(Intraarterial Progenitor Cell Transplantation of Bone Marrow Mononuclear Cells for Induction of Neovascularization in Patients With Peripheral Arterial Occlusive Disease)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Ankle brachial index
研究概览
简要总结
Patients with peripheral artery disease, stage III or IV who are not candidates for interventional or operative therapy should be treated with intraarterial progenitor cell therapy (autologous bone marrow cells) in a randomized, placebo controlled trial.
详细描述
Main goal:
Improvement of limb perfusion (Ankle brachial index).
Secondary aims:
Reduction of pain Reduction of Ulcer size Walking distance Improvement in tissue oxygenation (TCO2) Minor or major amputation
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
- Double (Participant, Investigator)
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
- •Patients with PAOD (Stage III or IV)
- •Distal arterial occlusions
- •Patients with Buergers Disease
- •Signed informed consent
排除标准
- •Successful bypass operation or intervention within the last 3 months
- •Active infection, feber, chronic inflammatory disease
- •HIV, Hepatitis
- •Tumor within the last 5 years, complete remission required
- •Stroke or myocardial infarction within last 3 months
- •Renal insufficiency (creatinine > 2 mg/dl)
- •Liver disease (GOT > 2x upper limit oder spontaneous INR > 1,5).
- •Anemia (hemoglobin < <10 mg/dl)
- •Thrombocytopenia < 100.000/µl
- •Allergies to Aspirin, Clopidogrel, Heparin
- •Bleeding disorder
- •Gastrointestinal bleeding within last 3 months
- •Surgery or trauma within the last 2 months
- •Pregnancy
- •Mental retardation
- •Inclusion in other clinical study within last 30 days
研究组 & 干预措施
1
intraarterial application of bone marrow mononuclear cells
干预措施: intraarterial stem cell therapy (Procedure)
1
intraarterial application of bone marrow mononuclear cells
干预措施: Stem cells (Other)
2
intraarterial application of placebo
干预措施: intraarterial stem cell therapy (Procedure)
2
intraarterial application of placebo
干预措施: Stem cells (Other)
结局指标
主要结局
Ankle brachial index
时间窗: 6 months
次要结局
- TCO2(6 months)
- Walking distance(6 months)
- Ulcer size(6 months)
- Pain(6 months)
研究者
A. M. Zeiher
Prof. Dr. A.M. Zeiher
Johann Wolfgang Goethe University Hospital