive control group, and negative control group. There will be 6-12 cases in the experimental group, and 3-6 cases in each of the two control groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (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
- •Diagnosed with lateral epicondylitis by clinical symptom examination and MRI or ultrasound, without obvious tendon tear;
- •Unilateral lateral elbow pain lasting for more than 12 weeks;
- •Pain is provoked by at least 2 of the following methods, with a pain VAS score exceeding 3: maximum grip strength, palpation of the lateral epicondyle of the elbow and surrounding area, resisted dorsiflexion of the wrist or middle finger, or stretching of the forearm extensor muscles under a pain-free grip state;
- •Having received physical therapy or non-steroidal anti-inflammatory drug treatment with poor efficacy;
- •Individuals with independent behavioral capacity, who have signed the informed consent form themselves.
排除标准
- •Complaints of ipsilateral muscle pain caused by other reasons in the past 6 months;
- •Presence of ipsilateral neurogenic, inflammatory, or systemic joint diseases;
- •A history of previous lateral epicondylitis (LET) surgery in the past 6 months;
- •Subjects deemed unsuitable for participating in the trial due to other conditions, as judged by the researcher;
- •MRI showing that the injury has involved the lateral collateral ligament, with concurrent cartilage damage.
研究组 & 干预措施
iEV-high
1X10^10/ml
干预措施: iEV (Biological)
iEV-high
1X10^10/ml
干预措施: immobilization (Other)
iEV-Low
1X10^9/ml
干预措施: iEV (Biological)
iEV-Low
1X10^9/ml
干预措施: immobilization (Other)
PRP
PRP
干预措施: PRP (Biological)
PRP
PRP
干预措施: immobilization (Other)
Control
干预措施: immobilization (Other)
结局指标
主要结局
Assess changes in pain levels using a Visual Analogue Scale (VAS)
时间窗: From enrollment to the end of treatment at 12 weeks
Assess changes in pain levels using the Visual Analogue Scale (VAS). The scale ranges from 0 (no pain) to 10 (the most severe pain), where a higher score indicates more severe pain (worse outcome) and a lower score indicates less severe pain (better outcome).
Evaluate changes in functional outcomes through patient-rated tennis elbow assessments (PRTEE)
时间窗: From enrollment to the end of treatment at 12 weeks
To assess changes in functional outcomes, the Patient-Rated Tennis Elbow Evaluation (PRTEE) is utilized. This scale encompasses 15 items, divided into two dimensions: the pain dimension (5 items) and the function dimension (10 items). It uses a 0-10 scoring system, where a higher total score indicates more severe functional impairment (worse outcome), and a lower total score indicates less severe functional impairment (better outcome).
Assess changes in functional outcomes using the Mayo Elbow Performance Score (MEPS)
时间窗: From enrollment to the end of treatment at 12 weeks
To assess changes in elbow function, the Mayo Elbow Performance Score (MEPS) is employed. This scale ranges from 0 to 100, where a higher score indicates better elbow function (better outcome) and a lower score indicates worse elbow function (worse outcome).
Incidence of adverse events
时间窗: From enrollment to the end of treatment at 12 weeks
次要结局
- Changes in the results of the SF-36 Quality of Life Questionnaire(From enrollment to the end of treatment at 12 weeks)
- Changes in functional outcomes assessed by the Subjective Elbow Value (SEV)(From enrollment to the end of treatment at 12 weeks)
- MRI imaging assessment at 3 months after injection(From enrollment to the end of treatment at 12 weeks)
研究者
Jian Ding
Doctor
Shanghai 6th People's Hospital