The Bone Cell Advantage

ViviGen^® represents a paradigm shift in the field of bone repair. A body of evidence has emerged supporting the fact that bone cells are the preferred cells for bone formation compared to undifferentiated Mesenchymal Stem Cells (MSCs), because they are fully differentiated and are committed solely to laying down bone matrix.^2,3 Unlike MSCs, which require 2–4 weeks to differentiate into osteoblasts through the process of mesengenesis, ViviGen delivers lineage-committed osteogenic cells at the time of implantation.

Pre-Clinical Studies Suggest Bone Cells:^†

• Remain at the defect site longer², directly participate in the bone formation process, and deposit a higher quality of bone compared to MSCs.³
• Secrete chemotactic factors such as IGF-1, which may play a major role in recruitment of osteoblasts during bone formation.^4,5
• Secrete cytokines to stimulate angiogenesis⁴ and work in concert to facilitate further MSC differentiation.⁶
• Maintain viability, proliferation potential and osteoblastic function later in life compared to an MSC. ^7,8,9,10

Craniomaxillofacial

Segmental Cleft-orthognathic Surgery to Achieve Facial Balance, Fistula Closure, and Arch Unification. Parsaei Y, Maniskas S, Reategui A, Lopez J, Steinbacher D. Plast Reconstr Surg Glob Open. 2022 Jan 21;10(1):e3948. doi: 10.1097/GOX.0000000000003948. 

Managing Bilateral Oro-Sino-Orbital Fistulae in the Setting of Bilateral Tessier IV Clefts. Pontell, M. E., Barahimi, B., & Golinko, M. S. (2022). . Journal of Craniofacial Surgery, 33(1), e73-e76. https://doi.org/10.1097/SCS.0000000000008011

Characterization of an advanced viable bone allograft with preserved native bone-forming cells. Gianulis, E., Wetzell, B., Scheunemann, D. et al. Cell Tissue Bank (2022). https://doi.org/10.1007/s10561-022-10044-2 

A comprehensive series of in vitro and in vivo assays demonstrating that LifeNet Health’s viable bone allograft, ViviGen, provides all three essential bone remodeling properties and contains viable, lineage-committed bone-forming cells that do not elicit an immune response. Together, the results support ViviGen as a safe and effective alternative to autograft, without the associated drawbacks.

Immediate Reconstruction of Segmental Mandibular Defects With Nonvascular Bone Grafts: A 30-Year Perspective. Marschall JS, Kushner GM, Flint RL, Jones LC, Alpert B. Oral Maxillofac Surg. 2020 Nov;78(11):2099.e1-2099.e9. doi: 10.1016/j.joms.2020.03.035

In this review of 30 years of experience, the surgeons describe challenges and strategies for treating large segmental defects of the mandible. Notably, the surgeons state that they have stopped using Infuse due to cost and excessive facial swelling. They also report 2 successful cases using ViviGen in conjunction with autograft for defects averaging 7.4cm.
Article in Review

Treatment of Mandibular Non-union Using Patient Specific Crib Cage Plates and Cellular Bone Allograft: A Case Report. Ryu B, Abraham C, Polido WD. Craniomaxillofacial Trauma & Reconstruction Open. January 2021. doi:10.1177/24727512211005949

In this case study, the authors describe the use of Vivigen in combination with customized cribs for mandibular reconstruction after three self-inflicted gunshots to the face of a 72-year-old man. The multiple gunshots caused challenging comminuted fractures. Seven months after surgery, the combination of Vivigen and the custom cribs restored the patient’s ability to chew without pain or infection despite the severity of the injuries and advanced age.

Immediate Mandibular Reconstruction Using a Cellular Bone Allograft Following Tumor Resection in a Pediatric Patient. Alfi DM, Hassan A, East SM, Gianulis EC. FACE. 2021;2(4):490-495. doi:10.1177/27325016211057287  Article in Review

Extremities

Characterization of an advanced viable bone allograft with preserved native bone-forming cells. Gianulis, E., Wetzell, B., Scheunemann, D. et al. Cell Tissue Bank (2022). https://doi.org/10.1007/s10561-022-10044-2 

A comprehensive series of in vitro and in vivo assays demonstrating that LifeNet Health’s viable bone allograft, ViviGen, provides all three essential bone remodeling properties and contains viable, lineage-committed bone-forming cells that do not elicit an immune response. Together, the results support ViviGen as a safe and effective alternative to autograft, without the associated drawbacks.

A Retrospective Analysis of Outcomes from Foot and Ankle Arthrodesis and Open Reduction and Internal Fixation using Cellular Bone Graft Augmentation.  Moran TE, Sequeria A, Park JS. Foot and Ankle Specialist. 2020. In press. doi: 10.1177/1938640020952301

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. Article in Review

A Retrospective Comparison of Clinical and Patient-Reported Outcomes in Foot and Ankle Arthrodesis Procedures Using Two Cellular Bone Allografts. Roukis TS, Wetzell B, McLean JB, Dorsch K, & Moore MA. Clin Res Foot Ankle. 2020;8:300. ISSN: 2329-910X CRFA

This comparative study demonstrates the supierority of ViviGen over traditional MSC-based cellular bone allograft Trinity. Despite cormorbidities, patients experienced greater rates of fusion and  higher rates of satisfaction in foot and ankle arthrodesis procedures with ViviGen. Article in Review

A New Approach to Ankle and Foot Arthrodesis Procedures Using a Living Cellular Bone Matrix: A Case Series Roukis TS & Samsell B.  Clinical Research on Foot and Ankle. 2018;6(3):274.  doi: 10.4172/2329-910X.1000274
While clinical guidance cannot be provided based on this small series, these outcomes do provide an informative view of a new approach to ankle and hind foot arthrodesis using V-CBM and support additional research with a larger sample group including multiple surgeons for additional foot and ankle surgical procedures. Article in Review 

Use of Living Cellular Bone Matrix for Treating a Failed Ankle Arthroplasty: An Abbreviated Technique and Case Study Roukis TS. Clinical Research on Foot and Ankle. 2018;6(4);282. doi: 10.4172/2329-910X.1000282

This detailed case study presents an outcome of using V-CBM to salvage a failed agility total ankle replacement with talar component subsidence and degenerative joint disease in the subtalar joint on the right ankle and hindfoot. V-CBM enabled a successful salvage of failed ankle arthroplasty that had been complicated by two failed previous failed replacement surgeries. Article in Review

Living Cryopreserved Bone Allograft as an Adjunct for Hindfoot Arthrodesis. Magnus MK, Iceman KL, Roukis TS. Clin Podiatr Med Surg. 2018;35(3):295. doi:10.1016/j.cpm.2018.02.002

This article focuses on the use of bone grafts in hindfoot arthrodesis procedures and the development of orthobiologics, specifically, cellular bone allografts (CBAs).

Spine

Characterization of an advanced viable bone allograft with preserved native bone-forming cells. Gianulis, E., Wetzell, B., Scheunemann, D. et al. Cell Tissue Bank (2022). https://doi.org/10.1007/s10561-022-10044-2 

A comprehensive series of in vitro and in vivo assays demonstrating that LifeNet Health’s viable bone allograft, ViviGen, provides all three essential bone remodeling properties and contains viable, lineage-committed bone-forming cells that do not elicit an immune response. Together, the results support ViviGen as a safe and effective alternative to autograft, without the associated drawbacks.

Lumbar spine fusion outcomes using a cellular bone allograft with lineage-committed bone-forming cells in 96 patients. Elgafy, H., Wetzell, B., Gillette, M. et al.  BMC Musculoskelet Disord 22, 699 (2021). https://doi.org/10.1186/s12891-021-04584-z

The authors concluded that use of ViviGen yielded consistently successful fusion and significant decreases in patient-reported disability and pain, despite patient comorbidities and lifestyle risk factors that are known to negatively affect such bony healing. Article in Review

A 24-month retrospective update: follow-up hospitalization charges and readmissions in US lumbar fusion surgeries using a cellular bone allograft (CBA) versus recombinant human bone morphogenetic protein-2 (rhBMP-2) Wetzell B, McLean JB, Dorsch K, Moore MA.  J Orthop Surg Res. 2021 Nov 18;16(1):680. doi: 10.1186/s13018-021-02829-0. PMID: 34794470; PMCID: PMC8600873. PubMed (nih.gov)

The authors conclude that use of ViviGen for lumbar fusion surgeries performed in the US is associated with substantially lower 24-month follow-up hospitalization charges versus Infuse, with both exhibiting similar rates of subsequent lumbar fusion procedures and potentially-relevant readmissions. Article in Review

A large database study of hospitalization charges and follow-up re-admissions in US lumbar fusion surgeries using a cellular bone allograft (CBA) versus recombinant human bone morphogenetic protein-2 (rhBMP-2). Wetzell B, McLean JB, Moore MA, Kondragunta V, Dorsch KA. J Orthop Surg Res. 2020; 15: 544. doi.org/10.1186/s13018-020-02078-7

The results of this study indicate that use of ViviGen for lumbar fusion surgeries performed in the US may result in substantially lower overall hospitalization charges versus rhBMP-2, with both exhibiting similar rates of 12-month re-admissions and subsequent lumbar fusion procedures.

Multilevel instrumented posterolateral lumbar spine fusion with an allogeneic cellular bone graft. Hall JF, McLean JB, Jones SM, Moore MA, Nicholson MD, Dorsch KA.  J Orthop Surg Res. 2019;14(1):372.  doi:10.1186/s13018-019-1424-2

The use of V-CBA combined with local autograft in multilevel IPLF resulted in successful fusions in 98.7% of patients. These results are particularly robust given the complex nature of many of these cases: 89 patients had 4 or more surgical levels, and many patients had multiple comorbidities. Article in Review

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

Corso KA, Etter K, Menzie AM, Bhattacharyya S, Pracyk JB. Value in Health. 2018;21:S106. (68-20-219)

This study provides initial real-world insights into the patient population and oneyear outcomes for patients who received ViviGen during PSF. Future research with
greater statistical power as well as direct comparative data will further ourunderstanding of the value of ViviGen CBM.

Management of major vascular injury during pedicle screw instrumentation of thoracolumbar spine.Mirza AK, Alvi MA, Naylor RM, et al. Clin Neurol Neurosurg. 2017;163:53-59. doi:10.1016/j.clineuro.2017.10.011

Vascular injury is a rare complication of spinal instrumentation. Presentation can vary from immediate hemorrhage to pseudoaneurysm formation. In the literature, surgical approach to repair has varied based on anatomy, acuity of diagnosis, infection, and available technology. In this manuscript, we aim to describe our institutional experience with vascular injuries in thoraco-lumbar spine surgery.

Use of Allogenic Mesenchymal Cellular Bone Matrix in Anterior and Posterior Cervical Spinal Fusion: A Case Series of 21 Patients. Divi SN, Mikhael MM. Asian Spine J. 2017;11(3):454-462.doi: 10.4184/asj.2017.11.3.454

Twenty-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.

Trauma

Characterization of an advanced viable bone allograft with preserved native bone-forming cells. Gianulis, E., Wetzell, B., Scheunemann, D. et al. Cell Tissue Bank (2022). https://doi.org/10.1007/s10561-022-10044-2 

A comprehensive series of in vitro and in vivo assays demonstrating that LifeNet Health’s viable bone allograft, ViviGen, provides all three essential bone remodeling properties and contains viable, lineage-committed bone-forming cells that do not elicit an immune response. Together, the results support ViviGen as a safe and effective alternative to autograft, without the associated drawbacks.

Management of twenty centimeter segmental bone defect of femoral shaft secondary to infected non-union of fracture using masquelet technique: A case report. Kubes K, Friedman A, Pyle C, Diaz G, Hargett D. Int J Surg Case Rep. 2021 Jul;84:106107. doi: 10.1016/j.ijscr.2021.106107. Epub 2021 Jun 10.

Clinical outcome and explant histology after using a cellular bone allograft in two-stage total hip arthroplasty. Shahrdar C, McLean J, Gianulis E, et al. J Orthop Surg Res. 2020;15(1):16. doi:10.1186/s13018-020-1542-x Article in Review

These results suggest that V-CBA may facilitate new bone formation in healthy as well as in metabolically challenged patients.

Prosthesis-engaging retrograde femoral nail with locking plate for the treatment of a Vancouver B1 periprosthetic femur fracture nonunion: a case report. B. A., Harold, R. E., & Williams, J. (2019).  JBJS case connector, 9(4), e0108. DOI: 10.2106/JBJS.CC.19.00108

^†Pre-clinical data may not be predictive of human clinical results