Status:
COMPLETED
Intraarterial Infusion of Autologous Bone Marrow in Diabetic Patients With Chronic Ischemia of Lower Limbs (CLI) no Revascularization
Lead Sponsor:
Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud
Collaborating Sponsors:
Iniciativa Andaluza en Terapias Avanzadas
Conditions:
Critical Limb Ischemia (CLI)
Diabetic Foot
Eligibility:
All Genders
18-80 years
Phase:
PHASE1
PHASE2
Brief Summary
The aim of the study is to evaluate the safety and feasibility of autologous bone marrow mononuclear cells autologous administered intra-arterially in the affected limb of diabetic patients with chron...
Detailed Description
Phase II Clinical Trial, a prospective, multicenter, open, randomized, parallel-group controlled with three dose levels. The study population will consist of a total of 60 diabetic patients with chro...
Eligibility Criteria
Inclusion
- Type 1 or 2 diabetes mellitus
- Grade II-III Rutherford-Becker peripheral vascular disease affecting at least one limb
- Arterial obstruction(s) located at infrapopliteal level
- No options of endoarterial or surgical revascularization
- Life expectancy more than 2 years
- Unlikelihood of major amputation of the leg during the next 12 months
- Normal analytical parameters in blood: leucocytes\>3000/micoL, neutrophils\>1500 microL, Hb\>10mg/dl, platelets\>100000 microL,AST and ALT\<2.5 standard value, creatinin\<2.5 mg/dl
- Written informed consent
- Negative pregnancy test when applicable
Exclusion
- History of neoplasm or hematological disease
- Uncontrolled high blood pressure (\>180/110)
- Severe cardiac insufficiency (NYHA IV) or ejection fraction\<30%
- Malignant ventricular arrythmia
- Deep venous thrombosis during the last 3 months
- Active bacterial infection
- Treatment with hyperbaric oxygen, vasoactive drugs, Cox-II inhibitors or antiangiogenic agents
- Body mass index \> 40
- Alcoholism
- Proliferative retinopathy
- HIV, HBV or HCV viral infection
- Stroke or myocardial infarction during the last 3 months
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2013
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00987363
Start Date
July 1 2009
End Date
March 1 2013
Last Update
March 16 2016
Active Locations (5)
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1
Hospital Universitario Reina Sofia
Córdoba, Spain, 14004
2
Hospital Universitario San Cecilio
Granada, Spain, 18012
3
Hospital Universitario Virgen de la Nieves
Granada, Spain, 18014
4
Hospital Universitario Morales Meseguer
Murcia, Spain, 30008