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We have conducted efficacy and safety testings using 13 beagles sice 2004. As a result, neither local nor systemic adverse reaction was observed from general health condition observation, blood tests and x-ray CT scannings. In efficacy confirmation, we implanted CT-Bone and existing bone implant as control, and had measured HU for 24 weeks. Compared with HU in control, that in CT-Bone showed significant increment. Besides, histlogical stains show bone tissue invasion into macropores and bone marrow formation with erythroblasts and megakaryocytes. 
 We have already finished clinical study with 10 patients in The University of Tokyo Hospital.


仭 Implants
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Material
Characteristics
Porosity
Fabrication method
CT-Bone 兛-tricalcium phosphate 乮兛-TCP乯 Un-sintered, connecting pores
48%
Three dimensional lamination method by ink-jet printing technology.
Existing artificial bone products Hydroxyapatite 乮HA乯 Sintered porous material
55%
Cut by hand from the block
丂 丂
仭 Fabrication method
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仭 CT findings
Narrowing of connecting macropores and bridge formation between CT-Bone and bone stump are observed.


Immediately 
after surgery

4 weeks after


24 weeks after

                            Apacerum丂              CT-Bone                  Apacerum丂          丂CT-Bone
仭 HU analysis
CT-Bone shows significantly more increment in HU than Apacerum.
                    Profile Line                                                                Profile Line

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仭 Histologic findings
乮侾乯HE staining
In Apacerum, osteocytes were found only in its body. In CT-Bone, bone-like tissue penetrates into connecting macropores. In addition, bone marrow formation was observed, with erythroblasts pointed by the blue arrow and megakaryocytes pointed by the yellow arrow.
乮俀乯MT staining
Blue collagenous fibers and bone tissues penetrate into Apacerum body and mactopores of CT-Bone.
乮俁乯TRAP staining
TRAP stain shows osteoclasts pointed by the orange arrow.

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仭 Application to animal patient
丒Corgi Dog suffering from bone sarcoma underwent tumor resection, and CT-Bone was implanted to the bone defect site.
丒Granulomas was removed in implantation. Implant was performed on 19th July, 2005.
丒The patient dog has been followed up by blood tests and CT scanning, showing steady recovery.
     丂丂丂丂丂丂The implanted CT-Bone                             The patient dog looks fine.
丒Temporal profile of CT of the implanted site
丂 丂丂丂丂丂Immediately after surgery丂丂3 months after 丂丂丂  7 months after丂丂丂丂10 months after
丂 HU339乣3071

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HU110乣3071丂丂丂丂丂丂

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