Study on Induced Wound Healing Through Application of Expanded Autologous Bone Marrow Stem Cells in Diabetic Patients With Ischemia-induced Chronic Tissue Ulcers Affecting the Lower Limbs
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- The patient is alive, the patient has not undergone any major amputation, complete primary wound healing has been achieved, no ipsilateral relapse has occurred
研究概览
简要总结
Diabetic foot patients with chronic limb ischemia and without the option for surgical or interventional revascularization were recruited and randomized to the transplant groups or the control group within this clinical trial. These patients are randomized to control or intervention group, whereas the intervention is divided into bone marrow cells administered intramuscular or intraarterial or expanded bone marrow cells administered intramuscular or intraarterial resulting in five distinct groups. To measure the therapeutic effects of the various treatment arms patients were evaluated for (ankle brachial index (ABI), transcutaneous oxygen partial pressure (TcPO2), and reactive hyperemia (Blood Oxygen Level Dependent [BOLD]). Patients also underwent imaging with angiographic methods.
详细描述
Diabetic foot (DF) is a concomitant illness of diabetes mellitus. Diabetes is one of the main causes of non-traumatic amputation worldwide due to severe peripheral arterial occlusive disease with chronic critical limb ischemia being the most abundant problem. Ulceration occurs as failure of oxygenation, nutrient supply and progressive occlusion of larger blood vessels often exacerbates pre-existing microvascular abnormalities.
Purified bone marrow mononuclear cells or expanded bone marrow cells enriched in Cluster of Differentiation 90+ (CD90+) mesenchymal stem cells (named tissue repair cells, [TRCs]) are used in the treatment of diabetic ulcers in comparison to bone marrow derived stem cells to induce revascularization of the affected limb and to enhance local perfusion. Cells are administered intramuscular or intraarterial. A control group of patients treated according national guidelines without stem cells serves as comparator.
Diabetic foot patients with chronic limb ischemia and without the option for surgical or interventional revascularization were recruited and randomized to the transplant groups or the control group within this clinical trial. To measure the therapeutic effects of the various treatment arms patients were evaluated for (ankle brachial index (ABI), transcutaneous oxygen partial pressure (TcPO2), and reactive hyperemia (Blood Oxygen Level Dependent [BOLD]). Patients also underwent imaging with angiographic methods.
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
- None
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
- •Diabetes mellitus Type 1 or 2
- •Peripheral occlusive arterial disease stage III or IV (Fontaine) with chronical ischemia, chronic foot ulcer, degree of severity <5 (Wagner), older than 6 weeks, without acute wound infection
- •Ulcer size 1 - 30cm2, in case of osteomyelitis only one bone should be affected no trend towards healing in the ulcer after one week of standard treatment
- •Angiopathic or angioneuropathic diabetic foot syndrome with no possible option of operative or interventional revascularisation
- •Age 18 - 80 years
- •Declaration of patient consent
排除标准
- 未提供
结局指标
主要结局
The patient is alive, the patient has not undergone any major amputation, complete primary wound healing has been achieved, no ipsilateral relapse has occurred
时间窗: 12 months
次要结局
- Rate major amputations Rate of patients with complete ulcer healing Rate of treatment related complications Improvement of ankle brachial index (ABI) Improvement of transcutaneous oxygen partial pressure (TcPO2) Improvement of local perfusion(12 months)
研究者
Diethelm Tschoepe
Prof. Dr. Dr.
Ruhr University of Bochum