EUCTR2016-001262-28-ES进行中（未招募）1 期
Treatment of Refractory Patellar Tendinopathy with MSV *. Comparative study with P-PRP*MSV are bone marrow autologous mesenchymal stem cells, selected and cultured under Good manufacturing Practices of the Insitute of Biology and Molecular Genetics (University of Valladolid and CSIC).
Institut de Terapia Regenerativa Tissular S.L. (ITRT)0 个研究点开始时间: 2017年6月6日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
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
- Male
入选标准
- •1. Males with ages between 18 and 48 years.
- •2. Patellar tendon pain, located in the insertion zone, of more than 4 months duration that does not show significant improvement after conservative treatments such as rest, analgesia, physiotherapy and / or infiltration.
- •3. Echographic image confirming, in both static and dynamic states, the loss of the fibrillar structure of the proximal part of the patellar tendon, thickening of the patellar tendon and a hypoechogenic lesion compatible with a gap =3 mm.
- •4. Patellar tendon MRI scan T2 FAT SAT (fat saturation) showing a gap =3mm in longitudinal diameter at the proximal insertion.
- •5. Informed Consent in writing and signed by the patient.
- •6. The patient is able to understand the nature of the study
- •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) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Patient under 18 years of age (or legally dependent) and over 48 years.
- •2. MRI with grade III-IV intrarticular pathology of all knee compartments and / or cruciate ligament injury
- •3. Local treatment with corticosteroids during the last year
- •4. Local treatment with PRP during the last 6 months.
- •5. Infection (no local or systemic infectious signs should be evident).
- •6. Patients presenting positive serology against: HIV 1 and 2, Hepatitis B (HBsAg, HBcAc), Hepatitis C (Anti-HCV-Ab), Syphilis.
- •7. Congenital or evolutional diseases that cause malformation and / or significant deformation of the knee and condition difficulties of application and evaluation of the results.
- •8. Overweight expressed in body mass index (BMI) greater than 30.5 (obesity grade II). If BMI = mass (Kg): (height (m)) 2
- •9. Active neoplastic disease.
- •10. Active immunodepressive states.
- •11. Simultaneous participation in another clinical trial or treatment with another product in the research phase in the 30 days prior to inclusion in the study.
- •12. Other pathologies or circumstances that compromise participation in the study according to medical criteria
研究者
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