The aim of the study is to determine the safety and feasibility of an autologous mononuclear stem cells infusion in pressure ulcers of paraplegic patients; and moreover, to evaluate the efficacy of the treatment.
Taking into account the encouraging results obtained in the treatment of non-healing chronic wounds using bone marrow cells Given that treatment strategies for pressure ulcers can be both costly and complex, in this study we examine the possibility of improving pressure ulcer healing using stem cell therapy.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
30
Cleaning of the wound with heparinized saline, cell infusion and closing with suture.
Hospital Universitario Central de Asturias
Oviedo, Principality of Asturias, Spain
Absence of adverse effects during timeframe as infections or complications related with the intervention.
The proposed trial will involve the recruitment of a total of 30 patients. The cells will be collected via bone marrow sampling. The aspirate will centrifuged on a Ficoll density gradient to isolate mononuclear cells, wich will be resuspended in heparinized isotonic saline for infusion into the area of the wound. Assessment of adverse events will be by wound examination and laboratory (microbiological)parameters
Time frame: Six months
Improvement and closure of the pressure ulcer
The closure of the ulcer will be assessed by NMR and physical examination
Time frame: One year
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