Effects and Benefits of Repeated Injections of Adipose-derived Stem Cells on Shoulder Function in Rotator Cuff Tears: A Randomized Controlled Study
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 30
- 主要终点
- Change in the Oxford Shoulder Score (OSS)
研究概览
简要总结
The aim of the project is to investigate whether repeated implantations of micro-fragmented adipose tissue (MFAT), into the shoulder muscle can improve the outcome of standard surgical treatment for rotator cuff tears (RCT). The investigators hypothesize that combining surgery with repeated implantations of micro-fragmented adipose tissue (MFAT) into the muscle provides a more effective treatment for patients with rotator cuff tears compared to standard surgical treatment. The result would be better outcomes such as improved shoulder functioning and reduced pain.
详细描述
Treatment of RCTs with micro-fragmented adipose tissue is a minimal invasive procedure with the potential to shorten recovery, accelerate return to daily activity and work and improve functional outcomes compared to conventional surgery alone.
This study will provide evidence on whether three MFAT injections can augment conventional rotator cuff tear treatment. It will also assess the feasibility of implementing this treatment as part of standard care, given its potential for easy standardization. In addition to offering a novel therapeutic approach, the project will correlate functional outcomes with data from muscle biopsies, phenotypic composition of the implanted cells, imaging modalities, and patient reported outcomes. This study will generate critical new knowledge and serve as a cornerstone for the development of precision regenerative medicine in shoulder pathology. By elucidating patient-specific biological responses and therapeutic outcomes, the investigators aim to advance personalized treatment strategies for rotator cuff tears. Building on these findings, we aim to launch a clinical trial to further validate precision medicine as a standard therapeutic approach for patients suffering from rotator cuff tears.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 69 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical signs and symptoms compatible with a traumatic RCT
- •MR verified supraspinatus tear
- •Reparable lesion with tendon retraction < 2 cm.
- •Fatty infiltration level 0-2 according to Fuchs or out of 5 based on Goutalliers classification
- •No history of inflammatory disease
- •Negative infectious disease marker tests Signed consent to the study
排除标准
- •Former surgery in the affected shoulder
- •Signs of infection
- •Immunosuppression (due to clinical condition or medical therapy)
- •Any malignancy within 5 years prior to screening
- •Previous radiotherapy to the shoulder
- •BMI under 18
- •BMI above 35
- •Allergy to antibiotics such as penicillin
- •Coagulopathy
研究组 & 干预措施
Triple injection
During the surgery a total of 5 mL of the stem cell suspension is injected into the supraspinatus muscle at three predefined sites located at the musculotendinous junction. For each site, 1.5-2.0 mL of the suspension is administered using an 18-gauge syringe. The stem cell treatment will be repeated at week 4 og 8 post operatively in an outpatient clinic. The injection will be performed under sterile conditions, local anesthesia, and guided by ultrasound to locate the musculotendinous junction of the supraspinatus muscle.
Adipose derived stem cell injections for the triple injection will be repeated at 4 and 8 weeks postoperatively. These follow-up treatments will be performed in an outpatient clinic.
干预措施: Adipose derived stem cell injection (Biological)
结局指标
主要结局
Change in the Oxford Shoulder Score (OSS)
时间窗: Baseline and 12 months
The Oxford Shoulder Score (OSS) is a 12-item, patient-reported questionnaire designed to measure pain and functional impairment in patients with shoulder pain. It assesses symptoms over the past four weeks, with a modified scoring method (0-4 per question) totaling 0-48 (48 being the best, 0, worst).
次要结局
- Change in the Oxford Shoulder Score (OSS) at 3 months(Baseline and 3 months)
- Change in the Oxford Shoulder Score (OSS) at 6 months(Baseline and 6 months)
- Change in Quality of Life at 3 months(Baseline and 3 months)
- Change in Quality of Life at 6 months(Baseline and 6 months)
- Change in Quality of Life at 12 months(Baseline and 12 months)
- Change in Radiological healing at 3 months(Baseline and 3 months)
- Change in Radiological healing at 6 months(Baseline and 6 months)
- Change in Radiological healing at 12 months(Baseline and 12 months)
- Change in infiltration with Goutallier at 6 months(Baseline and 6 months)
- Change in infiltration with Goutallier at 12 months(Baseline and 12 months)