The aim of the study is to determine the safety and feasibility of autologous mononuclear stem cells in long bone nonunion; and moreover, to evaluate the efficacy of the treatment.
In this study the investigators examine the improvement of conventional surgical treatment of long bone nonunion with the administration of bone marrow stem cells in order to achieve a higher percentage of healing and tissue reparation.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
7
To mix the cell suspension with osteogenic matrix and to use sheet and nails in order to consolidate the fracture
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 be centrifuged on a Ficoll density gradient to isolate mononuclear cells, wich will be resuspended in heparinized isotonic saline and used in order to infuse into the area surgically treated. The surgical intervention means the introduction of a sheet with nails according with the usually employed technique.
Time frame: Six months
Improvement and union of the bone
The improvement of the bone nonunion will be assessed by X-ray and NMR
Time frame: One year
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