EUCTR2010-024391-25-CZ进行中（未招募）不适用
A Multi-centre, double blind, randomized placebo controlled phase II study to assess the efficacy and safety of ASCT01 in Critical limb Ischemia Patients - SCILI - SCILI
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 88
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.Patients in the age group of 18-75 yrs.
- •2.Established CLI (confirmed by Rutherford 4 to 6 or Fontaine III-IV to the
- •recommendations of the TASC) with infra-inguinal arterial occlusive
- •3.Ankle Brachial Pressure Index (ABPI) = 0.6 or the absolute ankle blood
- •pressure < 60 mm Hg or TcPO2 <20 mmHg without tissue loss or TcPO2
- •<40 mmHg if there is tissue loss.
- •4.No surgical or interventional option for revascularization and no response
- •to best standard care delivered as confirmed by a vascular surgeon.
- •5.No immediate life-threatening complication from CLI which would demand
- •immediate amputation.
- •6.Patients who are able to understand the requirements of the study, and
- •willing to provide voluntary written informed consent, abide by the study
- •requirements, and agree to return for required follow-up visits.
- •7.Coagulation status aPTT within normal limits
- •8.Sufficient number of stem cells isolated from bone marrow (> 2 million
- •9.Viability of isolated stem cells > 90%.
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.Acute life threatening complication of limb ischemia with the need for
- •immediate limb amputation to avoid death or clinical deterioration
- •2.Patients with documented terminal illness or cancer or any concomitant
- •disease process with a life expectancy of less than 6 months.
- •3.Patients with a history of severe alcohol or drug abuse within 3 months of
- •4.Known bone marrow diseases which preclude transplantation.
- •5.End-stage renal failure on regular dialysis treatment
- •6.Patients already enrolled in another investigational drug trial or completed
- •within 3 months.
- •7.Pregnancy.
- •8.Patients tested positive for HIV 1, HCV, and/or HBV
研究者
相似试验
进行中（未招募）
不适用
A multi-center randomized, double-blind, placebo controlled, parallel-group study of CD 07743 for the improvement of Lateral Canthal Lines (crow’s feet)Moderate to severe Lateral Canthal LinesMedDRA version: 12.1Level: LLTClassification code 10052609Term: Glabellar frown linesEUCTR2010-021936-33-GBGalderma R&D SNC324
进行中（未招募）
不适用
A multi-center randomized, double-blind, placebo controlled, parallel-group study of CD 07743 for the improvement of Lateral Canthal Lines (crow’s feet)EUCTR2010-021936-33-DEGalderma R&D SNC324
进行中（未招募）
不适用
A multi-center, randomized, double-blind placebo controlled study to evaluate the efficacy and safety of 24 weeks treatment with vildagliptin 50 mg bid as add-on therapy to metformin plus glimepiride in patients with type 2 diabetesEUCTR2010-021097-11-HUovartis Pharma Services AG290
进行中（未招募）
不适用
A multi-center, randomized, double-blind placebo controlled study to evaluate the efficacy and safety of 24 weeks treatment with vildagliptin 50 mg bid as add-on therapy to metformin plus glimepiride in patients with type 2 diabetesEUCTR2010-021097-11-DEovartis Pharma Services AG290
进行中（未招募）
不适用
A multi-center, randomized, double-blind placebo controlled study to evaluate the efficacy and safety of 24 weeks treatment with vildagliptin 50 mg bid as add-on therapy to metformin plus glimepiride in patients with type 2 diabetesType II Diabetes MellitusEUCTR2010-021097-11-GBovartis Pharma Services AG290