jRCT2052230115招募中不适用
An exploratory study of angiogenic therapy by autologous peripheral blood mononuclear cell-bearing ICS-001 transplantation in patients with chronic limb-threatening ischemia (CLTI) with refractory ulcers or ischemic resting pain
未提供0 个研究点目标入组 6 人开始时间: 2024年6月20日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 6
- 主要终点
- Incidence of adverse events
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Single Arm Study
- 干预模型
- Single Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- 20age old over 至 85age old under（—）
- 性别
- All
入选标准
- •Patients who meet all of the following criteria are eligible:
- •(1) Patients with arteriosclerosis obliterans (ASO) or Buerger's disease
- •(2) Patients with confirmed occlusion or stenosis by angiography, MRA, or CTA of the lower extremities within 6 months prior to subject enrollment
- •(3) Patients with Ischemia grade 2 or higher in WIfI classification
- •(4) Patients with refractory ulcers of Wound grade 1 in WIfI classification or Wound grade 0 with ischemic rest pain, that are not suitable for revascularization (endovascular treatment or bypass surgery) or that do not heal for more than 4 weeks despite revascularization.
- •(5) Non-smoker or patients who have stopped smoking for at least 1 month, and are able to quit smoking throughout the study period (only for Buerger's disease patients)
- •(6) Patients who are more than 20 years old and less than 85 years old at the time of consent, and whose written consent has been obtained
排除标准
- •Patients who meet any of the following criteria should be excluded:
- •(1) Patients scheduled for major amputation
- •(2) Patients with Wound grade 2 or higher in WIfI classification
- •(3) Patients with Ischema grade 1 or lower in WIfI classification
- •(4) Patients with Foot infection grade 2 or higher in WIfI classification
- •(5) Patients who underwent revascularization, sympathectomy/sympathetic ganglion block, cell therapy/gene therapy, or minor amputation for the purpose of CLTI treatment in the lower extremities to which ICS-001 will be implanted within 4 weeks prior to obtaining consent
- •(6) Patients with poorly controlled ischemic heart disease or heart failure
- •(7) Patients with poorly controlled diabetes mellitus
- •(8) Patients with severe hepatic dysfunction
- •(9) Patients with severe chronic kidney disease (eGFR under 30 mL/min/1.73 m2) (not applicable to hemodialysis patients)
- •(10) Patients undergoing peritoneal dialysis or post renal transplantation
- •(11) Patients with a history of serious hypersensitivity or adverse reactions to Filgrastim (Gran), Plerixafol (Mozobil), or Apheresis
- •(12) Patients on chronic maintenance hemodialysis with concomitant or pre-existing interstitial pneumonia
- •(13) Patients with leukemia, myeloproliferative disorders, or myelodysplastic syndrome
- •(14) Patients who have undergone percutaneous coronary intervention within 2 months prior to obtaining consent
- •(15) Patients complicated with malignant tumors
- •(16) Patients with untreated proliferative diabetic retinopathy (modified Davis classification: proliferative retinopathy)
- •(17) Patients with infectious diseases associated with a fever of 38 degrees or higher
- •(18) Patients with severe hypoalbuminemia (albumin level less than 2.0 g/dL)
- •(19) Patients with low BMI (under 18)
- •(20) Patients with claudication, pain at rest, skin ulcer, or gangrene due to other factors not caused by the primary disease
- •(21) Patients with psychiatric disorders that are difficult to control
- •(22) Patients with clinically problematic splenomegaly
- •(23) Patients who are participating in other clinical trials or who have not completed a previous clinical trial more than 3 months after the completion of the previous trial
- •(24) Pregnant women, lactating women, female patients who may be pregnant or planning to become pregnant by the end of the study period, or male patients whose partners wish to become pregnant
- •(25) Patients who are unlikely to survive beyond 12 months after the date of consent
- •(26) Other patients who are judged by the investigator or subinvestigator to be inappropriate as subjects for this clinical trial.
结局指标
主要结局
Incidence of adverse events
Incidence of adverse events determined to be causally related to protocol treatments defined in this study protocol (Filgrastim (Gran), Plerixafor (Mozovir), apheresis, anesthesia, ICS-001-autologous peripheral blood mononuclear cell-transplantation procedure, peripheral blood mononuclear cells, ICS-001)
次要结局
- WIfI classification (Wound, Ischemia, Foot Infection) grade and Clinical stage
- Rutherford classification
- Percentage reduction in area of target ulcer
- Number of new ulcers that appeared during the observation period
- Ankle brachial index (ABI)
- Toe brachial pressure index (TBI)
- Skin perfusion pressure (SPP)
- Transcutaneous partial oxygen pressure (TcPO2)
- Absolute claudication distance (ACD)
- Initial claudication distance (ICD)
- Numerical Rating Scale (NRS)
- Analgesic Quantification Algorithm (AQA)
- Lower limb major amputation avoidance rate
- Avoidance rate of lower limb amputation (major and unplanned minor amputation)
- Overall survival
- Adverse events other than primary endpoint
- Vital signs
- Laboratory values
- Adverse events of ICS-001
研究者
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