Treatment of Rotator Cuff Tears Using Autologous Bone Marrow Mensenchymal Stem Cell Transplantation.
试验速览
- 阶段
- 2 期
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Constant Shoulder Score
研究概览
简要总结
Surgical reconstructive procedures for rotator cuff tears present a number of limitations. The few studies in which the repair integrity is evaluated, have shown the existence of a high rate of reruptures in spite of the fact that the functional results obtained short-term are satisfactory. Morphologic analysis from the sutures, after different follow-up periods, has not shown satisfactory results.
Thus, the purpose of the current study was to test the hypotheses that mesenchymal stem cells (MSCs) included in a membrane into rotator cuff tears improves, the radiograms and the function compared to cell-free tendon defect treatment.
详细描述
The investigators will include: Patients with massive tears from the supraspinatus tendon, in which reconstructive surgery is indicated. Patients will be randomly stratified into two groups.
The first group will receive autologous MSCs transplantation included in a collagen type I membrane (OrthADAPT) and the second group will serve as cell-free controls.
The surgical procedure will be performed by arthroscopic and/or combined technique: arthroscopic subacromial decompression and mini-open rotator cuff repair. The OrthADAPT-cells composite will be put on the sutured area. The radiograms and function will be assessed by independently observers, who will no have knowledge of the study group from which they will have been obtained.
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, Investigator)
入排标准
- 年龄范围
- 55 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject providing informed consent.
- •Comprised subject male/female aged 55-
- •Subject has a supraspinatus tendon rupture.
- •Subject has an unilateral injury.
- •Rupture is enough to need medical assistance.
- •Subject has an conventional medical treatment fail at least 3 months.
- •Subject has a "reparable" injury according to Goutallier´s criteria.
排除标准
- •Subject has a prior clinical history of arthritis, diabetes or inflammatory disease.
结局指标
主要结局
Constant Shoulder Score
时间窗: up to 1 year
次要结局
- Nuclear Magnetic Resonance (RMN)(6 months, one year)
研究者
Benjamin Fernandez Gutierrez
Rheumatologist
Hospital San Carlos, Madrid