EUCTR2010-019774-33-ES
Active, not recruiting
Phase 1
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 sites48 target enrollmentJanuary 12, 2012
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Fundación progreso y Salud
- Enrollment
- 48
- Status
- Active, not recruiting
- Last Updated
- 7 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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\.
Outcomes
Primary Outcomes
Not specified
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