An Open Labeled, Single-center, Phase I Study Assessing the Safety and Efficacy of Autologous Bone Marrow Derived Mesenchymal Stem Cells in Critical Limb Ischemia
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 主要终点
- Ankle Brachial Pressure Index, ABPI
研究概览
简要总结
This clinical trial to study the Safety and Efficacy of Autologous Mesenchymal stem cells in critical limb ischemia.
详细描述
If the participant voluntarily agrees to participate in the clinical trial before registration, the investigator conducts a screening test to evaluate the participant's suitability.
A participant that satisfies all inclusion and exclusion criteria is assigned a test group(2-time injection group).
Participants conduct cell therapy within 30 days after bone marrow aspiration, and will re-inject autologous mesenchymal stem cells within 30 days after first injection.
Participants will make a total of 5 hospital visits after registration, and Safety and Efficacy will be evaluated based on a fixed procedure on every visit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age from 20 to 80 years
- •Patients with resting pain or ulceration of limb (Rutherford's class: II-4, III-5 or III-6)
- •Ankle Brachial Pressure Index (ABPI) ≤ 0.6 or TCPO2 ≤ 60mmHg in the foot
- •Patients who were unsuitability for percutaneous transluminal angioplasty or a bypass operation
- •Patients who are not expected other treatments for at least 6 months
- •Patients who can agree to participate in the clinical trial by oneself or by one's legal representative
- •Patients who can conduct the clinical trial according to the protocol
排除标准
- •Buerger's disease
- •History of hematologic disease
- •Patients who are at risk of embolism due to atrial fibrillation
- •Primary hematologic disease, including hypercoagulable states
- •Entrapment syndrome
- •Patients with osteomyelitis
- •Patients whose blood serum AST(Aspartate transaminase)/ALT(Alanine Transaminase) rates are more than three times the normal maximum rate, or whose creatinine rates are more than 1.5 times the normal maximum rate
- •Patients with history of anaphylaxis to gentamicin
- •Patients with hypersensitivity of bovine-derived ingredients
- •Patients with chronic heart failure, Glomerular disease and Obstructive pulmonary disease
- •Patients with Stroke or transient ischemic attack within 6 months prior to registration
- •Patients tested positive for HIV(Human Immunodeficiency Virus), HCV(Hepatitis C Virus), HBV(Hepatitis B Virus) and Syphilis
- •Patients with history of aorta and artery bypass operation, or angioplasty within 2 months recently
- •Patients in need of a immediate amputation and have a potentially life-threatening complications of critical ischemia
- •Patients with history of cell therapy
- •Type I diabetes
- •Uncontrolled diabetes mellitus (HgbA1C>8%)
- •Uncontrolled hypertension
- •Has a medical record of solid cancer, or diagnosed with solid cancer and currently receiving cancer treatment
- •Positive of tumor markers test(AFP((Alpha fetoprotein), CEA(Carcinoembryonic antigen), CA15-3(Cancer antigen 15-3 for breast cancer) and PSA(Prostate-specific antigen), or have received a diagnosis of cancer based on National cancer screening program
- •Pregnancy, possible candidate for pregnancy or lactating women
- •Infectious disease
- •Administrating of immunosuppressive agents, corticosteroid formulation and cell toxicity formulation, or requiring administration of the test period
- •Patients already enrolled in another clinical trials or completed within 3 months
- •Patients who cannot adapt to the protocol and follow-up observation
- •Patients who has experienced drug abuse for the past 1 year
- •Patients with any disease or condition which the investigator fell would interfere with trial or the safety of the subject
研究组 & 干预措施
2-time injection group : Cellgram-CLI
Within 30 days after extracting bone marrow, autologous bone marrow-derived mesenchymal stem cells is directly injected into the lesion. Then the second cell is injected within 30 days after the first cell injection.
干预措施: Cellgram-CLI (Drug)
结局指标
主要结局
Ankle Brachial Pressure Index, ABPI
时间窗: 6 months after BM-MSC therapy
Use Student's paired t-test or Wilcoxon's signed rank test to compare the difference of between the two visits(Screening and 6 month post treatment) before and after treatment.
次要结局
- Collateral vessel formation on digital subtraction angiography (DSA)(6 months after BM-MSC therapy)
- Difference of Wound size(6 months after BM-MSC therapy)
- Improved transcutaneous oxygen pressure (TCPO2)(6 months after BM-MSC therapy)
- Pain on the Visual Analogue Scale(VAS)(6 months after BM-MSC therapy)
- Reduced limb amputation(6 months after BM-MSC therapy)
- Temperature change on thermography(6 months after BM-MSC therapy)
- Dose about using analgesic medicine(6 months after BM-MSC therapy)
- Change in Rutherford classification(6 months after BM-MSC therapy)
- Frequency about using analgesic medicine(6 months after BM-MSC therapy)