Allograft Cellular Bone Matrix in Extreme Lateral Interbody Fusion: Preliminary Radiographic and Clinical Outcomes

Tohmeh, Antoine; Watson, Blake; Tohmeh, Mirna; Zielinski, Xavier J.

doi:10.1100/2012/263637

Cited by 74 publications

(55 citation statements)

References 52 publications

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“…A study of posterior spinal fusion in 41 patients using peri-operatively enriched autologous mesenchymal stem cells and a tricalcium phosphate matrix produced a 95% fusion rate (Gan, 2008). Cellular allograft bone matrix has also been used in a trial of 40 patients undergoing extreme lateral interbody fusion, and showed complete fusion in 90% of cases (Tohmeh, 2012). …”

Section: Introductionmentioning

confidence: 99%

Cell therapy for bone repair: narrowing the gap between vision and practice

Stegemann

Verrier²,

Gebhard

et al. 2014

eCM

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This position paper summarises a vision of how cell-based therapies can be applied clinically to regenerate bone, as well as the steps needed to narrow the gap between that vision and clinical reality. It is a result of the presentations and discussion of the "Cell Therapy for Bone Repair" breakout session at the AO Foundation Symposium "Where Science Meets Clinics" in Davos, Switzerland from September 5-7, 2013. Participants included leaders from science, medicine, and industry from around the world. The session included clinical and scientific presentations, as well as an extended discussion among participants. Bone tissue has an innate regenerative capacity that in most cases allows functional healing at damage sites. However, there are a number of serious conditions in which bone does not fully heal and the result is significant morbidity. The clinical need for new therapies is clear, and the breakout session participants were enthusiastic about the potential impact on cell-based therapies for bone repair in the clinic. However, they also recognised the significant challenges that face the development of commercially viable cell therapy products. This paper outlines a vision in which patient selection is based on expected therapeutic outcome to create a consistently successful, cost-effective, cell-based therapy for bone repair. The need for a more complete understanding of bone repair, a better infrastructure for preclinical studies, and the need for collaboration among stakeholders is discussed.

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Section: Introductionmentioning

confidence: 99%

Cell therapy for bone repair: narrowing the gap between vision and practice

Stegemann

Verrier²,

Gebhard

et al. 2014

eCM

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“…Ammerman et al [61] retrospectively reviewed 23 patients who underwent minimally invasive transforaminal lumbar interbody fusion with Osteocel Plus and found that at 12 months, 91.3% of the patients underwent successful fusion based on plain radiographs. Tohmeh et al [62] examined the 12-month clinical and radiographic outcomes of 40 patients who underwent an extreme lateral interbody fusion with Osteocel Plus and observed a 90.2% fusion rate using a combination of plain radiographs and computed tomography scans. Two of the published works did not disclose whether they had conflicts of interest [60,61] and one study was industry sponsored [62].…”

Section: Resultsmentioning

confidence: 99%

“…Tohmeh et al [62] examined the 12-month clinical and radiographic outcomes of 40 patients who underwent an extreme lateral interbody fusion with Osteocel Plus and observed a 90.2% fusion rate using a combination of plain radiographs and computed tomography scans. Two of the published works did not disclose whether they had conflicts of interest [60,61] and one study was industry sponsored [62]. Although the results reported in the aforementioned published works appear to be equivalent if not superior to the accepted rates of spinal fusion using iliac crest autograft, no such conclusion can be made without supportive evidence from large, randomized controlled trials.…”

Section: Resultsmentioning

confidence: 99%

Cellular bone matrices: viable stem cell-containing bone graft substitutes

et al. 2014

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BACKGROUND CONTEXT Advances in the field of stem cell technology have stimulated the development and increased use of allogenic bone grafts containing live mesenchymal stem cells (MSCs), also known as cellular bone matrices (CBMs). It is estimated that CBMs comprise greater than 17% of all bone grafts and bone graft substitutes used. PURPOSE To critically evaluate CBMs, specifically their technical specifications, existing published data supporting their use, US Food and Drug Administration (FDA) regulation, cost, potential pitfalls, and other aspects pertaining to their use. STUDY DESIGN Areview of literature. METHODS A series of Ovid, Medline, and Pubmed-National Library of Medicine/National Institutes of Health (www.ncbi.nlm.nih.gov) searches were performed. Only articles in English journals or published with English language translations were included. Level of evidence of the selected articles was assessed. Specific technical information on each CBM was obtained by direct communication from the companies marketing the individual products. RESULTS Five different CBMs are currently available for use in spinal fusion surgery. There is a wide variation between the products with regard to the average donor age at harvest, total cellular concentration, percentage of MSCs, shelf life, and cell viability after defrosting. Three retrospective studies evaluating CBMs and fusion have shown fusion rates ranging from 90.2% to 92.3%, and multiple industry-sponsored trials are underway. No independent studies evaluating spinal fusion rates with the use of CBMs exist. All the commercially available CBMs claim to meet the FDA criteria under Section 361, 21 CFR Part 1271, and are not undergoing FDA premarket review. The CBMs claim to provide viable MSCs and are offered at a premium cost. Numerous challenges exist in regard to MSCs’ survival, function, osteoblastic potential, and cytokine production once implanted into the intended host. CONCLUSIONS Cellular bone matrices may be a promising bone augmentation technology in spinal fusion surgery. Although CBMs appear to be safe for use as bone graft substitutes, their efficacy in spinal fusion surgery remains highly inconclusive. Large, nonindustry sponsored studies evaluating the efficacy of CBMs are required. Without results from such studies, surgeons must be made aware of the potential pitfalls of CBMs in spinal fusion surgery. With the currently available data, there is insufficient evidence to support the use of CBMs as bone graft substitutes in spinal fusion surgery.

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“…The study suggested that the use of Osteocel allograft is safe and effective in adult patients undergoing lumbar interbody spinal fusion procedure, while increased age and habitual smoking may delay fusion. Later, Tohmeh et al 70 reported that Osteocel plus had 90.2% complete interbody fusion in extreme lateral interbody fusion patients. In this study, 40 patients, ranging 36-82 years, were enrolled.…”

Section: Stem Cell With a Scaffold In Spine Fusionmentioning

confidence: 97%