NCT03239535Unknown1 期
Allogeneic Mesenchymal Stem Cells for the Critical Limb Ischemia Therapy
Federal Research Clinical Center of Federal Medical & Biological Agency, Russia1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2013年10月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Adverse events
研究概览
简要总结
The clinical trial aims to study the safety and efficacy of adult allogeneic mesenchymal stem cells for the treatment of critical limb ischemia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males or females in the age group of 18-80 yrs of Caucasian origin.
- •Peripheral artery disease (PAD) against the background of atherosclerosis and diabetes mellitus (DM)
- •Critical lower limb ischemia (stages 3-4 by Fontaine-Pokrovsky or stages 4-6 by Rutherford)
- •Patients with remaining symptoms of critical limb ischemia (CLI) in spite of the performed surgical (endovascular or open) treatment and continuing conservative therapy
- •Patients with absent emergency indications to major amputation
- •Patients planned for the reconstructive surgery with a questionable remote outcome due to compromised blood outflow
- •Ankle Brachial Pressure Index (ABPI) ≤ 0.5 or ankle pressure ≤ 70 mm Hg
- •Patients, if having associated Type II Diabetes, should be on medication and well controlled (HbA1c ≤ 8.5 %)
- •On regular medication for hypertension if needed
- •Normal liver and renal function (or having clinically insignificant deviations, according to the treating physician's opinion)
- •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
排除标准
- •Humid gangrene or acute/chronic infection of lower limb.
- •Dry gangrene with extensive foot lesion (> 1\2).
- •Acute arterial failure.
- •Life-threatening conditions and predicted life expectancy of < 6 months.
- •Presence of neoplasm or bone marrow disease
- •Signs of active or chronic, including latent, haemorrhage
- •Any acute or chronic infectious disease
- •Renal failure determined as twofold or higher elevation of serum creatinine as compared to the upper normal limit
- •Hepatic failure determined as the bilirubin, alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels elevated by two and more times over the upper normal limits
- •Thrombocytopenia (platelet counts < 50,000 /µl), leukocytopenia (WBC < 4,000/µl), immunosuppressive therapy
- •Pronounced neurological deficit
- •Patients with gait disturbance for reasons other than CLI
- •Patients not suitable for cell therapy, by the treating physician's opinion
- •CLI patients requiring amputation at the proximal to the trans-metatarsal level
- •Patients with Type I diabetes
- •Patients having respiratory complications/left ventricular ejection fraction < 25%
- •Stroke or myocardial infarction within last 3 months
- •Patients who are contraindicated for X-ray angiography
- •History of severe alcohol or drug abuse within 3 months of screening
- •Pregnant and lactating women.
- •Patients tested positive for HIV 1, hepatitis C virus (HCV), hepatitis B virus (HBV)
- •Unsigned informed consent
研究组 & 干预措施
Mesenchymal stem cells
Experimental
Mesenchymal stem cells, Intramuscular injection
干预措施: Mesenchymal stem cells (Biological)
Normal saline
Placebo Comparator
Normal saline, Intramuscular injection
干预措施: Normal saline (Biological)
结局指标
主要结局
Adverse events
时间窗: 24 months
Number of adverse events reported
Amputation-free survival
时间窗: 24 months
Number of survived patients
次要结局
- Limb salvage from major amputation(3, 6, 12, 24 months)
- Improvement in perfusion by the ankle-brachial index(Immediate, 3, 6, 12, 24 months)
- Improvement in healing trophic disorders(Immediate, 3, 6, 12, 24 months)
- Improvement in total walking distance (TWD) using a standard treadmill test(Immediate, 3, 6, 12, 24 months)
- Relief of the rest pain(Immediate, 3, 6, 12, 24 months)
- Improvement in perfusion by radioisotope scintigraphy(Immediate, 3, 6, 12, 24 months)
研究者
研究点 (1)
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