Clinical Study on the Safety and Efficacy of Tendon Stem Progenitor Cells Therapy for Rotator Cuff Tears
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 107
- 主要终点
- Phase I：Incidence and severity of cell therapy related adverse events
研究概览
简要总结
Tendon injury is one of the most common sports injuries, including local tissue degeneration at the tendon insertion site following inflammation caused by long-term joint movement, friction, or strain, as well as acute traumatic tendon tears and defects of varying degrees due to sports. It is a recognized therapeutic challenge in orthopedics and sports medicine. With the increase in people's physical activities and changes in work styles, tendon injuries have become increasingly prevalent, with at least 30 million tendon injury cases annually. Meanwhile, tendon injuries pose a significant threat to the careers of many elite athletes. Currently, clinical treatments for tendon injuries mainly remain at the stages of physical therapy, surgical suture, and transplantation. Although these treatments have certain effects, their efficacy is limited-primarily because adult tendons lack complete regenerative capacity. As a result, the quality of repaired tendons is far inferior to that of normal tendons, making them prone to tendon adhesion, poor structural and mechanical properties, and frequent re-rupture. Even autologous tendon transplantation can only achieve approximately 40% of the mechanical properties of normal tendons, accompanied by excessive scar tissue formation. Current therapeutic and tissue engineering approaches can only partially improve tendon repair quality, failing to induce complete tendon repair and regeneration. Therefore, exploring new and efficient strategies for the treatment and regeneration of tendon injuries is of great significance.
In recent years, cell therapy has brought new opportunities for improving the repair quality of soft tissues such as tendons. Tendon-derived cells are isolated and extracted from tendons. These cells not only possess stem cell characteristics similar to bone marrow mesenchymal stem cells but also highly express tendon-specific genes and proteins. Therefore, this study intends to first culture and expand tendon stem/progenitor cells (TSPCs) to form therapeutic agents, then apply TSPC-enhanced therapy intraoperatively to patients with rotator cuff tendinopathy, and evaluate its clinical safety and efficacy.
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, Outcomes Assessor)
盲法说明
In phase II clinical trial, blinding will be applied to the participants, those measuring the intervention effects, and the statistician responsible for the analysis. The operating surgeons will not be blinded. Sequentially numbered, sealed opaque envelopes containing group allocation information will be provided to the operating surgeons. Group allocation concealment will be ensured through the use of a central automated randomization system, and security measures will be implemented to prevent those blinded from accessing or influencing the allocation data. Objective measurements of rotator cuff structural changes and pain will be performed by trained assessors unaware of the group assignments. The statistician conducting the statistical analysis will also remain blinded.
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged between 18 and 70 years, regardless of gender;
- •Tear size classified as small (< 1 cm) or medium-sized (1 cm to 3 cm) according to the DeOrio and Cofield classification system;
- •Persistent shoulder pain or functional limitations despite at least 3 months of non-surgical treatment, with indications for arthroscopic rotator cuff repair;
- •Willing to sign the informed consent form and agree to participate in this study.
排除标准
- •Tear size classified as large (3 cm to 5 cm) or massive (> 5 cm) according to the DeOrio and Cofield classification, or Patte grade 3 tendon retraction;
- •Subscapularis tendon tear;
- •Complicated with anterior, posterior, or multidirectional shoulder joint instability;
- •Indications for repair of anterior or posterior labral injury;
- •Intra-articular injection of hyaluronic acid or corticosteroids within 3 months prior to the planned surgery;
- •Comorbidities that contraindicate arthroscopic shoulder surgery;
- •Local (shoulder, abdomen, buttocks) or systemic infection, osteomyelitis, or sepsis;
- •Diabetes mellitus, untreated thyroid disease, chronic kidney disease, or rheumatoid arthritis;
- •Immunodeficiency;
- •Chronic diseases involving coagulation or platelet aggregation, or severe coagulopathy;
- •Severe cardiovascular disease;
- •Stroke or acute cardiovascular event within 6 months prior to the planned surgery;
- •Weight loss > 30 kg for any reason within 12 months, or unexplained weight loss > 10 kg within 12 months;
- •Eating disorder or body dysmorphic disorder;
- •Alcohol/drug addiction or mental illness that may affect compliance with postoperative protocols;
- •Pregnant or lactating women;
- •Refusal to sign the informed consent form;
- •Other conditions deemed inappropriate by the investigators.
研究组 & 干预措施
Conventional surgery group
All procedures were performed under general anesthesia, including subacromial decompression, acromioplasty, and rotator cuff repair using a double-row suture bridge technique.
干预措施: Conventional rotator cuff repair. (Procedure)
TSPCs enhanced group
For patients in the TSPCs group, after removing the arthroscopic fluid, TSPCs mixed with fibrin glue were applied to the tendon-bone junction and repaired tendon surface under arthroscopic guidance.
干预措施: Stem cell therapy (Biological)
TSPCs enhanced group
For patients in the TSPCs group, after removing the arthroscopic fluid, TSPCs mixed with fibrin glue were applied to the tendon-bone junction and repaired tendon surface under arthroscopic guidance.
干预措施: Conventional rotator cuff repair. (Procedure)
结局指标
主要结局
Phase I：Incidence and severity of cell therapy related adverse events
时间窗: In 12 weeks
Incidence and severity of cell therapy related adverse events:Adverse events are defined as abnormal laboratory test results, symptoms or signs, and are graded using the Common Terminology Criteria for Adverse Events (CTCAE). Serious adverse events are defined as any grade 3 or 4 adverse events as specified in the CTCAE.
Phase II：Oxford Shoulder Score (OSS)
时间窗: 24 weeks
OSS is a patient-reported measure used to assess functional limitations following shoulder surgery. It consists of 12 items, each with five response categories, and scores can range from 0 (indicating the worst functional status) to 48 (indicating the best functional status).
次要结局
- Constant-Murley Score (CMS)(Baseline,Post-op Week 12,Post-op Week 24,Post-op Week 48)
- Shoulder pain at rest(Baseline,Post-op Week 1,Post-op Week 4,Post-op Week 8,Post-op Week 12,Post-op Week 24,Post-op Week 48)
- Work status(Baseline,Post-op Week 12,Post-op Week 24,Post-op Week 48)
- Tendon Integrity Classification on MRI(Post-op Week 24, Post-op Week 48)
- Range of Motion (ROM)(Baseline,Post-op Week 12,Post-op Week 24,Post-op Week 48)
- Muscle wasting of rotator cuff on MRI(Baseline, Post-op Week 24, Post-op Week 48)