| Background and objectiveAs for the major malpractice in the treatment of long bone defects with the usage of autologous iliac bone, questions were called in by more and more patients and surgeons about the above therapy with the increasingly emphasis on the biopsychosocial medical model in 21st century. At the same time, children patients who are short of autologous bone or adult patients who suffered relapse of the osteopathia or bone nonunion will usually had to accept the donation of their direct relatives for the repair of their large bone defects. Yet bone from relatives which belong to allografts are not considered to be the optimum selection for the bone implantation, let alone the second attack on the family members both physiologically and psychologically by this kind of operation. Investigators throughout the world have attempted so many artificial materials to substitue with the autologous bone as a gold standard, but intrinsic defectiveness does exist when comes to a large bone mass being implanted no matter autologous bone or artificial materials. As we have gained so many breakthroughs on the research of repairing large bone defect of big animals using tissue-engineered bone, it is necessary to carry out some clinical experiments restrainedly for the sake of the TEB's formal clinical applications and the accumulation of rudiment data in order to form an orthonormal therapy mode for long bone defect.The research was authorized by the Ethics Committee of Southwest Hospital.Methods1. Individualized TEB was constructed according to the SOP for the clinical application in the treatment of long bone defects 3-4 weeks before the admission. In this procedure, strict screening and detections based on SOP were carried out on the target cells or tissues in different phases of the TEB construction. Commitments of the subject's physical security are sticked to from the beginning to the end in this research.2. Patients were informed to hospitalization after TEB was constructed, all the perioperative check-ups, follow-up visits and the long-term developmental communicationsbetween the subjects and the clinicians during the restoration were executed according to the clinical path for these patients only. An identical resident is appointed to accomplish the above work, which is responsible to find out possible problems promptly and provide helpful recommendations for the subjects. The evaluation of the curative effect was mainly through the persistent monitoring of the radiology and hemotolgy results.3. Nude mice of 6 weeks old (male:female=l:l) were chosen to be the host of the implantation subcutaneously and were evaluated the osteogenesis or oncogenicity by periodic check through X-ray, pathological slice, histochemical stain of the graft and the vital organs respectively.Results1. Rapid proliferation, efficient induction and differentiation of the seedling cells were observed in the construction of TEB, productive secretion of the cell matrix was found in almost every pore under the inverted phase contrast microscope.2. Clinical probation of twenty-six cases were finished strictly according to the SOP of TEB with the self-contained follow-up materials obtained simultaneously. According to the materials, comparatively high-density calcification domain appeared 3 months after the implantation when capsular bone defect cases were studied, the foci almost disappeared at about 12 months after the operation, and to our anticipation, cavum pulpi were found completely recanalized in the 1.5 years case. Gap of the segmental bone defects varies from 1 to 4 cm, bone callous was found across the gap 6 months after the implantation and marrow cavum was observed by CT scan in most of the cases 1 year postoperatively.3. Ectopia osteogenesis experiment on nude mice demonstrated gradually ossification post-operation. Both the internal and the external part of the tissue have formation signs of woven bone with major osteoblasts and small vessles infiltration. No obvious change of life habit was investigated and no tumor-like tissue was discovered by HE staining of the slice from the heart, lung, liver and kidney of the mice injected with cell suspensions.Conclusion1. No visible rejections was found during the application of individualized TEB for the treatment of patients with long bone defects, which implies that the constructed TEB has good histocompatibility and extensive prospects for clinical application.2. Both the result of the clinical application and ectopia osteogenesis experiment innude mice showed comparatively doughty bone induction and osteogenesis of TEB at the same time.3. The biological security and curative effect of TEB in the treatment of different kinds of long bone defects were tentatively confirmed by monitoring the serology and imageology results of the patients in differents periods of rehabilitation dynamically.4. Felicitous curative results were manifested in the treatments of children's long bone defects with individualized TEB, which provided a novel path for the theraphy of juvenile bone defects casued by different etiological factors. |
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