EUCTR2011-003934-16-DE进行中（未招募）不适用
A Phase I/II, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Efficacy of Intramuscular Injections of Allogeneic PLX-PAD Cells for the Regeneration of Injured Gluteal Musculature after Total Hip Arthroplasty - PLX-PAD 1301-01
Pluristem Ltd.0 个研究点目标入组 18 人开始时间: 2012年2月14日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 18
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. Adult male or female subjects between 50 to 75 years of age at the time of screening visit.
- •2. Scheduled THA
- •3. ASA Score = 3
- •4. Signed written informed consent.
- •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 6
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 12
排除标准
- •1. Muscle diseases
- •2. Sever neurological diseases
- •3. Opioid long term medication
- •4. Pain chronification > stadium II of Gerbershagen
- •5. Immunosuppression due to illness or medication
- •6. Ankylosing spondylitis
- •7. History ofectopic bone formation of any localisation
- •8. Exclusion criteria for MRI (pace maker, defibrillator, ferromagnetic intracerebral clips)
- •9. Uncontrolled hypertension (defined as diastolic blood pressure > 100 mmHg or systolic blood pressure > 200 mmHg during screening)
- •10. Life-threatening ventricular arrhythmia or unstable angina - characterized by increasingly frequent episodes with modest exertion or at rest, worsening severity, and prolonged
- •11. ST segment elevation myocardial infarction and/or TIA/CVA within three (3) months prior to enrollment. Subjects with severe congestive heart failure symptoms (i.e. NYHA Stage IV)
- •12. Subject has malignancy undergoing treatment including chemotherapy, radiotherapy or immunotherapy
- •13. Body Mass Index (BMI) of 35 Kg/m2 or greater.
- •14. Known allergies to protein products (horse or bovine serum, or porcine trypsin) used in the cell production process
- •15. Known HIV, syphilis at time of screening
- •16. Known active Hepatitis B, or Hepatitis C infection at the time of screening
- •17. Pregnant or breast-feeding women or women of childbearing potential not protected by an effective contraceptive method of birth control (defined as pearl index < 1)
- •18. In the opinion of the investigator, the subject is unsuitable for cellular therapy
- •19. Subject is currently enrolled in, or has not yet completed a period of at least 30 days since ending other investigational device or drug trial(s)
- •20. Subjects who are legally detained in an official institute
研究者
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