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Current concepts in the research and use of spinal biologics will be reviewed during this course.  Pertinent topics will be covered ranging from regenerative medicine for bone repair, to spinal cord injury, to future solutions for disc degeneration.  The format will focus on a literature review of critical analysis topics followed by critique and discussion from the world's experts in these fields.

This course includes videotaped podium presentations in conjunction with audio and slides.  A post-course evaluation will be given to help reinforce your knowledge.

This course was originally presented to a live audience at the NASS 25th Annual Meeting in Orlando, FL, on October 5, 2010, and has been adapted for online presentation.

Course Chairmen:
Hyun Bae, MD

Faculty:
Howard S. An, MD
Susan Bukata, MD
Timothy T. Davis, MD
David E. Fish, MD, MPH
Michael H. Heggeness, MD, PhD
Wellington Hsu, MD
David H. Kim, MD
Brian Kwon, MD
Brian K. Kwon, MD, PhD, FRCSC
Thomas E. Mroz, MD
Rakesh D. Patel, MD
Alfred Rhyne, MD
Francis H. Shen, MD
Gwendolyn Sowa, MD, PhD
Michael P. Steinmetz, MD
Jeffrey C. Wang, MD
Peter G. Whang, MD
S. Tim Yoon, MD, PhD

Learning Objectives
Upon completion of this course, participants should be able to:

• Review pertinent and current literature regarding critical analysis topics of spinal biologics such as disc regeneration, bone graft substitutes for spine fusion, stem cell research in spinal cord injury, and neurostimulation for pain.
• Assess the principles behind treatment modalities for cell-based applications, growth factors, and targeting the basilovertebral nervous plexus as a source of back pain.
• Identify future directions of treatment for spinal disorders such as degenerative disc disease, bony fusion, and spinal cord injury.

• Introduction & Course Objectives (Bae)
• Regenerative Medicine for Spinal Repair
  o Stem Cells for Regenerative Therapies (Shen)
  o Understanding the Biology and Biologic Therapies in Disc Degeneration (Sowa)
  o Spinal Cord Injury and Repair (Kwon)
  o Anabolic Molecules for Bone Regeneration (Not BMPs) (Bukata)
• Critical Analysis: Synthetic Bone Graft Substitutes
  o Overview and Evidence (Whang)
  o Expert Critique and Criticism (Patel)
• Critical Analysis: Stem Cell Enhanced Allografts
  o Overview and Evidence (Hsu)
  o Expert Critique and Criticism (Steinmetz)
• Critical Analysis: Generic BMPs
  o Cheap BMPs and Alternatives are Coming (Bae)
  o Expert Critique and Criticism (Mroz)
• Critical Analysis: Genetic Diagnostics for Scoliosis and DDD
  o Overview and Evidence (Kim)
  o Expert Critique and Criticism (Kwon)
• Critical Analysis: Intraosseous Sources of Back Pain: Intraosseous Nerves and the Concept of Vertebrogenic Pain
  o Overview and Evidence (Heggeness)
  o Expert Critique and Criticism (Rhyne)
• Critical Analysis: Neurostimulation for Treatment of Pain
  o Overview and Evidence (Fish)
  o Expert Critique and Criticism (Davis)
• Critical Analysis: Molecular Therapies for Disc Regeneration
  o Overview and Evidence (An)
  o Expert Critique and Criticism (Yoon)
  

Continuing Medical Education (CME) Information
This activity has been planned and implemented in accordance with the Essential Areas and Standards of the Accreditation Council for Continuing Medical Education (ACCME). The North American Spine Society is accredited by the ACCME to provide continuing medical education for physicians and takes responsibility for the content, quality and scientific integrity of this CME activity.

The North American Spine Society designates this enduring material for a maximum of 3.75 AMA PRA Category 1 Credit(s)™.

Physicians should claim only the credit commensurate with the extent of their participation in the activity.  The American Medical Association has determined that physicians not licensed in the US to participate in this CME activity are eligible for AMA PRA Category 1 Credits™.

This course was released on 7/26/2011, and is available for purchase through 7/25/2014.

Appropriate Audience
Target audience includes: Researchers and spine specialists who want to learn unbiased, comprehensive, current concepts of biological treatments for and research of spinal conditions from a scientific perspective.

Conflict of Interest Disclosure
All faculty members provided estimated dollar amounts per the NASS Disclosure Policy through the NASS online disclosure module. NASS staff then translated that information into dollar ranges for purposes of this index, as well as for presentation at the live course. These ranges are as follows:

• None: Existing relationship but no remuneration in prior calendar year
• Level A: $100 to $1000
• Level B: $1,001 to $10,000
• Level C: $10,001 to $25,000
• Level D: $25,001 to $50,000
• Level E: $50,001 to $100,000
• Level F: $100,001 to $500,000
• Level G: $500,001 to $1M
• Level H: $1,000,001 to $2.5M
• Level I: Greater than $2.5M
  

An, Howard S.: Royalties: U&I (E); Consulting: DePuy Spine (B), Zimmer Spine (B), Life Spine (A), Baxter (B); Speaking and/or teaching arrangements: Rush University Medical Center (Endowed Chair and Professor at Rush University Medical Center, D); Board of Directors: Articular Engineering LLC (18% equity); Scientific Advisory Board: Pioneer (15,000 shares), Spinal Kinetics (10,000 shares); Other Office: International Society for the Study of the Lumbar Spine (President-elect, Board of Directors); Endowments: Rush University Medical Center (D); Grants: NIH (F); Fellowship Support: DePuy Spine (E), Synthes (E).

Bae, Hyun W.: Royalties: NuVasive (F), Stryker (F), Zimmer (C), Biomet (C), Spine Wave (B); Stock Ownership: Spine Wave (54,000 shares, <.1%); Private Investments: Small Bones (<.1%); Consulting: Synthes (B); Speaking and/or teaching arrangements: Stryker (C); Trips/Travel: Spine Research Foundation (B); Scientific Advisory Board: Spinal Restoration (10,000 stock options), Nexgen Spine (10,000 stock options); Research Support (Staff/Materials): Paradigm (D); Grants: Orthovita (C).

Bukata, Susan: Consulting: Eli Lilly (B); Speaking and/or teaching arrangements: Eli Lilly (B); Scientific Advisory Board: MTF (University of Rochester Representative, Paid directly to institution/employer); Research Support (Investigator Salary): NIH (C).

Davis, Timothy T.: Private Investments: Paradigm Spine (1,000 shares); Speaking and/or teaching arrangements: St. Jude Medical (Amount not disclosed); Trips/Travel: St Jude Medical (Amount not disclosed); Other Office: Alpha Diagnostics (Owner).

Fish, David E.: Consulting: Allergan (Amount not disclosed); Speaking and/or teaching arrangements: Sanofi-Aventis (Amount not disclosed); Grants: Medtronic (C); Fellowship Support: Boston Scientific (B).

Heggeness, Michael H.: Royalties: Relievant Medsystems (C); Stock Ownership: Relievant Medsystems (45,000 shares, 1.6%); Consulting: Relievant Medsystems (D); Research Support (Investigator Salary): Department of Defense (E); Grants: Department of Defense (I, Paid directly to institution/employer).

Hsu, Wellington: Speaking and/or teaching arrangements: Stryker (B); Trips/Travel: Stryker (A); Research Support (Staff/Materials): Medtronic (F); Grants: Pioneer Surgical (E).

Kim, David H.: Stock Ownership: Axial Biotech (150,000 shares, 1%); Consulting: Axial Biotech (E), Pioneer (B), DePuy (B), Medtronic (B); Speaking and/or teaching arrangements: DePuy (B), Medtronic (B), Stryker (B); Trips/Travel: Stryker (B), Medtronic (B); Scientific Advisory Board: New England Baptist Hospital (None); Research Support (Staff/Materials): New England Baptist Hospital (D); Grants: New England Baptist Hospital (D).

Kwon, Brian: Stock Ownership: ETEX (20,000 shares, Tissue Bank Director); Consulting: Stryker Spine (Amount not disclosed), Aesculap Spine (Amount not disclosed); Speaking and/or Teaching Arrangements: Stryker Spine (Amount not disclosed); Trips/Travel: Stryker Spine (A);  Other Office: ETEX (Stock ownership disclosed).

Kwon, Brian K.: Consulting: Medtronic (D).

Mroz, Thomas E.: Speaking and/or teaching arrangements: AO Spine (B), Stryker (B).

Patel, Rakesh D.: Nothing to Disclose.

Rhyne, Alfred L.: Royalties: Stryker (F, Paid directly to institution/employer); Stock Ownership: Pioneer (90,000 shares); Consulting: Stryker (Amount not disclosed); Speaking and/or Teaching Arrangments: Stryker (Amount not disclosed); Trips/Travel: Stryker (Amount not disclosed).

Shen, Francis H.: Royalties: Globus Medical (Amount not disclosed), Elsevier Publishing (B); Consulting: Synthes Spine (C), DePuy Spine (B); Speaking and/or teaching arrangements: DePuy Spine (B); Board of Directors: Musculoskeletal Transplant Foundation (B, Paid directly to institution/employer); Scientific Advisory Board: Kuros Biomedical (B); Research Support (Investigator Salary): OREF (E); Fellowship Support: AO Spine (D).

Sowa, Gwendolyn A.: Nothing to Disclose.

Steinmetz, Michael P.: Nothing to Disclose; Relationships Outside the One Year Requirement: Stryker Spine (12/2009, B).

Wang, Jeffrey C.: Royalties: Medtronic (D), Stryker (E), Seaspine (E), Osprey (B), Aesculap (B), Biomet (F), DePuy (B), Amedica (B), Zimmer (C), Alphatec (F); Stock Ownership: Fziomed (2,500 shares, less than 1%); Private Investments: Promethean Spine (less than 1%), Paradigm spine (less than 1%), Benvenue (less than 1%), NexGen (less than 1%), K2 medical (less than 1%), Pioneer (less than 1%), Amedica (less than 1%), Vertiflex (less than 1%), Electrocore (less than 1%), Surgitech (less than 1%), Invuity (less than 1%), Axiomed (less than 1%); Board of Directors: North American Spine Society (Amount not disclosed), Cervical Spine Research Society (Amount not disclosed); Scientific Advisory Board: VG Innovations (options valued at less than 1% of company), Corespine (options valued at less than 1% of company), Expanding Orthopaedics (options valued at less than 1% of company), Syndicom (shares valued at less than 1% of company), Osprey (options, less than 1% of company), Amedica (options, less than 1% of company), Bone Biologics (shares, less than 1% of company), Curative Biosciences (options, less than 1% of company), Facet Solutions (options, less than 1% of company), PearlDiver (options, less than 1% of company), Pioneer (options, less than 1% of company), Seaspine (options, less than 1% of company), Axis (None).

Whang, Peter G.: Stock Ownership: DiFusion (60,000 shares, 5%); Consulting: Stryker (B); Speaking and/or teaching arrangements: Apatech (C), Stryker (B); DiFusion (Stock ownership disclosed); Other Office: Paradigm Spine (C), Smith & Nephew (B).

Yoon, S. Tim: Royalties: Consulting: Medtronic (B), Meditech Advisors (B); Board of Directors: KASS (President); Other Office: The Spine Journal (Associate Editor); Grants: Biomet Spine (F).

Disclosures are current as of November 1, 2010.

Technical Requirements
The following hardware/software specifications must be met or exceeded to complete this course:

• Web browser and internet connection
• Computer equipped with audio output (speakers or headphones)
• Printer (to print PDF handout)
• Internet Explorer 7 or higher
• Adobe reader 7 or higher
• Microsoft Silverlight (if you do not have the program on your computer, you will be prompted to install it)
• Disable pop-ups

Disclaimer
The material presented is made available by the North American Spine Society for educational purposes only. The material is not intended to represent the only, nor necessarily the best, method or procedure appropriate for the medical situations discussed; rather, it is intended to present an approach, view, statement or opinion of the faculty, which may be helpful to others who face similar situations. NASS disclaims any and all liability for injury or other damages to any individual attending the meeting and for all claims which may arise out of the use of the techniques demonstrated therein by such individuals, whether these claims shall be asserted by physicians or any other person.