Bone Defects Clinical Trial
Official title:
Safety and Efficacy Study of Traumatic Bone Defects Treatment With Use of 3D Tissue Engineered Equivalent.
This study investigates safety and efficacy of traumatic bone defects treatment with use of
3D tissue engineered bone equivalent (3D-TEBE).
The aim of this study is to evaluate 3D-TEBE transplantation as a safe and efficient
treatment for patients with traumatic long bone defects of critical size.
This new method of critical sized long bone defects treatment is under clinical development.
Treatment of critical sized bone defects is an actual clinical challenge. The "gold
standard" in this case is autologous bone grafting. The method disadvantage is associated
with limited donor bone resources. Based on our preliminary clinical trial positive results
on use of autologous cultured bone marrow-derived multipotent mesenchymal stromal cells
(BM-MSCs) in traumatology, our aim was to develop 3D tissue-engineered bone equivalent
transplantation technology for restoration of critical sized bone defects. The proposed
3D-TEBE transplantation for bone defects of critical size treatment expecting to restore the
bone integrity, form new bone tissue in a site of bone defect, and reduce the rehabilitation
period of a patient.
The data obtained from this study will have practical implications for the treatment of
reparative osteogenesis alterations and will be based on the principles of evidence-based
medicine
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