NCT00883870已完成1 期
A Randomized, Double Blind, Multicentric, Placebo Controlled, Single Dose, Phase - i/ii Study Assessing the Safety and Efficacy of Intramuscular ex Vivo Cultured Adult Allogenic Mesenchymal Stem Cells in Patients With Critical Limb Ischemia (Cli)
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 4
- 主要终点
- AE and symptomatic relief
研究概览
简要总结
This clinical trial aims to study the safety and efficacy of adult mesenchymal stem cells in critical limb ischemia.
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
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males or females with non-child bearing potential in the age group of 18-60 yrs of Indian origin.
- •Established CLI, clinically and hemodynamically confirmed as per Rutherford- II-4, III-5, or III-6; Patients having Infra-inguinal arterial occlusive disease with rest pain or ischemic ulcer/necrosis, who are not eligible for or have failed traditional revascularization treatment (No option patients)
- •Ankle Brachial Pressure Index (ABPI) ≤ 0.6 or ankle pressure ≤ 70 mm Hg or TcPO2 ≤ 60 mmHg in the foot
- •Patients if having associated Type II Diabetes, should be on medication and well controlled (HbA1c ≤ 8%) without complications
- •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
- •Normal liver and renal function
- •On regular medication for hypertension if any
排除标准
- •Patients with CLI suitable for surgical or percutaneous revascularization as determined by the surgeon performing vascular procedure and patients with any acute/chronic inflammatory condition
- •CLI patient requiring amputation proximal to trans-metatarsal level
- •Patients with gait disturbance for reasons other than CLI.
- •Type I diabetes
- •Patients having respiratory complications/left ventricular ejection fraction < 25%f) Stroke or myocardial infarction within last 3 months
- •Patients who are contraindicated for MRA
- •Have clinically serious and/or unstable inter-current infection, medical illnesses or conditions that are uncontrolled or whose control, in the opinion of the Investigator, may be jeopardized by participation in this study or by the complications of this therapy
- •Documented terminal illness or cancer or any concomitant disease process with a life expectancy of less than 1 year
- •Patients already enrolled in another investigational drug trial or completed within 3 months.
- •History of severe alcohol or drug abuse within 3 months of screening.
- •Hb% < 10 gm%, Serum Creatinine ≥ 2mg%, Serum Total Bilirubin ≥2mg%, HbA1c > 8%
- •Women with child bearing potential, pregnant and lactating women.
- •Patients tested positive for HIV 1, HCV, HBV,
研究组 & 干预措施
Placebo
Experimental
Intramuscular injection
干预措施: Plasmalyte A (Drug)
mesenchymal stem cells
Experimental
Intramuscular injection
干预措施: mesenchymal stem cells (Drug)
结局指标
主要结局
AE and symptomatic relief
时间窗: 6 months
次要结局
- Increase in transcutaneous partial oxygen pressure (TcPO2) and Ankle brachial pressure index (ABPI) - measured by Doppler(6 months)
研究者
研究点 (4)
Loading locations...
相似试验
已完成
1 期
Ex Vivo Cultured Bone Marrow Derived Allogenic MSCs in AMIMyocardial InfarctionNCT00883727Stempeutics Research Pvt Ltd20
已完成
2 期
Allogeneic Mesenchymal Stem Cells in OsteoarthritisOsteoarthritis of KneeNCT01453738Stempeutics Research Pvt Ltd60
已完成
2 期
Allogeneic Mesenchymal Stem Cells for OsteoarthritisOsteoarthritis of Knee JointNCT01448434Stempeutics Research Pvt Ltd72
Unknown
2 期
Efficacy and Safety Study of Allogenic Mesenchymal Stem Cells for Patients With Chronic Graft Versus Host DiseaseChronic Graft Versus Host DiseaseNCT01526850Chinese Academy of Medical Sciences100
已完成
2 期
Trial of Autologous Mesenchymal Stem Cells in Patients With Multiple System AtrophyMultiple System AtrophyNCT00911365Yonsei University27