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Research & References

SWSS Published Articles

It is now well recognized that the natural course of cervical radiculopathy is generally favorable. Comprehensive, aggressive, nonsurgical management often is successful with respect to functional outcomes, pain reduction, and patient satisfaction. Surgery is avoidable for most patients. The focus of this article is a review of the most recent and classic literature related to the nonsurgical management of cervical radiculopathies.

Low back pain with resultant loss of function, decreased productivity, and high economic costs is burdensome for both the individual and the society. Evidence suggests that intervertebral disc pathology is a major contributor to spine-related pain and degeneration. When commonly used conservative therapies fail, traditional percutaneous or surgical options may be beneficial for pain relief but are suboptimal because of their inability to alter disc microenvironment catabolism, restore disc tissue, and/or preserve native spine biomechanics. Percutaneously injected Multipotent Mesenchymal Stem Cell (MSC) therapy has recently gained clinical interest for its potential to revolutionarily treat disc-generated (discogenic) pain and associated disc degeneration. Unlike previous therapies to date, MSCs may uniquely offer the ability to improve discogenic pain and provide more sustained improvement by reducing disc microenvironment catabolism and regenerating disc tissue. Consistent treatment success has the potential to create a paradigm shift with regards to the treatment of discogenic pain and disc degeneration.

Summary: A one year retrospective study evaluating the effectiveness of intradiscal concentrated bone marrow aspirate in patients with back pain secondary to discogenic low back pain found that it was safe therapy as no patient was worse. Also patients with significant pain had improvement in pain and function in three months. This benefit was sustained at the one year mark.

Study details:

  • Mean improvement in commonly used outcome measures
  • No patient was worse, so it is safe procedure
  • Visual analog scale (VAS) reduced from 5.3 to 3.9 at one year. This represents a significant reduction on the patients perceived pain scale.
  • SF-36 increased from 54.4 and to 68.9 at one year. This represents an increase in perceived quality of life. 
  • ODI went from preoperative average of  35.5 to 23.7 at one year. This represents a reduction in sense of disability. 
  • Patients who had a pain level of ≤5 at baseline showed 40% improvement at three months and 33% at one year.
  • Patients who had a pain level of > 5 at baseline displayed 62% improvement at three months and 38% at one year.

Conclusion: Intradiscal injections of concentrated autologous bone marrow aspirate the potential to reduce pain and increase overall patient health. Study also found that those patients with higher pain initially had the best outcomes, most likely because they had the greatest room for improvement. 

Medical Journal Articles

A recent pilot study in 26 patients with moderate to severe discogenic low back pain has demonstrated that an injection of mesenchymal stem cells (bone-marrow derived) into an injured or degenerated disc can effectively reduce pain and improve function. Authors found that pain scores (VAS) decreased from 79.3 at baseline to 33.2 at 12 months postinjection. Similarly, functional scoring (ODI) improved from 56.5 at baseline to 25.0 after 12 months. The study also provides evidence that mesenchymal stem cells may be able to slow or reverse degeneration of the disc as 8 of 20 patients showed improved disc signal on MRI after one year. 

In the past decade, an increasing urge to develop new and novel methods for the treatment of degenerative diseases where there is currently no effective therapy has lead to the emerging of the cell therapy or cellular therapeutics approach for the management of those conditions where organ functions are restored through transplantation of healthy and functional cells. Stem cells, because of their nature, are currently considered among the most suitable cell types for cell therapy. There are an increasing number of studies that have tested the stromal stem cell functionality both in vitro and in vivo. Consequently, stromal (mesenchymal) stem cells (MSCs) are being introduced into many clinical trials due to their ease of isolation and efficacy in treating a number of disease conditions in animal preclinical disease models. The aim of this review is to revise MSC biology, their potential translation in therapy, and the challenges facing their adaptation in clinical practice.

Intervertebral disc degeneration (IDD) is a chronic, complex process associated with low back pain; mechanisms of its occurrence have not yet been fully elucidated. Its process is not only accompanied by morphological changes, but also by systematic changes in its histological and biochemical properties. Many cellular and molecular mechanisms have been reported to be related with IDD and to reverse degenerative trends, abnormal conditions of the living cells and altered cell phenotypes would need to be restored. Promising biological therapeutic strategies still rely on injection of active substances, gene therapy and cell transplantation. With advanced study of tissue engineering protocols based on cell therapy, combined use of seeding cells, bio-active substances and bio-compatible materials, are promising for IDD regeneration. Recently reported progenitor cells within discs themselves also hold prospects for future IDD studies. This article describes the background of IDD, current understanding and implications of potential therapeutic strategies.

Purpose There is increasing interest in the development of cell therapy as a possible approach for the treatment of degenerative disc disease. To regenerate nucleus pulposus tissue, the cells must produce an appropriate proteoglycan-rich matrix, as this is essential for the functioning of the intervertebral disc. The natural environment within the disc is very challenging to implanted cells, particularly if they have been subcultured in normal laboratory conditions. The purpose of this work is to discuss parameters relevant to translating different proposed cell therapies of IVD into clinical use. Results Several sources of cells have been proposed, including nucleus pulposus cells, chondrocytes and mesenchymal stem cells derived from bone marrow or adipose tissue. There are some clinical trials and reports of attempts to regenerate nucleus pulposus utilising either autologous or allogenic cells. While the published results of clinical applications of these cell therapies do not indicate any safety issues, additional evidence will be needed to prove their long-term efficacy. Conclusion This article discusses parameters relevant for successful translation of research on different cell sources into clinically applicable cell therapies: the influence of the intervertebral disc microenvironment on the cell phenotype, issues associated with cell culture and technical preparation of cell products, as well as discussing current regulatory requirements. There are advantages and disadvantages of each proposed cell type, but no strong evidence to favour any one particular cell source at the moment.

Disc cell therapies, in which cells are injected into the degenerate disc in order to regenerate the matrix and restore function, appear to be an attractive, minimally invasive method of treatment. Interest in this area has stimulated research into disc cell biology in particular. However, other important issues, some of which are discussed here, need to be considered if cell-based therapies are to be brought to the clinic. Purpose Firstly, a question which is barely addressed in the literature, is how to identify patients with ‘degenerative disc disease’ who would benefit from cell therapy. Pain not disc degeneration is the symptom which drives patients to the clinic. Even though there are associations between back pain and disc degeneration, many people with even severely degenerate discs, with herniated discs or with spinal stenosis, are pain-free. It is not possible using currently available techniques to identify whether disc repair or regeneration would remove symptoms or prevent symptoms from occurring in future. Moreover, the repair process in human discs is very slow (years) because of the low cell density which can be supported nutritionally even in healthy human discs. If repair is necessary for relief of symptoms, questions regarding quality of life and rehabilitation during this long process need consideration. Also, some serious technical issues remain. Finding appropriate cell sources and scaffolds have received most attention, but these are not the only issues determining the feasibility of the procedure. There are questions regarding the safety of implanting cells by injection through the annulus whether the nutrient supply to the disc is sufficient to support implanted cells and whether, if cells are able to survive, conditions in a degenerate human disc will allow them to repair the damaged tissue. Conclusions If cell therapy for treatment of disc-related disorders is to enter the clinic as a routine treatment, investigations must examine the questions related to patient selection and the feasibility of achieving the desired repair in an acceptable time frame. Few diagnostic tests that examine whether cell therapies are likely to succeed are available at present, but definite exclusion criteria would be evidence of major disc fissures, or disturbance of nutrient pathways as measured by post-contrast MRI.

Intervertebral disc (IVD) degeneration has been described as an aberrant, cell-mediated, age- and genetics-dependent molecular degeneration process, which can be accelerated by nutritional, mechanical and toxic factors. Collective involvement of these factors can result in structural failures, which are often associated with pain. Current treatment approaches are restricted to symptomatic therapies, not addressing options of restoring structural or biological deterioration of the IVD as the underlying problem. Therapeutic potentials of IVD cell transplantation, biomaterials, inhibiting or activating bioactive factors, including gene-therapeutic approaches, have been shown in vitro or in small animal models. Since human degenerative IVD cells display distinctive features with regard to cell biology and regenerative potential, we attempted a systematic review, investigating the in vitro response of human nucleus pulposus cells to different stimuli. Therefore, we conducted an electronic database search on Medline through July 2011 to identify, compare and discuss publications concerning the effects of cell–cell stimulation, bioactive factors, biomaterials and combinations thereof in terms of cell isolation, proliferation, differentiation and matrix protein synthesis. This survey and discussion might serve as a source for designing future biological treatment strategies for the human IVD. Copyright © 2012 John Wiley & Sons, Ltd.

Summary: A one year prospective study that demonstrated significant improvement in pain (58%) and function one year after patients with chronic low back pain secondary to degenerative disc disease that were treated with autologous stem cell in one or two lumbar discs. 21/26 patients had significant improvement and only 2/26 went on to have surgery. MRI after one year also showed rehydration of the disc, which represents improved disc health.

Study details:

  • Prospective, nonrandomized open pilot study of 26 patients
  • Studied to see if an intradiscal injection of concentrated Bone Marrow Aspirate (cBMA) reduced lumbar discogenic low back pain
  • Studied patients with a history of chronic low back pain, pain with activity for >6 months, MRI evidence of degenerative disc disease (discogram confirmation of low back pain in only 4/13 in each group), and who underwent intradiscal cBMA injections on a single occasion (13 had one level treated and 13 had two levels treated)
  • Measured visual analog scale (VAS) and oswestry disability index (ODI) at baseline (prestudy) then at 3, 6, and 12 months. MRI comparison prestudy and one year post study.

Conclusion: Study found improvement in all patients post injection; 63% pain reduction from baseline to 3 months (VAS reduced from 79.3 to 29.2) and 58% pain reduction at 12 months as well as improved function -ODI (56.2 reduced to 52). 21 out of 26 had significant improvement at 12 months. Only two out of 26 went on to have surgery by 12 months. MRI at one year follow up demonstrated improvement visualized as increased hydration of the disc. MRI = modified pfirrmann score of 4-7, modic changes = grade 2, disc height < 30% reduced. Found MAC critical dose =2000 MCS/ml (> 2,600 cfu/ml = increased improvement by 3 months and sustained at 6 month)

Low back pain, strongly associated with intervertebral disc (IVD) degeneration, affects a large proportion of the population and has major social and economic costs. Current treatments remain inadequate, targeting the symptoms without addressing the underlying cause. As such, efforts are being directed towards the development of therapies aimed at alleviating pain through the restoration of IVD function. The potential of cell-based therapies for the treatment of IVD degeneration are being actively explored, with an emphasis on cell/biomaterial tissue engineering. Adult mesenchymal stem cells, capable of differentiating down the discogenic lineage, have shown promise as a suitable cell source for IVD tissue engineering. However, a number of factors, (discussed in this review), remain to be addressed, including development of a differentiation protocol to produce the correct cell phenotype, identification of suitable biomaterials for cell delivery/implantation, and ensuring cell survival and correct function upon implantation into the degenerate IVD.

Low back pain (LBP) is one of the most common painful conditions that lead to work absenteeism, medical visits, and hospitalization. The majority of cases showing signs of LBP are due to age-related degenerative changes in the intervertebral disk (IVD), which are, in fact, associated with multiple spine pathologies. Traditional and more conservative procedures/clinical approaches only treat the symptoms of disease and not the underlying pathology, thus limiting their long-term efficiency. In the last few years, research and development of new approaches aiming to substitute the nucleus pulposus and annulus fibrosus tissue and stimulate its regeneration has been conducted. Regeneration of the damaged IVD using tissue engineering strategies appears particularly promising in pre-clinical studies. Meanwhile, surgical techniques must be adapted to this new approach in order to be as minimally invasive as possible, reducing recovering time and side effects associated to traditional surgeries. In this review, the current knowledge on IVD, its associated pathologies and current surgical procedures are summarized. Furthermore, it also provides a succinct and up-to-date overview on regenerative medicine research, especially on the newest tissue engineering strategies for IVD regeneration.

Summary: A prospective study of ten patients with low back pain secondary to degenerative disc disease. These patients had low back pain and MRI evidence of degenerative disc disease. One year after treatment with autologous expanded bone marrow that was injected into the disc, subjects showed significant improvement with reduced low back pain and improved quality of life.  MRI also showed rehydration of the disc after one year, which represents improved disc health.

Study details:

  • Prospective, nonrandomized study of ten patients.
  • Studied patients with low back pain secondary to degenerative disc disease and MRI evidence of degenerative disc disease (DDD)
  • Patients treated with autologous expanded bone marrow injected into the nucleus of the disc
  • Patients followed for one year and evaluated for improvement in quality of life and low back pain via visual analog scale (vas), disability via the Oswestry Disability Index (odi) and SF-36, and MRI follow up for any interval changes

Conclusion: Study found improvement in both pain and disability. Nine out of ten patients improved with 85% improvement reported in the first three months. In addition to improvement in pain and function, there was observable radiologic improvement seen on MRI. Follow up MRI at one year also found evidence of improved disc health evidenced by increased fluid content in the disc (reduced dehydration). This represents a reversal of disc degeneration from a radiological standpoint.

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Summary: A one year prospective, double-blind, randomized control study that was designed to determine whether single injections of autologous platelet rich plasma (PRP) into symptomatic degenerative intervertebral discs would improve participant reported pain and function. The results indicate participants that received intradiscal PRP showed significant improvements in Functional Rating Index, pain scale, and patient satisfaction scores over 8 weeks compared to control subjects. These results were maintained at the one year mark. 
Study details: 

Population: Adults with chronic (> 6 months) moderate-to-severe lumbar discogenic pain that were unresponsive to conservative treatment (oral medications, rehabilitation therapy, and/or injection therapy)
Baseline information obtained from each participant before intervention via Functional Rating Index (FRI), Numeric Rating Scale (NRS), and 36 item Short Form Health Survey questionnaires

Intervention: a covered syringe containing 3-4 ml of PRP (treatment group) was injected under fluoroscopic guidance into the mid-portion of the suspected disk levels. Only disk levels that elicited concordant pain with evidence of incomplete annular disruption were injected. 

Comparison: contrast agent (control group) was injected under fluoroscopic guidance into the mid-portion of the suspected disk levels. Only disk levels that elicited concordant pain with evidence of incomplete annular disruption were injected. 
Follow up questionnaires were administered at 1 week, 4 weeks, 8 weeks, 6 months, and 12 months or more post-injection.

Conclusion: Among the PRP group, 56% of the participants were satisfied with or would undergo the same treatment compared with 18% of the control participants. Longitudinal analysis showed statistically significant improvements from baseline to 6 months were observed NRS worst pain (1.66 point change) (P<.01), FRI (12.92 point change) (P<.01), and Short Form Health Survey (14.67 point change) (P=.03). From baseline to one year statistically significant improvements included NRS worst pain (2.12 point change) (P<.01), FRI (17.49 point change) (P<.01), and Short Form Health Survey (16.80 point change) (P<.01). No participant in the treatment group experienced complications. 

Clinical Studies

Disclosures: This study was sponsored by Spinal Restoration, Inc. Drs. Yin, Pauza, and Olan are members of the Clinical Advisory Board and have been granted options, own stock or receive consulting fees from Spinal Restoration. Jeff Doerzbacher is Director of Regulatory and Clinical Affairs, and Dr. Thorne is Director of Scientific Affairs for the sponsor.

Abstract

Objective

Assess the safety and efficacy of intradiscal fibrin sealant in adults with chronic discogenic low back pain.

Design

Prospective, nonrandomized Food and Drug Administration approved pilot study.

Setting

Three centers in the United States.

Subjects

Fifteen adults with chronic, single, or contiguous two‐level lumbar discogenic pain confirmed through meticulous provocation discography.

Interventions

Volume‐ and pressure‐controlled intradiscal delivery of BIOSTAT BIOLOGX® Fibrin Sealant with the Biostat® Delivery Device into symptomatic lumbar disc(s).

Outcome Measures

Assessments were performed at baseline, 72 hours, and 1, 4, 13, 26, 52, and 104 weeks following intervention. Potential adverse events were evaluated with serial assessment of neurological status, radiographic, and magnetic resonance imaging (MRI). Efficacy measures included serial assessments of low back pain visual analog scale (VAS) measurements and the Roland‐Morris Disability Questionnaire (RMDQ).

Results

Safety neurological assessments, X‐ray, and MRI showed no significant changes. Adverse events were reported in nine subjects. Two instances of low back muscle spasm and one case of discitis were the only events considered related to the procedure or product.

Efficacy

Mean low back pain VAS scores (mm) decreased from 72.4 (95% confidence interval 64.6–80.3) at baseline to 31.7 (17.4–46.1), 35.4 (17.7–53.1), and 33.0 (16.3–49.6); mean RMDQ score improved from 15.2 (12.7–17.7) at baseline to 8.9 (5.3–12.5), 6.2 (3.4–9.1), and 5.6 (2.9‐8.4) at 26, 52, and 104 weeks, respectively.

Conclusion

Intradiscal injection of BIOSTAT BIOLOGX Fibrin Sealant with the Biostat Delivery Device appears safe and may improve pain and function in selected patients with discogenic pain.

 

Publications

Abstract

Background context

Intradiscal electrothermal therapy (IDET) is a treatment for discogenic low back pain the efficacy of which has not been rigorously tested.

Purpose

To compare the efficacy of IDET with that of a placebo treatment.

Study design/setting

Randomized, placebo-controlled, prospective trial.

Patient sample

Patients were recruited by referral and the media. No inducements were provided to any patient in order to have them participate. Of 1,360 individuals who were prepared to submit to randomization, 260 were found potentially eligible after clinical examination and 64 became eligible after discography. All had discogenic low back pain lasting longer than 6 months, with no comorbidity. Thirty-seven were allocated to IDET and 27 to sham treatment. Both groups were satisfactorily matched for demographic and clinical features.

Methods

IDET was performed using a standard protocol, in which the posterior annulus of the painful disc was heated to 90 C. Sham therapy consisted of introducing a needle onto the disc and exposing the patient to the same visual and auditory environment as for a real procedure. Thirty-two (85%) of the patients randomized to the IDET group and 24 (89%) of those assigned to the sham group complied fully with the protocol of the study, and complete follow-up data are available for all of these patients.

Outcome measures

The principal outcome measures were pain and disability, assessed using a visual analog scale for pain, the Short Form (SF)-36, and the Oswestry disability scale.

Results

Patients in both groups exhibited improvements, but mean improvements in pain, disability and depression were significantly greater in the group treated with IDET. More patients deteriorated when subjected to sham treatment, whereas a greater proportion showed improvements in pain when treated with IDET. The number needed to treat, to achieve 75% relief of pain, was five. Whereas approximately 40% of the patients achieved greater than 50% relief of their pain, approximately 50% of the patients experienced no appreciable benefit.

Conclusions

Nonspecific factors associated with the procedure account for a proportion of the apparent efficacy of IDET, but its efficacy cannot be attributed wholly to a placebo effect. The results of this trial cannot be generalized to patients who do not fit the strict inclusion criteria of this study, but IDET appears to provide worthwhile relief in a small proportion of strictly defined patients undergoing this treatment for intractable low back pain.

 

Abstract

Background context

In a small prospective study assessing 10 symptomatic and 10 asymptomatic subjects, Schellhas et al. compared cervical discography to magnetic resonance imaging. Within that study he reported on the distribution of pain for the C3–C4 to C6–C7 levels. Four years later, Grubb and Ellis reported retrospective data from his 12-year experience using cervical discography from C2–C3 to C7–T1 in 173 patients. To date, no large prospective study defining pain referral patterns for each cervical disc has been performed.

Purpose

To conduct a prospective visual and statistical descriptive study of pain provocation of a cohort of subjects undergoing cervical discography.

Study design/setting

Prospective multicenter descriptive study.

Methods

Pain referral maps were generated for each disc level from patients undergoing cervical discography with at least two levels assessed. If concordant pain was reproduced in a morphologically abnormal disc, the subject immediately completed a pain diagram. An independent observer interviewed the subject and recorded the location of provoked symptoms. Visual data were compiled using a body sector bit map, which consisted of 48 clinically relevant body regions. Visual maps with graduated color codes and frequencies of symptom location at each cervical disc level were generated.

Results

A total of 101 symptom provocation maps were recorded during cervical discography on 41 subjects. There were10 at C2–C3, 19 at C3–C4, 27 at C4–C5, 27 at C5–C6, 16 at C6–C7 and 2 at C7–T1. Predominantly unilateral symptoms were provoked just as often as bilateral symptoms. The C2–C3 disc referred pain to the neck, subocciput and face. The C3–C4 disc referred pain to the neck, subocciput, trapezius, anterior neck, face, shoulder, interscapular and limb. The C4–C5 disc referred pain to the neck, shoulder, interscapular, trapezius, extremity, face, chest and subocciput. The C5–C6 disc referred pain to the neck, trapezius, interscapular, suboccipital, anterior neck, chest and face. The C6–C7 disc referred pain to the neck, interscapular, trapezius, shoulder, extremity and subocciput. At C7–T1 we produced neck and interscapular pain. Visual maps with graduated color codes and frequencies of symptom location at each cervical disc level were generated.

Conclusions

In conclusion, these results confirm the observations of prior investigators that cervical internal disc disruption can elicit axial and peripheral symptoms. The particular patterns of pain generation allow the discographer to preprocedurally anticipate disc levels to assess. With these data, the number of disc punctures that are required can be limited rather than routinely assessing all cervical discs.

 

Abstract

Purpose

To evaluate relationships among ROM and self-reported clinical outcomes ins ingle or multilevel ProDisc-L patients.

Study Design/Setting

USE-FDA IDE trial, one site

Patient Sample

Randomized (RCT, n-59), Pilot (P, n=6), Continued Access (CA, n=147) and Compassionate Use (CU, n=37).

Outcome Measure

Oswestry Disability Index (ODI), Visual Analogue Scale for pain (VAS).

Conclusions

ROM was maintained throughout follow-up in Pro-Disc-L, patients. Importantly, greater ROM was strongly associated with greater functional ability, less pain, and greater satisfaction. This is the first report of these associations.

Abstract

Study Design:

This prospective study evaluated the diagnostic utility of historically accepted sacroiliac joint tests. A multidisciplinary expert panel recommended 12 of the "best" sacroiliac joint tests to be evaluated against a criterion standard of unequivocal gain relief after an intra-articular injection of local anesthetic into the sacroiliac joint.

Objective:

To identify a single sacroiliac joint test or ensemble of test that are sufficiently useful in diagnosing sacroiliac joint disorders to be clinically valuable.

Summary of Background Data:

No previous research has been done to evaluate any physical test of sacroiliac joint pain against an accepted criterion standard.

Method:

Historical data was obtained, and the 12 tests were performed by two examiners on 85 patients who subsequently underwent sacroiliac joint blocks. Ninety percent or more relief was considered a positive response, and less then 90% relief was considered a negative response.

Results:

There were 45 positive and 40 negative responses. No historical feature, none of the 12 sacroiliac joint tests, and no ensemble of these 12 tests demonstrated worthwhile diagnostic value.

Conclusion:

Sacroiliac joint pain is resistant to identification by the historical and physical examination data from tests evaluated in this study.

The surfaces of annulus fibrosus tears are known harbingers of inflammatory constituents within intervertebral discs, stimulating sensitized nocioceptors within those tears. Other current treatment options of internal disc disruption neglect to specifically address the surface of these tears. Therefore, this investigation answers the question: does nonautologous fibrin sealant applied to the surface of annulus fibrosus tears mechanically glue and seal annular tears? Regarding this query, results suggest nonautologous concentrated fibrin successfully seals annulus fibrosus tears with a “suture-like mechanical sealant,” serving as a safe option for treating symptomatic or nonsymptomatic intervertebral disc tears. Sealing tears prevents pain-generating chemicals of the nucleus pulposus from leaking through annular tears. More specifically, fibrin sealant minimizes or eliminates extravasation of nucleus pulposus through tears and voids within the annulus fibrosus. Moreover, an investigation subjecting discs to an “internal pressure challenge” objectively affirms fibrin's ability to seal torn and degenerated discs against a pressure challenge. (1 psi ¼ 6.89476 kPs (disc mean pressure pretreatment ¼ 75.84 kPs; post-treatment ¼ 179.3 kPs: (n ¼ 347, P o 0.001). Therefore, sealing annular tears serves to minimize extravasation of nucleus pulposus through annular tears, thus potentially treating symptoms caused by internal disc disruption, “Leaky Disc Syndrome,” and chemical radiculopathy. Additionally, sealing annular tears potentially allows adjunctive regenerative biologics such as mesenchymal precursor cells, platelet rich plasma, and growth factors to remain within discs, thus, potentially optimizing their efficacy. A prior in vivo investigation demonstrated the vast majority of mesenchymal stem cells leaked from animal intravertebral discs, and another demonstrated radiolabeled mesenchymal stem cells leaked from degenerated discs and were subsequently found within new exuberant osteophytes adjacent to the degenerated disc. Intra-annular nonautologous concentrated fibrin shares a benefit of other intradiscal biologics in that fibrin does not cause aberrant detrimental mechanical forces on adjacent discs, compared with surgical fusion and disc arthrodesis, which both cause aberrant, potentially damaging mechanical forces on adjacent segments. The mean number of morphologically abnormal lumbar intervertebral discs in this population with chronic low back pain was 3.21 discs

System for Repairing Inter-Vertebal Discs

Patent number: 6428576
Abstract: A method of repairing a defect in an annulus fibrosus of an intervertebral disc, without excising the entire nucleus pulposus of the disc with an in situ curable, bio-compatible polymerizable or polymeric material, wherein at least one of said components is a cross linkable material and at least one other of said components is a cross linking agent for said cross linkable material.
Inventor: Kevin Pauza

Biological Bioadhesive Composition and Methods of Preparation and Use

Patent number: 6468527
Abstract: A biologic preparation (tissue adhesive) comprising fibrinogen, thrombin and a corticosteroid agent, wherein a solution containing the corticosteroid treatment agent is used to reconstitute the thrombin from a freeze-dried state.
Inventor: Kevin Pauza

Biological Bioadhesive Composition and Methods of Preparation and Use

Patent Number: 6921532
Absract: A biologic preparation (tissue adhesive) for injection into a human body comprising fibrinogen, thrombin and a corticosteroid agent.
Inventor: Kevin Pauza

Biological Bioadhesive Composition and Methods of Preparation and Use

Patent Number: 7229633
a. A method for delivering a biological tissue adhesive for injection in a human body comprising fibrinogen, thrombin and a corticosteroid agent.

b. A method for delivering a biological tissue adhesive for injection in a human body comprising: providing a spinal needle, a dual syringe, a freeze-dried fibrinogen component, a freeze-dried thrombin component, and a betamethasone-containing solution to form a system for delivering a biological tissue adhesive.
Inventor: Kevin Pauza

Biological Bioadhesive Composition and Methods of Preparation and Use

Patent Number: 7235255
a. A system for delivering a biological tissue adhesive, comprising: a fibrinogen component; a thrombin component, and a corticosteroid-containing solution.
b. A system for delivering a biological tissue adhesive, comprising: a fibrinogen component; a thrombin component, and a corticosteroid-containing solution, a spinal needle; and a dual syringe.
Inventor: Kevin Pauza

Injection of Fibrin Sealant Including an Anesthetic in Spinal Applications

Patent number: 7597687
Abstract: A method of treating a disc that is leaking nucleus pulposus through at least one defect in the annulus fibrosus. The method includes injecting a fibrin sealant into the disc to reduce at least a portion of the at least one defect, wherein the fibrin sealant injected into the disc comprises an anesthetic, fibrinogen and an activating compound, wherein at least a portion of the fibrin forms after injection, with the proviso that a corticosteroid is absent from the fibrin sealant injected into the disc.
Type: Grant
Filed: August 17, 2005
Issued: October 6, 2009
Assignee: Spinal Restoration, Inc.
Inventors: Kevin Pauza, Brian D. Burkinshaw, Steven I. Whitlock, Mark I. Richards, James B. Rogan

Apparatus and Method for Delivery of Biologic Sealant

Patent Number: 8047407
a. A device for delivery of biologic materials, comprising a cartridge having at least two cylinder bores for fluids of the biologic materials to be delivered.

b. A kit for treating a disc, comprising: fibrinogen, thrombin, and a device for delivery of biologic materials.
Inventor: Kevin Pauza

Enhanced Biological Autologous Tissue Adhesive Composition and Methods of Preparation and Use

Patent Number: 8124075
a. The invention includes a method for treating a disc of a patient using a tissue sealant comprising a snake venom to convert the fibrinogen to fibrin and at least one supplement.
b. Supplements include a long "laundry list" of possible additives.
Inventor: Kevin Pauza

Injection of Fibrin Sealant Using Reconstituted Components in Spinal Applications

Patent number: 8206448
Abstract: A method of treating a disc that is leaking nucleus pulposus through at least one defect in the annulus fibrosus. The method includes injecting a fibrin sealant into the disc to reduce at least a portion of the at least one defect, wherein the fibrin sealant injected into the disc comprises fibrinogen and an activating compound, wherein at least a portion of the fibrin forms after injection, wherein the fibrinogen, the activating compound or both has been reconstituted with a solution containing at least one additive, with the proviso that a corticosteroid is absent from the fibrin sealant injected into the disc.
Type: Grant
Filed: August 17, 2005
Issued: June 26, 2012
Assignee: Spinal Restoration, Inc.
Inventors: Brian D. Burkinshaw, Steven I. Whitlock, Kevin Pauza, Mark I. Richards, James B. Rogan

Method for Repairing Intervertebral Discs

Patent Number: 835714

a. A method of repairing a defect in an annulus fibrosus of an intervertebral disc, without excising the entire nucleus pulposus of the disc, comprising: inserting an introducer needle having a tip through the annulus fibrosus, injecting an in situ curable, bio-compatible polymerizable or polymeric material composition that includes a cross-linking agent into the disc.

b. The method (above) further including a very long list of drugs, biologics and other additives.
Inventor: Kevin Pauza

Injection of Fibrin Sealant Including an Anesthetic in Spinal Applications

Patent number: 8394072
Abstract: A method of treating a disc that is leaking nucleus pulposus through at least one defect in the annulus fibrosus. The method includes injecting a fibrin sealant into the disc to reduce at least a portion of the at least one defect, wherein the fibrin sealant injected into the disc comprises an anesthetic, fibrinogen and an activating compound, wherein at least a portion of the fibrin forms after injection, with the proviso that a corticosteroid is absent from the fibrin sealant injected into the disc.
Type: Grant
Filed: October 5, 2009
Issued: March 12, 2013
Assignee: Spinal Restoration, Inc.
Inventors: Kevin Pauza, Brian D. Burkinshaw, Steven I. Whitlock, Mark I. Richards, James B. Rogan

Injection of Fibrin Sealant Including an Anesthetic in Spinal Applications

Patent number: 8403895
Abstract: A method of treating a disc that is leaking nucleus pulposus through at least one defect in the annulus fibrosus. The method includes injecting a fibrin sealant into the disc to reduce at least a portion of the at least one defect, wherein the fibrin sealant injected into the disc comprises an anesthetic, fibrinogen and an activating compound, wherein at least a portion of the fibrin forms after injection, with the proviso that a corticosteroid is absent from the fibrin sealant injected into the disc.
Type: Grant
Filed: October 5, 2009
Issued: March 26, 2013
Assignee: Spinal Restoration, Inc.
Inventors: Kevin Pauza, Brian D. Burkinshaw, Steven I. Whitlock, Mark I. Richards, James B. Rogan

Injection of Fibrin Sealant in the Absence of Corticosteroids in Spinal Applications

Patent number: 8403923
Abstract: A method and kit for treating a disc that is leaking nucleus pulposus through at least one defect in the annulus fibrosus. The method includes injecting a fibrin sealant into the disc to reduce at least a portion of the at least one defect, wherein the fibrin sealant injected into the disc comprises fibrinogen and an activating compound, wherein at least a portion of the fibrin forms after injection, with the proviso that a corticosteroid is absent from the fibrin sealant injected into the disc.
Type: Grant
Filed: August 17, 2005
Issued: March 26, 2013
Assignee: Spinal Restoration, Inc.
Inventors: Steven I. Whitlock, Brian D. Burkinshaw, Kevin Pauza

Apparatus and Method for Injection of Fibrin Sealant in Spinal Applications

Patent number: 8419722
Abstract: An apparatus for percutaneous delivery of a sealant comprising: at least two fluid reservoirs, an introducer needle having a distal tip that is in fluid communication with at least one reservoir, a fluid delivery tube that is in fluid communication with a second reservoir, wherein the fluid delivery tube has a tip and wherein the fluid delivery tube is configured so that the tip of the fluid delivery tube does not extend past the distal tip of the introducer needle during use.
Type: Grant
Filed: January 5, 2007
Issued: April 16, 2013
Assignee: Spinal Restoration, Inc.
Inventors: Mark Richards, Brian D. Burkinshaw, Kevin Pauza, James B. Rogan, John Wheeler

13/533,450 - Injection of Fibrin Sealant Using Reconstituted Components in Spinal Application

a. A method of treating a disc comprising injecting a fibrin sealant into the disc, wherein neither the nucleus pulposus nor the annulus fibrosus has been heated...and wherein the injecting occurs by inserting an introducer needle having a tip into an intra-discal space, inserting a second needle or a polymeric catheter through the introducer needle up to but not beyond the tip of the introducer needle, and injecting the fibrinogen through the introducer needle and injecting the activating compound through the second needle or polymeric catheter, or injecting the activating compound through the introducer needle and injecting the fibrinogen through the second needle or polymeric catheter.

b. The method (above) further including a very long list of drugs, biologics and other additives.

c. A method of treating a disc comprising injecting a fibrin sealant into the disc, wherein neither the nucleus pulposus nor the annulus fibrosus has been heated...and wherein the fibrin sealant does not include a corticosteroid, and wherein normal hydrostatic pressure in the disc is restored or normal disc height is restored or both.

d. The method (above) wherein the injecting occurs by inserting an introducer needle having a tip into the nucleus pulposus, inserting a second needle having a tip into the nucleus pulposus, and injecting the fibrinogen through the introducer needle and injecting the thrombin through the second needle, or injecting the thrombin through the introducer needle and injecting the fibrinogen through the second needle.
Inventor: Kevin Pauza

11/650306 - Fibrin Sealant Delivery Device Including Pressure Monitoring, and method and kits thereof

a. An apparatus for delivering a biocompatible sealant, comprising: at least two reservoirs for fluids to be delivered, an actuation assembly that causes the fluids to flow out of the reservoir through an exit port in the reservoir, and a pressure monitor coupled to the delivery device to measure pressure within the device.
Inventor: Kevin Pauza

Injection of Fibrin Sealant Using Reconstituted Components in Spinal Applications

Application number: 20120328600
Abstract: A method of treating a disc that is leaking nucleus pulposus through at least one defect in the annulus fibrosus. The method includes injecting a fibrin sealant into the disc to reduce at least a portion of the at least one defect, wherein the fibrin sealant injected into the disc comprises fibrinogen and an activating compound, wherein at least a portion of the fibrin forms after injection, wherein the fibrinogen, the activating compound or both has been reconstituted with a solution containing at least one additive, with the proviso that a corticosteroid is absent from the fibrin sealant injected into the disc.
Type: Application
Filed: June 26, 2012
Issued: December 27, 2012
Inventors: Brian D. Burkinshaw, Steven I. Whitlock, Kevin Pauza, Mark I. Richards, James B. Rogan

Injection of Fibrin Sealant in the Absence of Corticosteroids in Spinal Applications

Application number: 20110213464
Abstract: A method and kit for treating a disc that is leaking nucleus pulposus through at least one defect in the annulus fibrosus. The method includes injecting a fibrin sealant into the disc to reduce at least a portion of the at least one defect, wherein the fibrin sealant injected into the disc comprises fibrinogen and an activating compound, wherein at least a portion of the fibrin forms after injection, with the proviso that a corticosteroid is absent from the fibrin sealant injected into the disc.
Type: Application
Filed: October 22, 2010
Issued: September 1, 2011
Inventors: Steven I. Whitlock, Brian D. Burkinshaw, Kevin Pauza, John L. Wheeler, Kevin Thorne

Injection of Fibrin Sealant Using Reconstituted Components in Spinal Applications

Application number: 20120328600
Abstract: A method of treating a disc that is leaking nucleus pulposus through at least one defect in the annulus fibrosus. The method includes injecting a fibrin sealant into the disc to reduce at least a portion of the at least one defect, wherein the fibrin sealant injected into the disc comprises fibrinogen and an activating compound, wherein at least a portion of the fibrin forms after injection, wherein the fibrinogen, the activating compound or both has been reconstituted with a solution containing at least one additive, with the proviso that a corticosteroid is absent from the fibrin sealant injected into the disc.
Type: Application
Filed: June 26, 2012

Injection of Fibrin Sealant Including an Anesthetic in Spinal Applications

Application number: 20100233148
Abstract: A method of treating a disc that is leaking nucleus pulposus through at least one defect in the annulus fibrosus. The method includes injecting a fibrin sealant into the disc to reduce at least a portion of the at least one defect, wherein the fibrin sealant injected into the disc comprises an anesthetic, fibrinogen and an activating compound, wherein at least a portion of the fibrin forms after injection, with the proviso that a corticosteroid is absent from the fibrin sealant injected into the disc.
Type: Application
Filed: October 5, 2009
Issued: September 16, 2010
Inventors: Kevin Pauza, Brian D. Burkinshaw, Steven I. Whitlock, Mark I. Richards, James B. Rogan

Injection of Fibrin Sealant Including an Anesthetic in Spinal Applications

Application number: 20100143327
Abstract: A method of treating a disc that is leaking nucleus pulposus through at least one defect in the annulus fibrosus. The method includes injecting a fibrin sealant into the disc to reduce at least a portion of the at least one defect, wherein the fibrin sealant injected into the disc comprises an anesthetic, fibrinogen and an activating compound, wherein at least a portion of the fibrin forms after injection, with the proviso that a corticosteroid is absent from the fibrin sealant injected into the disc.
Type: Application
Filed: October 5, 2009
Issued: June 10, 2010
Inventors: Kevin Pauza, Brian D. Burkinshaw, Steven I. Whitlick, Mark I. Richards, James B. Rogan

Injection of Fibrin Sealant Including an Anesthetic in Spinal Applications

Application number: 20100137816
Abstract: A method of treating a disc that is leaking nucleus pulposus through at least one defect in the annulus fibrosus. The method includes injecting a fibrin sealant into the disc to reduce at least a portion of the at least one defect, wherein the fibrin sealant injected into the disc comprises an anesthetic, fibrinogen and an activating compound, wherein at least a portion of the fibrin forms after injection, with the proviso that a corticosteroid is absent from the fibrin sealant injected into the disc.
Type: Application
Filed: October 5, 2009
Issued: June 3, 2010
Inventors: Kevin Pauza, Brian D. Burkinshaw, Steven I. Whitlock, Mark I. Richards, James B. Rogan

Method For Treating Herniated Discs

Application number: 20080294261
Abstract: A method is effective for treating herniated discs. The method includes (a) surgically remove a herniated portion of disc annulus from a herniated disc, or surgically depressing and holding a herniated portion of disc annulus within original boundaries of the herniated disc, and (b) re-enforcing the surgically treated disc with an effective amount of a biocompatible degradable polymeric compound, such as a fibrin sealant.
Type: Application
Filed: May 24, 2007
Issued: November 27, 2008
Inventors: Kevin Pauza, Brian Burkinshaw, James Rogan

Fibrin Sealant Delivery Device Including Pressure Monitoring, and Method and Kits Thereof

Application number: 20070213660
Abstract: Apparatus for delivering biologic sealant device that includes a pressure monitor coupled to the delivery device to measure pressure within the device. A method of treating a disc using the device as well as a kit including the device is described.
Type: Application
Filed: January 5, 2007
Issued: September 13, 2007
Inventors: Mark Richards, Brian Burkinshaw, Kevin Pauza, James Rogan

Apparatus and Method for Injection of Fibrin Sealant in Spinal Applications

Application number: 20070191781
Abstract: An apparatus for percutaneous delivery of a sealant comprising: at least two fluid reservoirs, an introducer needle having a distal tip that is in fluid communication with at least one reservoir, a fluid delivery tube that is in fluid communication with a second reservoir, wherein the fluid delivery tube has a tip and wherein the fluid delivery tube is configured so that the tip of the fluid delivery tube does not extend past the distal tip of the introducer needle during use.
Type: Application
Filed: January 5, 2007
Issued: August 16, 2007
Inventors: Mark Richards, Brian Burkinshaw, Kevin Pauza, James Rogan, John Wheeler

Injection of Fibrin Sealant in the Absence of Corticosteroids in Spinal Applications

Application number: 20060106364
Abstract: A method and kit for treating a disc that is leaking nucleus pulposus through at least one defect in the annulus fibrosus. The method includes injecting a fibrin sealant into the disc to reduce at least a portion of the at least one defect, wherein the fibrin sealant injected into the disc comprises fibrinogen and an activating compound, wherein at least a portion of the fibrin forms after injection, with the proviso that a corticosteroid is absent from the fibrin sealant injected into the disc.
Type: Application
Filed: August 17, 2005
Issued: May 18, 2006
Inventors: Steven Whitlock, Brian Burkinshaw, Kevin Pauza

Injection of Fibrin Sealant Including an Anesthetic in Spinal Applications

Application number: 20060095016
Abstract: A method of treating a disc that is leaking nucleus pulposus through at least one defect in the annulus fibrosus. The method includes injecting a fibrin sealant into the disc to reduce at least a portion of the at least one defect, wherein the fibrin sealant injected into the disc comprises an anesthetic, fibrinogen and an activating compound, wherein at least a portion of the fibrin forms after injection, with the proviso that a corticosteroid is absent from the fibrin sealant injected into the disc.
Type: Application
Filed: August 17, 2005
Issued: May 4, 2006
Inventors: Kevin Pauza, Brian Burkinshaw, Steven Whitlock, Mark Richards, James Rogan

Injection of Fibrin Sealant Using Reconstituted Components in Spinal Applications

Application number: 20060095075
Abstract: A method of treating a disc that is leaking nucleus pulposus through at least one defect in the annulus fibrosus. The method includes injecting a fibrin sealant into the disc to reduce at least a portion of the at least one defect, wherein the fibrin sealant injected into the disc comprises fibrinogen and an activating compound, wherein at least a portion of the fibrin forms after injection, wherein the fibrinogen, the activating compound or both has been reconstituted with a solution containing at least one additive, with the proviso that a corticosteroid is absent from the fibrin sealant injected into the disc.
Type: Application
Filed: August 17, 2005
Issued: May 4, 2006
Inventors: Brian Burkinshaw, Steven Whitlock, Kevin Pauza, Mark Richards, James Rogan

Concentrated Fibrin (Discseel® Procedure) Study Summaries Disc Pain:

  • Disc pain is among the largest sources of low back pain
  • No conservative or non-surgical therapy, including physical therapy, is scientifically proven to relieve disc pain
  • Long term surgical success is less than 50%

Disc Degeneration Causes:

  • Vertebral endplate sclerosis
  • Accumulation of painful and damaging inflammatory proteins and proteolytic enzymes
  • Nucleus Pulposis death
  • Disc reduction in proteoglycan and water content
  • Nucleus Pulposis fibrosis

Chronic Disc Pain Associates With:

  • Accumulation of radial and concentric anulus fibrosis tears
  • Vascular and painful nerve in-growth into anular tears
  • Increased sensitivity to pain stimuli of exposed nerves

Discseel® Procedure Characteristics:

  • The Biologic flows into the disc's tears and fissures, thus sealing them with a resorbable tissue matrix
  • Concentrated fibrin (Discseel® Procedure) is uniquely formulated for disc healing

Healing with Concentrated Fibrin:

  • Builds a naturally conductive tissue scaffold
  • Metabolically reduces inflammation
  • Improves anabolic catabolic balance
  • Enhanced disc healing by concentrated fibrin

Pain Relief Resulting From Concentrated Fibrin (Discseel® Procedure):

  • Concentrated fibrin binds to degenerated disc tissue, sealing anular leaks
  • Inhibits inflammatory cytokines and proteolytic enzymes
  • Pre-programmed degradation of concentrated fibrin stimulates tissue repair via chemotaxis
  • The disc tissue repair provides sustained pain relief

Conclusion:

  • The FDA study proves concentrated fibrin heals degenerated discs
  • Catalyze the natural soft tissue repair process
  • The Discseel® Procedure is a non-surgical, percutaneous procedure
  • Unlike fusions or artificial discs, the Discseel® Procedure does not damage adjacent discs.
  • FDA NASS Outstanding Study of the Year supports concentrated fibrin used in the Discseel® Procedure beneficial physical and metabolic modes of action