Diabetic Foot, Gangrene, Leg Ulcer, Lower Extremity Ischemia, Peripheral Vascular Disease
Conditions
Keywords
Lowe extremity ischemia, Bone marrow, Neoangiogenesis
Brief summary
The purpose of this study is to determine whether autologous bone marrow-derived stem cells are effective in the treatment of lower extremity ischemia.
Detailed description
Critical limb ischemia (CLI) is a debilitating and disabling disease. Symptoms include pain at rest, loss of tissue integrity, distal amputations and have a major impact on the quality of life. Despite recent advances in surgical vascular procedures, a large number of patients (approximately 40%) are not eligible for these revascularization procedures. New strategies for revascularization need to be explored. Besides, in some cases results of such interventions do not give desirable effect, search of new methods of treatment therefore is necessary. Recent evidence indicates that bone marrow-derived mononuclear cells (BM-MNC) are a potential new therapeutic target.
Interventions
PROCEDUREBM-MNC injection
BM-MNC cells will be injected in aliquots of 1 ml at multiple regions of the leg muscles
Sponsors
Instituto de Moléstias Cardiovasculares de São José do Rio Preto, Brazil
Hospital Sao Rafael
Hospital Geral Nacional Enrique Cabrera, Cuba
Instituto de Hematología e Inmunología, Cuba
Fundação Araucária
Pontifícia Universidade Católica do Paraná
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Critical lower limb ischemia, defined as ischemic pain at rest and / or the presence of minor tissue loss, with the possibility of healing. * Failure of conventional medical treatment and attempts to open or percutaneous revascularization before, with an observation period of two months after the last attempt at revascularization. * Patients considered at high risk for new revascularization procedure by at least two independent observers.
Exclusion criteria
* Expected life span less than six months * Large tissue loss in the ischemic limb indicating the need for limb amputation in the short term. * Evidence of osteomyelitis in the ischemic extremity. * Current or previous history of neoplasia. * Unstable angina, recent stroke or other medical condition that contraindicate anesthesia for bone marrow aspiration. * Proliferative retinopathy. * Debilitating disease with a life span less than one year. * Myelofibrosis, myelodysplasia or other diseases that affect the bone marrow. * Use of alcohol in excess of twice-daily doses or history of illicit drug use. * Need for continuous high doses of drug therapy with steroids (more than 7.5 mg/day). * Positivity for HIV or syphilis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Wound healing (wound size, wound stage) - monitoring the healing of trophic lesions | 3 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical outcome classification | 3 months, 6 months | Improvement of symptoms, functional capacity, exercises tolerance assessed by change in Rutherford scale of CLI |
| Pain and analgesics use | 3 months | — |
| Quality of life outcome | 3 months, 6 months | — |
| Improvement of the coronary and collateral circulation. | 3 months | — |
| Survival without amputation | 6 months | — |
Countries
Brazil
Outcome results
None listed