Autologous Bone Marrow derived cells for the treatment of chronic arterial Limb Ischemia in patients with high risk of amputation
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Anatomic and functional changes derived from the vasculo/angiogenesis induced by somatic cell therapy: improve in ankle/brachial index, digit/brachial index, transcutaneous oxygen measurement, ischemic ulcer size and maximum walking distance until claudication
研究概览
简要总结
Evaluate the safety, in terms of absence of adverse effects, and the efficacy, in terms of pain decrease, functional improvement and delay or absece of amputation, of the use of BM-MNCs in the treatment of "no option" chronic lim ischemia with risk or amputation. Determine the mot efficient route of administration
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •The patient must have: - age among >= 18 and <= 90 years old - advanced chronic ischemia (fontaine III-IV class and Rutherford IV-V), with risk of amputation of at least one limb - No option of surgical or endovascular revascularization - Life expenctancy > 2 years - Normal hematological parameters: o Leukocytes >= 3000 o Neutrophyles >= 1500 o Platelets >= 140000 - Signed informed consent
排除标准
- •The patient can not have none of those criteria: - history of solid neoplasia or hematological disease (myeloproliferative disease, myelodisplastic syndrome or leukemia) - Rutherford VI stage - Severe Cardiac insuficiency (NYHA IV) or ejection fraction < 30% - Patients with malignant ventricular arrythmia or unstable angina - Diagnosis of deep vein thrombosis on last 3 months - Active systemic infection - Concomitant Therapy with hyperbaric oxygen, agents against angiogenesis or COX-II inhibitors - Body mass Index > 40 Kg/m2 - Infection by VIH, B or C hepatitis, or syphilis - Problems with follow-up - CVA or miocardial infarct on last 3 months - Pregnant women or women in fertile age whithout an adecuate anticonceptive method - To be treated with an Advanced Therapy Medicine Product in the last 12 months.
结局指标
主要结局
Anatomic and functional changes derived from the vasculo/angiogenesis induced by somatic cell therapy: improve in ankle/brachial index, digit/brachial index, transcutaneous oxygen measurement, ischemic ulcer size and maximum walking distance until claudication
Anatomic and functional changes derived from the vasculo/angiogenesis induced by somatic cell therapy: improve in ankle/brachial index, digit/brachial index, transcutaneous oxygen measurement, ischemic ulcer size and maximum walking distance until claudication
次要结局
未报告次要终点
研究者
cell therapy and regenerative medicine unit
Scientific
Fundacion Para La Investigacion Y La Innovacion Biosanitaria Del Principado De Asturias