EUCTR2010-024664-17-CZ进行中（未招募）1 期
tilization of Autologous Mesenchymal Cells to Enhance Rotator Cuff Repair - a Prospective Non-randomized, Open-Label Study to Assess the Safety and the Efficacy. - AMSC in RC
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. males or females between 40 and 65 years of age,
- •2. written informed consent obtained,
- •3. complete unilateral rotator cuff tear on pre-operative clinical and imaging findings,
- •4. elected to undergo an arthroscopic repair of their rotator cuff tear,
- •5. agreed to wear a dedicated brace for four weeks post-operatively,
- •6. minimum pre-operative haemoglobin of 11.0 g/dl or more,
- •7. pre-operative platelet count greater than 150 000 / 1 mm3.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 20
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 4
排除标准
- •1. a tear involving the subscapularis or biceps tendons,
- •2. a previous rotator cuff repair,
- •3. moderate-to-severe osteoarthritis of the glenohumeral joint,
- •4. loss of passive elevation in any direction when compared to the contralateral shoulder,
- •5. fatty infiltration greater than 50 % of the cross sectional area of supraspinatus or infraspinatus assessed on the most lateral image on which the scapular spine is in contact with the scapular body,
- •6. a massive tear with a contracted immobile cuff confirmed in operation,
- •7. an active infection, osteomyelitis or sepsis or distant infections which may spread to the site of operation,
- •8. other diseases which may have limit follow-up (immunocompromission, hepatitis, active tuberculosis, neoplastic diseases, septic arthritis),
- •9. osteomalacia or other metabolic bone disorders which may impair bone or soft tissue function,
- •10. vascular insufficiency, muscular atrophy or neuromuscular diseases of the affected arm,
- •11. pregnant or lactating women,
- •12. alcohol or drug abusers,
- •13. patients on corticosteroids (7 days before operation), immunosuppressants (3 months before operation) or anticoagulant therapy (7 days before operation),
- •14.women of childbearing potential not using effective contraception (established oral contraception, intrauterine device, ligation of the uterine tube) including proven contraceptive measures taken by their sexual partners,
- •15.fertile men not using proven contraceptive measures including effective contraception of their partner (established oral contraception, intrauterine device, ligation of the uterine tube).
研究者
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