Allogeneic Bone Matrix Research Articles

Treated Pierre Robin Sequence Using Placed Allogenic Acellular Bone Matrix and Mandibular Distraction Osteogenesis in the Neonate

ObjectiveThe aim of the study was to report our experience with placed allogenic acellular bone matrix and mandibular distraction osteogenesis in Pierre Robin sequence (PRS), and explore the role of distraction in the osteogenesis of acellular bone.Materials and MethodsA total of 428 neonates with severe PRS managed with placing allogenic acellular bone and bilateral mandibular distraction osteogenesis were included in the study. The procedure included using oblique-shaped osteotomy, fixing bilateral mandibular distractor, instantly extending a 4–6 mm gap, and placing allogenic acellular bone into the gap. The length of allogenic acellular bone was 4–5 mm. Although the surgical techniques, distraction, and consolidation periods were similar, the allogenic acellular bone matrix we placed was quite different from the traditional distraction. With the technology we used, tracheal intubation could be immediately removed, thus quickly improving breathing conditions compared to traditional methods after the surgery. The jaw extending and oral feeding could begin on the 5th day. The jaw was extended 0.6 mm twice a day until the mandible was overcorrected by 20%.ResultsAll 428 cases included in this study were successfully extubated after the operation, and the difficulty in breathing was instantly relieved. Total mandibular distraction was 15–20 mm. Oral feeding was started at 6 h to 6 days postoperatively, while hospital stay ranged from 18 to 20 days postoperatively. No major complications were reported. Medium to long-term results was good. Mandibular distractors were removed after 3 months.ConclusionsBilateral mandibular distraction osteogenesis combined with placing allogenic acellular bone in the neonate are safe and accurate procedures, which are the primary treatment options for cases of severe PRS. It can be considered that the tension of distraction can promote osteogenesis in acellular bone and thus improve distractive effect of the mandible.

Evaluation of in vitro biocompatibility of scaffolds for the repair of bone defects

The use of bone scaffolds in traumatology and orthopedics is an extremely important issue. The growing number of cases of significant bone defects, in particular after revision arthroplasty, combat trauma and due to the introduction of new methods of reconstructive surgery of bones and joints, requires more detailed studies of the using different osteoplastic materials. Materials and methods. As scaffolds used 4 types of materials that are most often used in the clinic for the correction of bone defects - ceramic hydroxylapatite, beta-tricalcium phosphate, allogeneic bone matrix treated with gamma irradiation, allogeneic bone matrix scaffold. The effect of matrices on the viability of normal human fibroblasts (M19 cell line) in cell culture in vitro was studied. The viability of cells after their co-cultivation with scaffolds was determined by colorimetric method by staining with crystal violet. To obtain an osteoinductive effect used platelet-rich plasma (PRP), standardized by the method of Araki with some modifications. The proliferative activity of fibroblasts was assessed by the level of expression of the proliferation marker Ki-67 by immunocytochemical analysis. Results. It was found that the least pronounced antiproliferative effect is shown by allogeneic bone matrix treated with gamma irradiation. Data on the complex effect of co-cultivation of fibroblasts with scaffolds in the presence of PRP on cell viability and proliferative activity were obtained. It was found that PRP improves the survival of fibroblasts by 15-30 % and increases their proliferative activity by 35-75 %. Delipidization of scaffold from allogeneic bone matrix, heat-treated by local bone bank technology, increased its biocompatibility with human fibroblasts. Conclusions. According to the results of a comparative analysis of the impact of different scaffolds on the viability of normal human fibroblasts, it was found that scaffolds from allogeneic bone matrix have the least pronounced antiproliferative effect. Platelet-rich plasma has been shown to improve fibroblast survival and increase their proliferative activity. Treatment with 70 % ethyl alcohol scaffold from allogeneic bone matrix, heat-treated by local bone bank technology, increased its biocompatibility with human fibroblasts.

Lateral lumbar interbody fusion using a cellular allogeneic bone matrix in the treatment of symptomatic degenerative lumbar disc disease and lumbar spinal instability.

Cellular allogeneic bone grafts are used as a biologic adjuvant in lumbar spinal fusions. The clinical use of a minimally invasive extreme lateral approach to the lumbar spine has been widely adopted; however, there are few clinical studies that have documented the clinical and radiographic outcomes associated with the use of cellular allografts as an adjunct to fusion in this advanced surgical approach. A consecutive series of 67 patients (34 males and 33 females) with a mean age of 66.8 years (26-85 years) who underwent single- or multilevel lateral lumbar interbody fusion (LLIF) with supplemental posterior segmental spinal fixation using a cellular allogeneic bone matrix as the only bone graft material was retrospectively reviewed by a single surgeon. Patients' preoperative and 3- and 12-month postoperative data were studied. All patients were followed for a minimum of 12 months. Standardized clinical outcome measures-36-Item Short Form Surgery (SF-36), Oswestry Disability Index (ODI), and visual analog scale (VAS) back and leg pain scores-were used to evaluate the clinical outcomes. An average of 2.25 levels was treated per patient (151 total levels). Fusion status was assessed by dynamic radiographs and computed tomography (CT) scans. The statistical method used to identify the significance of the observed changes in clinical outcomes was the paired 2-sided t-tests. Significance was ascribed to P values <0.05. Fusion was achieved at 142 levels (142/151; 94%). Eight levels (8/151; 5.3%) showed partial fusions and one patient (single level) had no fusion. In the group of patients with fusions, the mean back and leg pain scores showed improvement from preoperative scores at both 3 and 12 months (P<0.001). Functional outcomes showed similar clinical success in both in SF-36 and ODI scores. The use of a cellular allogeneic bone matrix provided osteoconductive and osteoinductive components for successful spine fusions and was associated with statistically significant improvement in SF-36, VAS, and ODI scores.

No Detectable Alteration of Inorganic Allogeneic Bone Matrix Colonizing Mesenchymal Cells: A Step Towards Personalized Bone Grafts.

BackgroundDuring major bone substance loss, secured allogeneic bone matrix (ABM) is normally utilized for bone repair. Here, we propose a method to colonize ABM using autologous mesenchymal cells (MCs) to improve their integration. Moreover, in this study, the consequences of in vitro colonization on MCs have been evaluated.MethodsAfter in vitro propagation of MCs, their proliferation kinetics on ABM pre-coated with gelatin, fibronectin, collagen IV and human serum (HS) was monitored, and they were compared with cells cultured without ABM for 8 weeks. The effect of ABM on cell phenotype was also assessed. Lastly, the ability of ABM-colonizing MCs to perform hematopoiesis, a function normally preserved in selected culture conditions, and their differentiation towards osteoblastic lineage were evaluated.ResultsMC and colony-forming unit-fibroblast proliferated 930- and 590-fold, respectively. The proliferation rate of the expanded MCs was higher, forming a 3-dimensional structure in all ABMs. Pre-coating with HS was the most efficient treatment of ABMs to increase the initial adherence of MCs, and it partly explains the reason for the higher propagation of MCs. Flow cytometry analyses revealed subtle alterations in ABM-colonizing cells; however, the ability of MCs to maintain long-term culture initiating cells proliferation and differentiate into osteoblastic lineage was preserved.ConclusionsIn this study, the in vitro biocompatibility of bone marrow (BM) MCs with ABMs, the role of HS in scaffold coating, and the possibility of initially using a small BM sample for this approach were demonstrated.

In Vitro Evaluation of the Allogeneic Bone Matrix Effect on the Adipose Mesenchymal Stromal Cells Characteristics in Combined Tissue Engineering

The aim of the study was to evaluate in vitro the effect of native and deproteinized compact and spongy allogenic bone matrices on the characteristics of adipose mesenchymal stromal cells (ASC) in combined tissue engineering.Material and Methods. 24 samples of native and deproteinized compact and spongy bone were examined, which were exposed to mechanical treatment, modeling, followed by sterilization of the samples by ionizing radiation and bacteriological control of sterilization. Some of the samples underwent deproteinization. The characterized cultures of human ASC were used as test cultures to assess the interaction with the bone samples. The Cytation-5 fluorescent imager and Hoechst 3334 fluorochromes (BD Pharmingen™) and calcein (Calcein AM, BD Pharmingen™) were used to characterize the degree of adhesion, migration, and viability of ASC on bone matrix samples. Matrix cytotoxicity was evaluated by MTT assay on days 1 and 7 of extraction.Results. The bone matrix samples are characterized by the absence of cytotoxicity (rank 1). ASC demonstrated good adhesion and migration on any surface of the bone matrix and preservation of cell viability during 7 days of observation. Nuclei sizes of the cells adhered to the deproteinized bone matrix of the spongy structure increased by 25–30% compared to other samples. The cells on deproteinized bone matrix had greater size (the size of the cells from nuclei 8.8 to 11.5 μm, the average size of cells nuclei from an 86.3 μm to 129,0 μm, the average perimeter of the cells nuclei from 30.7 μm to 40.7 μm) than in the native bone matrix samples.Conclusion. The results of the study of various allogeneic bone matrices demonstrate that deep purification of the bone matrix determines the absence of cytotoxicity and the most favorable conditions for the adhesion, migration, proliferation and viability of ASC. Also makes it possible to use tissue engineering based on bone matrices of different structures. Deproteinized spongy bone matrices are best suited for this purpose.

A Retrospective Analysis of Outcomes from Foot and Ankle Arthrodesis and Open Reduction and Internal Fixation using Cellular Bone Allograft Augmentation

Category:Other; Ankle; Basic Sciences/Biologics; Hindfoot; Midfoot/ForefootIntroduction/Purpose:Surgical arthrodesis of joints in the foot and ankle is common in patients who have failed nonoperative management for a variety of conditions. ViviGen is an allogeneic cellular bone matrix product that contains lineage-committed bone cells, and can be used as an alternative to autograft bone or other augments in order to aid in arthrodesis or to enhance bony healing in open reduction and internal fixation (ORIF) procedures. However, compared with autograft bone, ViviGen does not introduce potential for donor site morbidity. Due to the lack of studies examining outcomes following foot and ankle surgeries in which ViviGen is utilized, further investigation is required to determine its efficacy and safety for use in foot and ankle joint arthrodesis and skeletal fracture fixation.Methods:This study included 153 consecutive patients undergoing ankle, midfoot or hindfoot arthrodesis or ORIF procedures in which ViviGen was used as an augment. Pediatric patients and cases involving structural allografts or metal wedges were excluded. Patients were not excluded based on the amount of ViviGen used, type of instrumentation or implants used, or due to comorbidity. This series included revision as well as primary arthrodesis procedures and included various fixation types. Retrospective chart review was used to identify patient demographic factors and medical comorbidities, as well as to evaluate clinical and radiographic data to determine outcome.Results:135 patients were available for analysis at final evaluation. 113 patients underwent arthrodesis (mean age of 56.29 years, mean body mass index of 32.19). 22 patients underwent an ORIF procedure (mean age of 36.35 years, mean body mass index of 32.79). The fusion rate for the arthrodesis cohort was 97/113 (85.8%). Table 1 demonstrates the fusion rate stratified by region of the foot. Smokers had significantly lower rates of fusion compared to nonsmokers (p=0.01). There was not a statistically significant difference in the rate of fusion between primary and revision arthrodesis (p=0.8650). The rate of fusion was significantly lower in patients with Charcot foot in comparison to patients without Charcot foot (p=0.0076). The bony healing rate for the ORIF cohort was 19/22 (86.4%).Conclusion:This large case series of patients undergoing a wide variety of procedures about the ankle, hindfoot, and midfoot with ViviGen bone graft augmentation demonstrates satisfactory outcomes with regard to fusion rate and successful union, as well as minimal complications. To date, this is the largest case series in the literature of patients undergoing foot and ankle procedures with an allogenic cellular bone matrix product that contains lineage-committed bone cells. Our findings help to introduce ViviGen as a safe and efficacious alternative to other forms of augmentation for fusion and ORIF procedures about the foot and ankle.

A Retrospective Analysis of Outcomes From Foot and Ankle Arthrodesis and Open Reduction and Internal Fixation Using Cellular Bone Allograft Augmentation.

ViviGen is an allogeneic cellular bone matrix product containing lineage-committed bone cells, and can be used as an alternative to autograft bone or other augments to aid in arthrodesis or to enhance bony healing in open reduction and internal fixation (ORIF) procedures. This study included 153 consecutive patients undergoing ankle, midfoot, or hindfoot arthrodesis or ORIF procedures from January 2017 to October 2018, in which an allogeneic cellular bone matrix product was used to aid in bony healing. Retrospective chart review identified patient demographic factors and medical comorbidities and evaluated clinical and radiographic data to determine fusion/union rate and complications. The overall fusion rate for the arthrodesis cohort was 97/113 (85.8%). The overall complication rate in this cohort was 22/113 (19.5%). Smokers had significantly lower rates of fusion compared with nonsmokers (P = .01). The observed bony healing rate for the ORIF cohort was 19/22 (86.4%), with a complication rate of 3/22 (13.6%). With satisfactory fusion rates and relatively few complications, our findings suggest that ViviGen is a safe and efficacious alternative to other forms of bone graft augmentation for fusion and ORIF procedures about the foot and ankle. Further study is needed to compare the efficacy of ViviGen with autograft bone and other augments. Level IV: Case series.

Dynamics of reparative histogenesis of bone tissue in presence of some osteoplastic materials in vitro

Currently, to solve the bone deficiency problem in the maxillofacial region, osteoplastic materials based on allogeneic and xenogenic collagen bone matrix are used, both in pure and in activated forms, by adding growth factors. It is impossible to determine the effectiveness and mechanisms of the osteoplastic materials effect on bone regeneration without a comprehensive study, including not only histological, but also morphometric studies of the structural components and cellular reactions in the impact area. Such studies provide reliable and objective information on the main processes taking place in bone regeneration.Purpose. To determine the spatial distribution of reparative osteogenesis in the presence of some osteoplastic materials in vitro.Materials and methods. Svetlogorsk breed pigs were used as a biomodel. Depending on the osteoplastic preparations used, the animals were divided into four groups of the two in each: 1st — a preparation based on a natural bovine bone graft was injected into bone defects. 2nd — a preparation based on collagenized porcine transplant was injected into bone defects. 3rd — a preparation consisting of 60 % hydroxyapatite (HA) and 40 % beta-tri-calcium phosphate; 4th — control group — the bone defect healed under a blood clot. Animals were removed from the experiment on the 45th day. We examined sections with a thickness of 20 μm using the method of light and fluorescence microscopy.Results. The results indicate different dynamics of the reparative osteogenesis in the presence of osteoplastic materials of different classes. In group 1, the filling of the defect with newly formed bone tissue is not uniform; in group 2, the filling of the defect with newly formed bone tissue is uniform; in group 3 the filling of the defect with non-formed bone tissue is uneven due to the pronounced hyperostosis; in the control group, the filling of the defect with newly formed bone tissue is not happening.Conclusion. Stimulation, the dynamics of reparative osteogenesis and the three-dimensional organization of bone regenerate depend on the osteoplastic material class, which requires further study of the dynamics and three-dimensional organization of bone regenerate to select the optimal bone-replacing agent.

Balancing Purification and Ultrastructure of Naturally Derived Bone Blocks for Bone Regeneration: Report of the Purification Effort of Two Bone Blocks.

The present publication reports the purification effort of two natural bone blocks, that is, an allogeneic bone block (maxgraft®, botiss biomaterials GmbH, Zossen, Germany) and a xenogeneic block (SMARTBONE®, IBI S.A., Mezzovico-Vira, Switzerland) in addition to previously published results based on histology. Furthermore, specialized scanning electron microscopy (SEM) and in vitro analyses (XTT, BrdU, LDH) for testing of the cytocompatibility based on ISO 10993-5/-12 have been conducted. The microscopic analyses showed that both bone blocks possess a trabecular structure with a lamellar subarrangement. In the case of the xenogeneic bone block, only minor remnants of collagenous structures were found, while in contrast high amounts of collagen were found associated with the allogeneic bone matrix. Furthermore, only island-like remnants of the polymer coating in case of the xenogeneic bone substitute seemed to be detectable. Finally, no remaining cells or cellular remnants were found in both bone blocks. The in vitro analyses showed that both bone blocks are biocompatible. Altogether, the purification level of both bone blocks seems to be favorable for bone tissue regeneration without the risk for inflammatory responses or graft rejection. Moreover, the analysis of the maxgraft® bone block showed that the underlying purification process allows for preserving not only the calcified bone matrix but also high amounts of the intertrabecular collagen matrix.

PHP120 - Characteristics and Rate of Subsequent Lumbar Spine Fusion Surgery Among Patients Treated with Allogenic Cellular Bone Matrix for Posterior Lumbar Spinal Fusion

Published literature indicates that posterior lumbar spinal fusion (PSF) is associated with a mean 3.4-day hospital length of stay (LOS) and as high as a 6% rate of subsequent lumbar spine fusion (SLSF) within 12 months. New allograft material, such as Vivigen® Cellular Bone Matrix (CBM), combine osteoconductive, osteoinductive and osteogenic properties and may be used during spinal procedures to promote arthrodesis. This study evaluated patient characteristics, LOS and incidence of SLSF among PSF patients treated with Vivigen CBM. We queried the Premier Healthcare Database® (2013-2016) using ICD-9/10 codes to identify patients who received 1-2 level posterior lumbar fusion with a concurrent hospital charge for ViviGen CBM (LifeNet Health®, Virginia Beach, VA). Patients’ demographics, clinical characteristics, and procedural details were collected and analyzed. Hospital LOS for the index hospitalization and the incidence of SLSF within one year of index surgery were evaluated. The evaluation of SLSF included only those patients from hospitals that continuously contributed data to the database for at least one year after index PSF. This study included 685 patients with a mean (SD) age of 61.5 (12.0) years. The majority of patients were female (59.0%). Medicare was the predominant payer (52.7%) followed by commercial insurance (32.4%). Common comorbidities included hypertension (61.9%), diabetes (22.3%), depression (20.3%) and obesity (17.3%). Mean (SD) LOS was 2.8 (1.8) days. Among the 178 patients with one year follow-up hospital data after index fusion, 1.7% (95% CI: 0.3%-4.8%) had a SLSF within one year. This study provides initial real-world insights into the patient population and one-year outcomes for patients who received ViviGen during PSF. Future research with greater statistical power as well as direct comparative data will further our understanding of the value of Vivigen CBM.

Use of Allogenic Mesenchymal Cellular Bone Matrix in Anterior and Posterior Cervical Spinal Fusion: A Case Series of 21 Patients.

Study DesignRetrospective case series.PurposeTo report our early experience using allogenic mesenchymal cellular bone matrix (CBM) products in cervical spine fusion.Overview of LiteratureMulti-level cervical fusions have historically yielded lower fusion rates than single level fusions, especially in patients with high risk medical comorbidities. At this time, significant literature in cervical fusion outcomes with this cellular allograft technology is lacking.MethodsTwenty-one patients underwent either multilevel (3 or 4 level) anterior cervical discectomy and fusion, anterior cervical corpectomy and fusion, or posterior cervical fusion. ViviGen (DePuy Synthes Spine, Raynham, MA, USA), an allogenic bone matrix product, was used in addition to standard instrumentation. Radiographic evaluation was performed at 2 weeks, 12 weeks, 24 weeks and 1 year postoperative. Visual analog scale (VAS) and neck disability index (NDI) scores along with return to work and leisure activity were recorded.ResultsAt 6 months postoperative, all patients had radiographic evidence of bone fusion regardless of age or medical comorbidities. All patients reported subjective improvement with a mean decrease in VAS from 8.3 to 1.5 and a mean decrease in NDI from 40.3% to 6.0% at 1 year. All patients also returned to work and/or regular leisure activity within 3 months.ConclusionsTwenty-one patients undergoing high-risk anterior and posterior cervical spine fusion, with the use of a commercially available mesenchymal CBM product, went on to radiographic fusion and all had improvement in subjective outcomes. While further effort and research is needed to validate its widespread use, this study shows favorable use of CBM in cervical fusion for high-risk cases.

Prospective clinical and radiographic evaluation of an allogeneic bone matrix containing stem cells (Trinity Evolution\xae Viable Cellular Bone Matrix) in patients undergoing two-level anterior cervical discectomy and fusion

BackgroundTrinity Evolution® (TE), a viable cellular bone allograft, previously demonstrated high fusion rates and no safety-related concerns after single-level anterior cervical discectomy and fusion (ACDF) procedures. This prospective multicenter clinical study was performed to assess the radiographic and clinical outcomes of TE in subjects undergoing two-level ACDF procedures.MethodsIn a prospective, multicenter study, 40 subjects that presented with symptomatic cervical degeneration at two adjacent vertebral levels underwent instrumented ACDF using TE autograft substitute in a polyetherethereketone (PEEK) cage. At 12 months, radiographic fusion status was evaluated by dynamic motion plain radiographs and thin cut CT with multiplanar reconstruction by a panel that was blinded to clinical outcome. Fusion success was defined by angular motion (≤4°) and the presence of bridging bone across the adjacent vertebral endplates. Clinical pain and function assessments included the Neck Disability Index (NDI), neck and arm pain as evaluated by visual analog scales (VAS), and SF-36 at both 6 and 12 months.ResultsAt both 6 and 12 months, all clinical outcome scores (SF-36, NDI, and VAS pain) improved significantly (p < 0.05) compared to baseline values. There were no adverse events or infections that were attributed to the graft material, no subjects that required revisions, and no significant decreases to mean neurological evaluations at any time as compared to baseline. At 12 months, the per subject and per level fusion rate was 89.4 and 93.4%, respectively. Subgroup analysis of subjects with risk factors for pseudoarthrosis (current or former smokers, diabetic, or obese/extremely obese) compared to those without risk factors demonstrated no significant differences in fusion rates.ConclusionsPatients undergoing two-level ACDF with TE in combination with a PEEK interbody spacer and supplemental anterior fixation had a high rate of fusion success without any serious adverse events related to the graft material.Trial registrationTrinity Evolution in Anterior Cervical Disectomy and Fusion (ACDF) NCT00951938

Clinical evaluation of an allogeneic bone matrix containing viable osteogenic cells in patients undergoing one- and two-level posterolateral lumbar arthrodesis with decompressive laminectomy.

BackgroundTrinity Evolution® cellular bone allograft (TE) possesses the osteogenic, osteoinductive, and osteoconductive elements essential for bone healing. The purpose of this study is to evaluate the radiographic and clinical outcomes when TE is used as a graft extender in combination with locally derived bone in one- and two-level instrumented lumbar posterolateral arthrodeses.MethodsIn this retrospective evaluation, a consecutive series of subject charts that had posterolateral arthrodesis with TE and a 12-month radiographic follow-up were evaluated. All subjects were diagnosed with degenerative disc disease, radiculopathy, stenosis, and decreased disc height. At 2 weeks and at 3 and 12 months, plain radiographs were performed and the subject’s back and leg pain (VAS) was recorded. An evaluation of fusion status was performed at 12 months.ResultsThe population consisted of 43 subjects and 47 arthrodeses. At 12 months, a fusion rate of 90.7 % of subjects and 89.4 % of surgical levels was observed. High-risk subjects (e.g., diabetes, tobacco use, etc.) had fusion rates comparable to normal patients. Compared with the preoperative leg or back pain level, the postoperative pain levels were significantly (p < 0.0001) improved at every time point. There were no adverse events attributable to TE.ConclusionsFusion rates using TE were higher than or comparable to fusion rates with autologous iliac crest bone graft that have been reported in the recent literature for posterolateral fusion procedures, and TE fusion rates were not adversely affected by several high-risk patient factors. The positive results provide confidence that TE can safely replace autologous iliac crest bone graft when used as a bone graft extender in combination with locally derived bone in the setting of posterolateral lumbar arthrodesis in patients with or without risk factors for compromised bone healing.Trial registrationBecause of the retrospective nature of this study, the trial was not registered.

Acceleration of callus formation during fracture healing using basic fibroblast growth factor-kidney disease domain-collagen-binding domain fusion protein combined with allogenic demineralized bone powder.

BackgroundTo repair fractures with large bone defects or gaps, demineralized allogenic bone matrix (DBM) is often applied to the fracture site. However, studies have shown that the use of DBM alone has limited efficacy for repairing fractures. In the present study, we developed an allogenic demineralized bone powder (DBP) with basic fibroblast-derived growth factor containing a polycystic kidney disease (PKD) domain and collagen-binding domain (CBD) from Clostridium histolyticum collagenase (ColH) and investigated the stimulatory effects of bFGF-PKD-CBD combined with allogenic DBP on bone growth in a mouse femur fracture model.MethodsDBP mixed with either phosphate-buffered saline (PBS) (DBP/PBS), 0.58 nmol basic fibroblast growth factor (bFGF) (0.58 nmol DBP/bFGF), 0.058 nmol bFGF-PKD-CBD (0.058 nmol DBP/bFGF-PKD-CBD), or 0.58 nmol bFGF-PKD-CBD (0.58 nmol DBP/bFGF-PKD-CBD) was grafted into fracture sites.ResultsbFGF-PKD-CBD/DBP composite accelerates callus formation in a bone fracture model in mice and clearly showed that the composite also increases bone mineral density at fracture sites compared to bFGF/DBP. In addition, bFGF-PKD-CBD/DBP increased callus volume and bone mineral content to similar levels in fractures treated with a tenfold higher amount of bFGF at 4 weeks.ConclusionsOur results suggest that bFGF-PKD-CBD/DBP may be useful for promoting fracture healing in the clinical setting.

Evaluation of Allogenic Cellular Bone Graft for Ridge Augmentation: A Case Report

Introduction: The reconstruction of alveolar bone defects is often necessary to support successful implant therapy. Although multiple technologies are available to achieve ridge augmentation, the most widely used approaches combine an acellular graft material with guided bone regeneration. Recent advances in tissue banking make it possible to preserve mesenchymal stem cells and osteoprogenitor cells as part of an allogeneic cellular bone matrix that can further enhance the ability of the graft material to provide optimal results for ridge augmentation.Case Presentation: This case report describes the clinical application and results of an allogenic bone matrix product retaining mesenchymal stem and osteoprogenitor cells for alveolar ridge augmentation before implant rehabilitation. The cellular bone matrix supported a radiographic gain of 4 to 6 mm in horizontal ridge width, permitting the placement of dental implants without secondary augmentation.Conclusion: Cellular bone matrix appears to provide an important clinical alternative to acellular bone replacement grafts, particularly in light of its potential to achieve substantial gains in bone volume.

The comparative efficacy of decalcified allogenic bone matrix and intra-oral free osseous autografts in the treatment of periodontal intrabony defects

Background and Objectives:The primary goal of periodontal treatment is the maintenance of the natural dentition in health and comfortable function. The shift in therapeutic concepts from resection to regeneration has significantly impacted the practice of periodontology. The objective of the present study is to compare the relative efficacy of intra-oral autogenous graft and decalcified allogenic bone matrix (DABM) in the treatment of periodontal intrabony defects.Materials and Methods:In the present study, 30 patients in the age group of 30-50 years with two almost identical intrabony defects, on either side of the mouth/upper and lower jaw, based upon the radiographic observations were selected from amongst the patients visiting the Department of Periodontology and Oral Medicine, Punjab Government Dental College and Hospital, Amritsar. One of the defect was selected randomly and filled with autogenous cancellous graft and the other with DABM. Post-operative assessment was done by taking radiographs, 12 weeks and 24 weeks post-operatively.Results:Definite bone fill was achieved both with intra-oral free osseous autograft and with DABM at 12 weeks observation, which further increased significantly at 24 weeks observation. The bone fill obtained with intra-oral free osseous autograft was found to be significantly higher than that with DABM both at 12 weeks and 24 weeks post-operative observation.Conclusion:Within the limitations of this study, it establishes the superiority of the intra-oral free osseous autograft over that of DABM graft in correcting the intrabony defects.

Guided bone regeneration using demineralized allogenic bone matrix with calcium sulfate: case series

PURPOSEThe purpose of this case series was to evaluate the effect of guided bone regeneration using demineralized allogenic bone matrix with calcium sulfate.MATERIALS AND METHODSGuided bone regeneration using Demineralized Allogenic Bone Matrix with Calcium Sulfate (AlloMatrix™, Wright. USA) was performed at the time of implant placement from February 2010 to April 2010. At the time of the second surgery, clinical evaluation of bone healing and histologic evaluation were performed. The study included 10 patients, and 23 implants were placed. The extent of bony defects around implants was determined by measuring the horizontal and vertical bone defects using a periodontal probe from the mesial, distal, buccal, and lingual sides and calculating the mean and standard deviation of these measurements. Wedge-shaped tissue samples were obtained from 3 patients and histologic examination was performed.RESULTSIn clinical evaluation, it was observed that horizontal bone defects were completely healed with new bones, and in the vertical bone defect area, 15.1% of the original defect area remained. In 3 patients, histological tests were performed, and 16.7-41.7% new bone formation was confirmed. Bone graft materials slowly underwent resorption over time.CONCLUSIONAlloMatrix™ is an allograft material that can be readily manipulated. It does not require the use of barrier membranes, and good bone regeneration can be achieved with time.

Heterotopic osteogenesis induced by implantation of allogenic bone matrix graft into mouse muscle perimysium. A morphometric study

Heterotopic osteogenesis induced by allogenic bone matrix graft in the mouse muscle was analyzed by radiography, morphology and morphometry. Diaphyses of the femurs of 18 fifty-day-old mice were demineralized with 0.6 M HCl and implanted into the adductor muscle of the right thigh of 36 mice. Two, 5, 7, 14, 21 and 28 days after implantation, groups of 6 animals/period were sacrificed and radiographied, and specimens were collected and processed histologically. The presence of mineralized material in the graft was detected by radiography only on day 21. Morphologic and morphometric analysis of the histological sections showed that: a) the matrix remained intact up to day 7, followed by resorption of 16% by fibroblast-like mononuclear cells up to day 28; b) cartilage tissue was first detected on day 14 at the highest quantity observed in the experiment, occupying 5% of the graft volume and containing 4 x 102 chondrocytes/mm3 graft, followed by a substantial decline up to day 28 when it reached a volume density of 0.5% and 0.6 x 102 chondrocytes/mm3; c) bone cells and matrix were detected in minute amounts from day 14 on, with a volume density of 0.4% and containing 0.2 x 102 cells/mm3, which increased about 15 and 32 times, respectively, by the end of the 28-day, reaching 6% of the graft volume and 6 x 102 cells/mm3. We conclude that, despite the relatively low percentage of graft matrix resorption (total of 16%), the matrix was able to induce all events of the endochondral ossification cascade, i.e., formation and subsequent disappearance of hyaline cartilage, osteoblast differentiation, new bone formation and, later, the formation of hematogenous bone marrow.

In vitro cartilage tissue engineering using cancellous bone matrix gelatin as a biodegradable scaffold

In this study, we constructed tissue-engineered cartilage using allogeneic cancellous bone matrix gelatin (BMG) as a scaffold. Allogeneic BMG was prepared by sequential defatting, demineralization and denaturation. Isolated rabbit chondrocytes were seeded onto allogeneic cancellous BMG, and cell–BMG constructs were harvested after 1, 3 and 6 weeks for evaluation by hematoxylin and eosin staining for overall morphology, toluidine blue for extracellular matrix (ECM) proteoglycans, immunohistochemical staining for collagen type II and a transmission electron microscope for examining cellular microstructure on BMG. The prepared BMG was highly porous with mechanical strength adjustable by duration of demineralization and was easily trimmed for tissue repair. Cancellous BMG showed favorable porosity for cell habitation and metabolism material exchange with larger pore sizes (100–500 µm) than in cortical BMG (5–15 µm), allowing cell penetration. Cancellous BMG also showed good biocompatibility, which supported chondrocyte proliferation and sustained their differentiated phenotype in culture for up to 6 weeks. Rich and evenly distributed cartilage ECM proteoglycans and collagen type II were observed around chondrocytes on the surface and inside the pores throughout the cancellous BMG. Considering the large supply of banked bone allografts and relatively convenient preparation, our study suggests that allogeneic cancellous BMG is a promising scaffold for cartilage tissue engineering.

Bone regeneration mediated by biomimetic mineralization of a nanofiber matrix

Rapid bone regeneration within a three-dimensional defect without the use of bone grafts, exogenous growth factors, or cells remains a major challenge. We report here on the use of self-assembling peptide nanostructured gels to promote bone regeneration that have the capacity to mineralize in biomimetic fashion. The main molecular design was the use of phosphoserine residues in the sequence of a peptide amphiphile known to nucleate hydroxyapatite crystals on the surfaces of nanofibers. We tested the system in a rat femoral critical-size defect by placing pre-assembled nanofiber gels in a 5 mm gap and analyzed bone formation with micro-computed tomography and histology. We found within 4 weeks significantly higher bone formation relative to controls lacking phosphorylated residues and comparable bone formation to that observed in animals treated with a clinically used allogenic bone matrix.