Clinical Study on the Safety and Efficacy of Tendon Stem Progenitor Cells Therapy for Rotator Cuff Tears

Обзор

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.

Вмешательства

• Биопрепарат Stem cell therapy
  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 fibri
• Процедура Conventional rotator cuff repair.
  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 p

Первичные конечные точки

• Phase I：Incidence and severity of cell therapy related adverse events [Срок оценки: In 12 weeks]
• Phase II：Oxford Shoulder Score (OSS) [Срок оценки: 24 weeks]

Вторичные конечные точки (6)

• Constant-Murley Score (CMS) [Срок оценки: Baseline,Post-op Week 12,Post-op Week 24,Post-op Week 48]
• Range of Motion (ROM) [Срок оценки: Baseline,Post-op Week 12,Post-op Week 24,Post-op Week 48]
• Shoulder pain at rest [Срок оценки: 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 [Срок оценки: Baseline,Post-op Week 12,Post-op Week 24,Post-op Week 48]
• Tendon Integrity Classification on MRI [Срок оценки: Post-op Week 24, Post-op Week 48]
• Muscle wasting of rotator cuff on MRI [Срок оценки: Baseline, Post-op Week 24, Post-op Week 48]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07320378 · 2025-1814

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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