EUCTR2010-019774-33-ES进行中（未招募）1 期
Clinical trial phase I/II multicentric, open, randomized and controlled for the study of stem cells as therapy critical ischemia in low limbs in insulinized type 2 diabetic patients: study of the insulin
Fundación progreso y Salud0 个研究点目标入组 48 人开始时间: 2012年1月12日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 48
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Age 18 and 85 years
- •2. Diabetic type 2, in treatment with insulin at least 3 previous months.
- •3. Vascular disease infrapoplítea aterosclerótica of severe degree (Patients with category Rutherford-Becker 4), mono or bilateral. The critical isquemia of the foot is defined as a persistent / persistent pain that needs analgesia and / or not healing present sores> 4 weeks, without evidence of improvement with conventional therapies and / or walking test between 1-6 minutes in two ergometrías separated at least for 2 weeks and / or index ankle - arm in rest <0,8.
- •4. Impossibility of revascularización surgical or endovascular
- •5. Failure in the surgery of revascularización realized at least 30 days before, with persistence or entry in phase of isquemia critique
- •6. Life expectation> 2 years.
- •7. Major amputation is not foreseen in any of the members in the next 6 months after the recruitment.
- •8. Study trombofilia for the detection of possible factors protrombóticos
- •9. Biochemical parameters and of bony marrow normal, defined for:
- •- leukocytes 3000
- •-Neutrófilos 1500
- •- platelets 140000
- •-AST/ALT 2,5 standard range institution
- •-Creatinina 2,5 mg/dl and explanation of creatinina 30 ml/min (MDRD4)
- •10. The women in fertile age will have to obtain negative results in a pregnancy test realized in the moment of the incorporation in the study and promise to use a contraceptive method medically approved while the study lasts.
- •11. Patients who give his Informed Consent in writing for the participation in the study.
- •12. Patients who have not taken part in another clinical trial in the last 3 months before the recruitment.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 40
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 8
排除标准
- •1. Precedent of neoplasia or hematologic disease (disease mieloproliferativa, syndrome mielodisplásico or leukaemia) in the last 2 years.
- •2. Major previous amputation.
- •3. Patients with arterial uncontrolled hypertension (defined as arterial tension> 180/110 in more than one occasion).
- •4. Cardiac severe insufficiency (NYHA the IVth) or Fraction of Ejection of left ventricle (FAITH) lower than 30 %.
- •5. Patients with ventricular malignant arrhythmias or unstable angina.
- •6. Diagnosis of venous deep thrombosis in 3 previous months.
- •7. Patients with genotype DD of the ECA or genotype E4 of the apo And.
- •8. Infection activates or infects humid the day of infusion of the cells.
- •9. Concomitant therapy that includes oxygen hiperbárico, substances vasoactivas, agents against angiogénesis or inhibiting Cox-II. The agents' use is allowed antiplaquetarios.
- •10. Index of corporal mass> 40 Kg/m2.
- •11. Patients with the diagnosis of alcoholism in the moment of the inclusion.
- •12. Retinopaty proliferative without possibility of treatment.
- •13. Diabetic Nefropatía with hemodiálisis
- •14. Concomitant disease that reduces the life expectation to less than 1 years.
- •15. Impossibility foreseen to obtain the inhaled one of 100ml of bony marrow.
- •16. Infection for HIV, Hepatitis B or Hepatitis C.
- •17. Difficluty to the follow-up.
- •18. ACV or heart attack of myocardium in the last 3 months
- •19. Anemia (Hemoglobin <7.9 g/dl)
- •20. Leucopenia
- •21. Trombocitopenia (<100000 plaquetas/l).
- •22. Patients treated prevously with cellular therapy
- •23. Pregnant women or in fertile age that they do not use contraceptive medically proven method.
研究者
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