The purpose os this study is to evaluate the safety and effectiveness of HC-SVT-1001 and HC-SVT-1002 in the surgical treatment of atrophic nonunion in long bones.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
12
A single application in the context of a single surgical intervention.
Laboratorios Salvat, S.A.
Esplugues de Llobregat, Barcelone, Spain
Safety of HC-SVT-1001 and HC-SVT-1002 in the surgical treatment of atrophic nonunion in long bones by recording of adverse events.
Time frame: Up to 24 months after surgery.
Effectiveness by mean of radiological methods on the appearance of signs of osseous setting formation.
Time frame: Within 6 months after surgery.
Comparative statistical analysis
Comparative statistical analysis between the 12 patients of this study and the data of 14 consecutive cases of refractory nonunion of long bones that have been treated since Sept-2009 with 40x10(6) autologous fat stem adult mesenchymal and under AEMPS compassionate use requirements.
Time frame: Up to 24 months after surgery.
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