NCT01484574已完成2 期
A Non-randomized, Open Label, Multicentric, Dose Ranging , Phase II Study Assessing the Efficacy and Safety of Intramuscular Administration of Stempeucel - CLI™ (ex Vivo Cultured Adult Bone Marrow Derived Allogeneic Mesenchymal Stem Cells) in Patients With Critical Limb Ischemia Due to Buerger's Disease
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 10
- 主要终点
- Healing of ulcerations or reduction of ulcer area in the target limb
研究概览
简要总结
This is an open label, non-randomized, dose ranging study to evaluate the safety and efficacy of different doses of Stempeucel in critical limb ischemia patients.
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
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Buerger's disease as diagnosed by Shionoya criteria
- •Males or females (willing to use accepted methods of contraception during the course of the study) in the age group of 18-65 yrs
- •Established CLI in the study limb, clinically and hemodynamically confirmed as per Rutherford- III-5
- •Patients in Rutherford- III-6 if gangrene extending maximally up to the head of metatarsal but limited to toes (Patients with wet gangrene must undergo wound debridement / amputation before screening)
- •Patients having infrapopliteal occlusive disease with rest pain and ischemic ulcer/necrosis, who are not eligible for or have failed traditional revascularization treatment as per the investigators judgment (No option patients)
- •Ankle Brachial Pressure Index (ABPI) ≤ 0.6 or ankle pressure ≤ 50 mm Hg or TcPO2 ≤ 40 mmHg in the foot of the study limb
- •Patients who are able to understand the requirements of the study, and willing to provide voluntary written informed consent and video consent, abide by the study requirements, and agree to return for required follow-up visits
排除标准
- •Patients with CLI indicated for major amputation during screening
- •Atherosclerotic PAD
- •Ulcers with exposure of tendon and/bone in the shin region
- •Previous above transmetatarsal amputation in study limb
- •Any Lumbar sympathectomy procedure performed less than 90 days prior to the screening
- •Patients with gait disturbance for reasons other than CLI
- •Diagnosis of diabetes mellitus (type 1 or type 2)
- •Patients having left ventricular ejection fraction < 35%
- •Patients suffering from clinically relevant peripheral neuropathy
- •History of Stroke or myocardial infarction
- •Patients who are contraindicated for MRA
- •Patients with deep vein thrombosis in any limb
- •Patients who 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 <1 year
- •Patients already enrolled in another investigational drug trial or completed within 3 months or those who have participated in any stem cell clinical trial
- •Patient with known hypersensitivity to the constituents of the IMP - dimethyl sulfoxide (DMSO) or human serum albumin (HSA)
- •History of severe alcohol or drug abuse within 3 months of screening
- •Hb% < 10 gm% for males, Hb% < 9 gm% for females, serum creatinine ≥ 2mg%, serum Total Bilirubin ≥2mg%
- •Pregnant and lactating women
- •Patients tested positive for HIV 1, HCV, HBV, CMV, RPR
研究组 & 干预措施
Control arm
No Intervention
Standard protocol of care alone
Intermediate dose
Experimental
Stempeucel - CLI will be administered at intermediate dose
干预措施: Allogeneic Mesenchymal Stem Cells (Biological)
Low dose
Experimental
Stempeucel - CLI will be administered at the lowest dose
干预措施: Allogeneic Mesenchymal Stem Cells (Biological)
结局指标
主要结局
Healing of ulcerations or reduction of ulcer area in the target limb
时间窗: 24 months
Complete ulcer healing defined as complete epithelisation of ulcer and partial ulcer healing as at least 30% decrease in ulcer size.
Relief of the rest pain
时间窗: 24 months
Rest pain will be measured using rest pain scale (0 to 10)
Relief of the rest pain
时间窗: 6 months
Rest pain will be measured using rest pain scale (0 to10)
Healing of ulcerations or reduction of ulcer area in the target limb
时间窗: 6 months
Complete ulcer healing defined as complete epithelisation of ulcer and partial ulcer healing as at least 30% decrease in ulcer size.
次要结局
- Major amputation free survival(6 and 24 months)
- Pain free walking distance(6 and 24 months)
- Assessment of electrocardiogram (ECG) parameters(6 and 24 months)
- Ankle brachial pressure index (ABPI) - measured by Doppler(6 and 24 months)
- Increase in transcutaneous partial oxygen pressure (TcPO2)(6 and 24 months)
- Quality of life by King's College VascuQOL questionnaire(6 and 24 months)
- Angiogenesis - collateral blood vessels by Magnetic resonance angiogram (MRA)(6 and 24 months)
- The type of adverse events AE(s), number of AE(s) and proportion of patients with AE(s).(6 and 24 months)
- Assessment of clinical laboratory parameters(6 and 24 months)
- Physical examination findings and assessment of vital signs(6 and 24 months)
研究者
研究点 (10)
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