A Randomized, Double Blind, Placebo Controlled Trial, Investigating the Effect of Intramuscular Injection of Allogenic Platelet Lysate for the Treatment of PAD
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
研究概览
简要总结
Allogenic platelet lysate will be injected in the gastrocnemius of patients with peripheral arterial disease (PAD)
详细描述
Allogenic platelet rich plasma (PRP) will be collected from blood group AB donors. This plasma will be tested for the presence of any chronic infectious blood borne disease.
Platelet lysate will be then prepared from the tested PRP to be intramuscularly injected in patients with PAD
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, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Competent and willing to give informed consent, and to be available for all baseline treatment and follow up examinations required by the protocol.
- •Gender: Male or female.
- •Age group > 50 years.
- •Established Critical limb ischemia (CLI), clinically and hemodynamically confirmed as per Rutherford 3, 4 and 5 with angiographic evidence of significant infra-inguinal arterial occlusive disease.
- •History of intermittent claudication for > eight weeks.
- •Limited exercise due to moderate to severe claudication.
- •Resting ABI < 0.6, toe pressure ≤ 60 mm Hg, Toe Brachial index (TBI) <0.6, or TcPO2 ≤ 60 mmHg in the foot.
- •Not eligible for surgical or radiological revascularization, and doesn't respond to best standard care delivered as confirmed by a vascular surgeon and/or physician.
- •Fairly controlled diabetes (Hemoglobin A1c <10%).
- •Normal liver enzymes, serum creatinine < 1.4
- •Normal platelet count.
- •On regular medication for hypertension if any.
- •No evidence of malignancy
- •Body mass index <30.
排除标准
- •Women with child bearing potential, pregnant and lactating women.
- •Rheumatoid Arthritis.
- •History of neoplasm or malignancy in the past 10 years.
- •Reported unstable cardiovascular disease, heart failure or symptomatic postural hypotension within 6 months before screening.
- •Leg edema
- •Inflammatory or progressive fibrotic disorder
- •Renal insufficiency or failure
- •History of infectious disorder (Human immunodeficiency virus (HIV) and/or hepatitis viruses).
- •Chronic inflammatory disease
- •History of stroke or myocardial infarction (< 3 months).
- •Bleeding or clotting disorder, use of oral anticoagulant therapy (heparin, warfarin).
研究组 & 干预措施
Platelet lysate
A total of 5 ml platelet lysate will be intramuscularly injected in 4 doses with 2 week interval
干预措施: Platelet lysate (Biological)
placebo
A total of 5 ml of Normal Saline will be intramuscularly injected in 4 doses with 2 week interval
干预措施: Placebo (Biological)
结局指标
主要结局
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
时间窗: 6 months
Frequency and nature of adverse events occurring during a 6-month period following platelet lysate injection(s). This will be assessed by physical examination combined with a report with chemistry blood tests.
次要结局
- Evaluation of the preliminary efficacy of the platelet lysate injection on patients' ABI(12 months)
- Evaluation of the preliminary efficacy of the platelet lysate injection on patients' Toe pressure(12 months)
- Evaluation of the preliminary efficacy of the platelet lysate injection on patients' TcPO2(12 months)
研究者
Sophia Al-Adwan
Clinical Co-ordinator
University of Jordan