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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
107
For patients in the TSPCs group, after removing the arthroscopic fluid, the prepared TSPCs loaded on a scaffold were injected into the tendon - bone junction and over the repaired tendon using a spinal needle. Fibrin glue (Fibrin Sealant (Human), RAAS) served as the scaffold. The TSPCs suspension was first mixed with thrombin solution at a 3:1 ratio. Then, using the DUPLOJECT syringe support system (Fibrin Sealant (Human), RAAS), 2 ml of cell - thrombin suspension was combined with 2 ml of fibrinogen solution at a 1:1 ratio and applied to the repaired tendon surface. After extracting the arthroscopic fluid, this cell - thrombin - fibrinogen suspension was implanted under arthroscopic guidance. A probe was used to spread and adjust the fibrin glue to cover the repaired tendon - bone junction and tendon surface.
All procedures were performed under general anesthesia. Patients were in a beach-chair position. After glenohumeral inspection, subacromial decompression was conducted, and acromioplasty was performed. After subacromial decompression, the upper surface of the greater tuberosity was abraded to create a bleeding cancellous bone bed. The footprint of the greater tuberosity was debrided. Rotator cuff repair was performed using a double-row suture bridge technique. For medial-row repair, a hole was punched in the greater tuberosity, and a bioabsorbable suture anchor was inserted. After the medial row was completed, the suture limbs were used to create suture bridges over the tendon. The lateral fixation points were placed, and the suture anchor was used for lateral-row fixation.
Phase I：Incidence and severity of cell therapy related adverse events
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.
Time frame: In 12 weeks
Phase II：Oxford Shoulder Score (OSS)
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).
Time frame: 24 weeks
Constant-Murley Score (CMS)
The CMS provides an assessment of both Individual parameters and clinical symptoms, which is sufficiently sensitive to reveal even small changes in function. The score consists of four domains : pain (15 points), activities of daily living (20 points), movement (40 points), and strength (25 points).
Time frame: Baseline,Post-op Week 12,Post-op Week 24,Post-op Week 48
Range of Motion (ROM)
The examiner passively moved the patient's upper extremity to the end range of flexion, abduction, internal rotation, and external rotation, ensuring movements were within the patient's comfort level. Internal and external rotation were measured at 90° of abduction.
Time frame: Baseline,Post-op Week 12,Post-op Week 24,Post-op Week 48
Shoulder pain at rest
A Numerical Rating Scale from 0 to 10 with "0" representing no pain and "10" representing the worst pain imaginable in the preceding week.
Time frame: 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
Normal duties, restricted duties/hours, not working.
Time frame: Baseline,Post-op Week 12,Post-op Week 24,Post-op Week 48
Tendon Integrity Classification on MRI
According to SUGAYA Classification.
Time frame: Post-op Week 24, Post-op Week 48
Muscle wasting of rotator cuff on MRI
Measured using Goutallier classification (Stages 0-4).
Time frame: Baseline, Post-op Week 24, Post-op Week 48
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