Status:
COMPLETED
Intra-arterial Infusion of Autologous Bone Marrow Mononuclear Cells in Non-diabetic Patients With Critical Limb Ischemia (CLI).
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)
Eligibility:
All Genders
18-89 years
Phase:
PHASE2
Brief Summary
Phase II Clinical Trial, a prospective, multicenter, open, randomized, parallel-group controlled with three levels of dose. The hypothesis of the test we propose is that the mononuclear cells of bone...
Detailed Description
The study population will consist of a total of 44 non-diabetic patients with chronic critical ischemia in at least one of their lower limbs (CLI) and without possibility of revascularization. In the ...
Eligibility Criteria
Inclusion
- Patients of both sexes aged ≥ 18 and ≤ 89 years.
- Non-diabetic.
- Infrapopliteal atherosclerotic vascular disease with severe to severe claudication or Rutherford-Becker grade I-3, II, III, in at least one lower limb. The chronic critical ischemia of the lower limb is defined as persistent / recurring pain requiring analgesia and / or non-healing ulcers present\> 4 weeks, with no evidence of improvement with conventional therapies and / or walking test (stress test) between 1-6 minutes two exercise tests separated by at least 2 weeks and / or ankle-brachial index at rest \<0.8.
- Inability to endovascular or surgical revascularization as recommended by the TransAtlantic Inter-Society Consensus (TASC).
- Failure of the revascularization surgical performed at least 30 days before, either persistently or entry in critical ischemia phase.
- Life expectancy\> 2 years.
- Not expected major amputation in the limb to treat in the next 6 months after inclusion.
- Normal laboratory parameters, defined by:
- Leukocytes ≥ 3000
- Neutrophils ≥ 1500
- Platelets ≥ 100,000
- Aspartate aminotransferase AST) / Alanine aminotransferase (ALT) ≤ 2.5 standard range institution.
- Creatinine ≤ 2.5 mg / dl
- Patients should give their written informed consent to participate in the study.
- Women of childbearing potential must have negative results on a pregnancy test following standard procedures for each hospital performed at the time of inclusion in the study and agree to use a medically approved method of contraception through the duration of the study.
Exclusion
- History of malignancy or hematologic disease (myeloproliferative disease, myelodysplastic syndrome or leukemia)
- Patients with uncontrolled hypertension (defined as blood pressure\> 180/110 on more than one occasion).
- Severe heart failure (New York Heart Association IV).
- Patients with malignant ventricular arrhythmias or unstable angina.
- Diagnosis of deep vein thrombosis in the previous 3 months.
- Active infection or gangrene wet day infusion of mononuclear bone marrow cells.
- Corporal mass index (BMI)\> 40 kg/m2.
- Patients with a diagnosis of alcoholism at the time of inclusion.
- Proliferative retinopathy.
Key Trial Info
Start Date :
January 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2015
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT01408381
Start Date
January 1 2011
End Date
June 1 2015
Last Update
March 16 2016
Active Locations (5)
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1
University Hospital Reina Sofía
Córdoba, Cordoba, Spain, 14004
2
University Hospital Puerta del Mar
Cadiz, Cádiz, Spain, 11009
3
University Hospital Virgen de las Nieves
Granada, Granada, Spain, 18014
4
University Hopistal Carlos Haya
Málaga, Málaga, Spain, 29010