Bone Fracture Clinical Trial
Official title:
Pilot Clinical Trial of CPC/rhBMP-2 Microffolds as Bone Substitute for Bone Regeneration
Objective: The investigators initiated a pilot clinical study to test safety and preliminary
efficacy in humans (bone tissue repairing capacity) and to evaluate standard clinical and
rehabilitation protocols.
Summary Background Data: Bone tissue engineering scaffolds loading growth factors have been
considered as the most perspective among all bone substitutes, yet little progress of its
clinical translation has been made. The concept of "micro-scaffolds" was proposed in this
study to provide a trajectory to its clinical translation.
Methods: Pre-cured CPC/rhBMP-2 micro-scaffolds have been successfully developed and further
applied as an easy-to-operate filler for bone regeneration in a pilot clinical study.
Patients of tibial plateau fractures, proximal humeral fractures, or calcaneal fractures at
a similar level of severity were randomly divided into two groups and treated by CPC/rhBMP-2
microffolds or traditional CPC paste (control group).
Objective: The investigators initiated a pilot clinical study to test safety and preliminary
efficacy in humans (bone tissue repairing capacity) and to evaluate standard clinical and
rehabilitation protocols.
Summary Background Data: Bone tissue engineering scaffolds loading growth factors have been
considered as the most perspective among all bone substitutes, yet little progress of its
clinical translation has been made. The concept of "micro-scaffolds" was proposed in this
study to provide a trajectory to its clinical translation.
Methods: Pre-cured CPC/rhBMP-2 micro-scaffolds have been successfully developed and further
applied as an easy-to-operate filler for bone regeneration in a pilot clinical study.
Patients of tibial plateau fractures, proximal humeral fractures, or calcaneal fractures at
a similar level of severity were randomly divided into two groups and treated by CPC/rhBMP-2
microffolds or traditional CPC paste (control group).
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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