What stands in the Way becomes the Way.

The ASPIRE study is currently enrolling participants who are at least 22 years of age and have a traumatic, chronic* spinal cord injury between C2 and T2


Welcome to Unite 2 Fight Paralysis' 17th
Annual Science and Advocacy Symposium. We are excited to finally be back with so many of you in person this year! We look forward to facilitating meaningful exchanges among the key members of our communities engaged in our shared work. Paying attention to the following areas will help us maximize our time together. COVID Protocols. Despite our enthusiasm to be back together, we know that Covid is not over. We strongly encourage our in-person attendees to join our board and staff in exhibiting the following safety precautions: • Wear a mask during the meeting • Get fully vaccinated and boosted if not already up to date • Wash hands and use hand sanitizer often • Take a rapid test prior to joining the conference Interactive Program. We have reduced the size of our printed program to save paper and utilized QR codes to create what we hope will be a more accessible and convenient way for all attendees to access key information, such as: • Speaker Abstracts and Bios • U2FP staff, leadership and organizational history • Resources for the SCI Community Scan here to download a digital version of this program and/or use the QR codes provided on the following pages.
Format. Each day of the Symposium will contain presentations from our all-star lineup of scientists and advocates. Moderated question and answer sessions will follow each grouping of 2-3 presenters. Use this program to educate yourself on what's coming up so that you can prepare to engage effectively. This is a fantastic opportunity to pose your questions directly to the presenters and enrich the experience for all.
Context. Please read through Sam Maddox's "Navigating U2FP's Science & Advocacy Symposium" in the following pages. It's a great overview and highlights the salient points that connect the various researchers to the cure enterprise. As always, we are committed to providing context both in and around the research in order for our communities to think strategically about what is happening and explore ways to have an increasingly effective voice toward expediting curative treatments for SCI. Keep these questions at the forefront: What is happening? Where does it go next? Who can take it there? How can we help?
Sponsors. We are so very grateful to our sponsors this year. Please take some time to visit their exhibiting booths and/or talk to their representatives to discover the great work they are doing in our community. Lastly, take a few minutes to fill out our survey at the end of the symposium. We very much want to hear your impressions. And if you have any questions, reach out to us at unite@u2fp.org

SponSor ExhibitorS
Our sponsors help make U2FP's Annual Symposium possible -they also provide a tremendous array of resources, services and products for the SCI Community. Sponsors will be available at several exhibit tables in the Canyons Lobby area outside of the Ballroom. Please take a moment to stop by and learn more about their unique offerings for our community. Welcome to the 2022 Science and Advocacy Symposium. We're grateful we can finally meet in person again here in Salt Lake City. The livestream experience of the last two years was quite successful and will be an option again this year. But there's nothing to compare with the experience of being here in person.

GEt ConnECtED
The aim of the Symposium is to bring you up to speed on the complicated science of repairing the injured spinal cord and on the strategies needed to move discoveries toward treatments. Science can be difficult to explain, so you are not alone if you feel a little overwhelmed. One of the unique advantages of this Symposium is that the roster and schedule are built around participation. Lay people mix it up with the experts, and vice versa. Scientists very much want to meet members of the SCI community and their families. It humanizes and focuses their work.

keeping a Wide View
We're not there yet. No treatment has ever been approved for either acute or chronic SCI in humans -but optimism rules! There are exciting possibilities on the horizon, some already in clinical trials, others in the biotech start-up pipeline. The work is hard, and it moves slower than our expectations for it. The leap is vast from a promising SCI mouse recovery you heard about in the news to an actual treatment at your doctor's office.
Therapies start out as ideas that worked in a lab animal. Then, if something looks promising, and money is available, clinical people take over, or sometimes a company gets involved ahead of them . If trials succeed in meeting outcome expectations (this stage has never been reached in SCI) regulatory approvals are the next hurdle. Commercialization has its own challenges to scale up to meet the market, including locking down patent rights and insurance reimbursement.
The U2FP approach invites all interested parties along this translational pathway to the podium -scientists, clinicians, funders, industry people, regulatory people, along with advocates from the SCI community -to deconstruct the system so it operates more smoothly while remaining focused on the unmet needs of the community.

Basic Questions
To help frame the discussions at the Symposium, let's reduce spinal cord injury to a general range of problems researchers are trying to solve. Let's start with the most basic question: What does an injury actually do to the cord?
(Note: We recognize the important medical value of neuroprotection and acute SCI treatment development, however our focus is on chronic injury.)

Navigating
The spinal cord is usually injured by a high impact event, a force that exceeds the protective armor of the backbone. Some nerve cells in the injury zone die right away, others die in the hours and days after the injury site seals itself off and becomes toxic to nerve cells. Trauma also disrupts the basic architecture of the spinal cord. Could we perhaps REBUILD the mangled cord structure or add cells to encourage recovery? Some spinal cord cells survive trauma but lose their axons, the long extensions like wiring. Research tells us these cells attempt to recover and resend axons but get stuck or repelled. Could we find a way to REGENERATE native cells and then direct their axons to make the appropriate connections? Other cells and nerve networks in the injured spinal cord are alive but dormant or disconnected from the information circuits between the brain and the cord. Can we REJUVENATE the spared part of the system, tapping into inherent self-repair mechanisms, or perhaps the smartness and adaptability of the spinal cord itself?

Getting Started
U2FP executive director Matthew rodreick welcomes all to the Symposium and suggests a metaphoric platform or process that includes all perspectives (science, medicine, industry, funders, community). He imagines the need for effectual tension, as with spokes on a wheel, to deliver solutions for all the interested parties.
Note to SCI community: You have a very important role to play in keeping up your end of the tension -make sure the other stakeholders understand your urgency for treatments. Solzbacher's company makes the electrode array (the Utah Array) used in most studies of brain-computer interface (BCI) research. His presentation is titled, "It Won't Work: The Perception Challenge Facing Commercial BCIs." The tech is solid, the results are solid, the potential market is vast. What's the hold up? It's the perception that implantable BCIs are too risky, can't be approved and can't make money. He discusses how patient advocates, potential users, caretakers, physicians and businesspeople can challenge the perception.

Down to Business
Corson is Deputy Director & Senior Director of Innovation of the PIVOT Center, University of Utah. PIVOT creates Greenhouses, a controlled environment to support the growth of invention. Greenhouses are managed by successful entrepreneurs and industry leaders who partner with university researchers and private sector stakeholders to identify opportunities, create realistic business plans, and arrange funding for technology development. The focus is on reducing risk in both technology and marketplace.
Collett addresses the many challenges for a biopharma company in developing a therapeutic for SCI -including the fact that previous attempts to treat SCI have not been successful. This creates a perception that the nervous system is not amenable to repair, and limits investments from financial markets. She discusses NervGen's need to explore unconventional funding mechanisms, and disease treatments beyond SCI, to attract investors. (The company's peptide, NVG-291, will begin its first clinical trial in individuals with SCI in 2023.)

Who needs rehab?
Dale Hull was spinal cord injured in 1999, C4-5 cervical injury, initially resulting in neck-down paralysis. He spent the following two years participating in intense rehabilitation. In 2004, he and physical therapist Jan Black opened Neuroworx, a not-for-profit, outpatient rehabilitation facility in Sandy, UT. Hull discusses the critical significance of aggressive physical and occupational rehab in the first 24 months post injury. This is when people need the best tools and direction to attain maximal recovery. It is also when people should acquire adaptive skills and get counseling for mental health, relationships, and work life to assure full participation in the community.

Special Film Screening: Move Me
U2FP is proud to present a special screening of Move Me, the long-anticipated documentary film from kelsey Peterson. The feature length film tells Kelsey's story: high-level spinal cord injury, loss, and heartbreak, and now, 10 years later, an attempt to balance hope for recovery with acceptance that life with a disability has intrinsic value and meaning. U2FP has been involved with the film from the start; the project began as The Cure Map, a cure-seeker's journey that evolved into a story of self-discovery.
After the film, U2FP CureCast co-host Jason Stoffer will moderate a discussion with Peterson and Quinn Brett.

regeneration
Jerry Silver teaches at Case Western University. Damaged spinal cord nerve cells attempt to regrow their axons, but the trauma site becomes quite toxic and sealed off. In theory, it's possible to restart nerve growth by recoding developmental genes, using molecular decoys or drugs to remove the scar; or cultivating long axons across the injury site, perhaps along a scaffold. That brings us to Silver and the start-up company, NervGen, based on his work. He's the veteran SCI scientist and frequent U2FP Symposium presenter who has never abandoned hope for axon regeneration.
Silver has long understood the role of spinal cord scar and chondroitin sulfate proteoglycans (CSPGs) to block axons. There are ways to chemically degrade these inhibitors. Here he will discuss recent work utilizing a new, more clinically relevant, non-invasive combination treatment designed to reduce and overcome CSPGs. Results so far: a "profound effect on functional recovery" in a chronic animal model of SCI.
Combo matchmaking update: The project is on! Shortly after the 2021 Symposium, U2FP proposed the pairing of Silver, NervGen, Candace Floyd, and Ann Parr, a University of Minnesota neurosurgeon and co-project leader of the E-STAND epidural stim trial. The idea: test a combination of Nerv-Gen's peptide with eSCS in a large animal chronic SCI model -is stim + drug better than either alone? Funds were raised from several SCI charities; animal testing will begin this fall for this unique, multidisciplinary study, using the NervGen's peptide drug (NervGen/Silver), adding epidural stimulation (Parr), in a clinically relevant pig model (Floyd).

rejuvenation
This involves waking up nerve cells that are alive and home where they should be, but not functioning in harmony with spinal cord circuitry. This sets up the major Symposium discussion on spinal cord stimulation (SCS). We are pleased to include presentations from reggie edgerton and Susan Harkema, pioneers in neuromodulation who led the team that implanted an epidural stimulation device 13 years ago in a motorcomplete paraplegic who could then stand with the stim on. That result ignited the neuromod field and launched many new projects, and several device development companies. David Darrow follows, reviewing his contribution and experiences implanting spinal cord stimulators using a novel patient-centric approach. edgerton, considered the grandpa of spinal cord stimulation, has been at the research bench for nearly six decades. His work at UCLA underpins the entire field. He will be introduced at the Symposium by Jack Jablonski, injured in 2011 during a Minnesota high school hockey game. The Jack Jablonski Foundation has supported Edgerton's work for several years.
Spinal cord stim is based on the notion that spinal cord nerve cells have a kind of automatic programming for messaging motor/muscle cells; the cord can be independently smart and active, even with no connection to the brain. Spinal cord activation can occur to some degree with intensive physical therapy, but much more so by applying pulses of electrical energy by way of an implanted device or via skin surface electrodes -in both cases, some people, not all, have gained meaningful voluntary function that often remains when the stim device is turned off. Apparently, stimulation is more than a jolt of electricity, it encourages what scientists call plasticity -the cord circuitry adapts and rewires itself permanently.
Here Edgerton will dive into spinal cord physiology with an eye on how the cord manages movements, posture, and locomotion. He suggests that "sensory ensembles" (input from touch, sight, hearing, taste, etc.) contribute to highly specific functions.
Up next, Harkema. She and Edgerton go way back -she was a postdoc in his UCLA lab before moving to University of Louisville where she runs the large spinal cord neuromodulation program for the Kentucky Spinal Cord Injury Research Center. Her group has implanted 45 epidural stim units and has published numerous papers detailing standing, stepping and volitional movement.
One of the surprising results of SCS studies, Harkema notes, is that stimulation has a positive effect on whole-body homeostasis. For example, studies have shown that SCS greatly improves blood pressure management. The first clinical approval for a spinal cord stim implant won't be standing or stepping, it will likely be orthostatic hypotension (the dizziness related to sitting or standing up too fast).
Darrow started an epidural stimulation clinical trial in 2017 (E-STAND) while still a neurosurgery resident at the University of Minnesota (funded by a state program created by advocates supported by U2FP and launching the Cure Advocacy Network). Results to date are quite goodstanding, autonomic improvement, bowel and bladder recovery, some volitional movement. What sets Darrow's approach apart from the Louisville group is that he skipped the rehabilitation component. His participants are not required to relocate or pre-train before or after implantation; they get a 90-minute outpatient surgery and go home with a device that allows them to dial in their own stimulation patterns.
In his Symposium talk, Darrow explains that muscles don't work alone to create movement; they work together in groups, or muscle synergies. Stimulation restores dormant muscle synergies after SCI, but they are not Stupp reported that his little nano-bridges delivered molecules inside a spinal cord injury site that improved function and promoted repair. In animals, he saw locomotor recovery, axonal regeneration, and reduced glial scarring. His 2021 study reported on a "mild" mouse injury. Here he will discuss newer results with a more severely injured animal and will speculate on his hopes to take this scaffold strategy to humans.

John C. Gensel is Acting Director of the Spinal Cord and Brain Injury
Research Center at the University of Kentucky College of Medicine. He studies inflammatory responses to spinal cord injury. Here he addresses his "mid career crisis:" Having spent 20 years working with suboptimal animal models, will that path actually help humans with SCI? Or do we need to refine the model to encourage data gathering that better reflects such factors as age and sex. In other words, can the mouse model be humanized? Valerie Dietz is a PhD candidate at Texas A&M University who talks about clinical trials for SCI. There are more trials than ever yet still we have no treatments. Could the way trials are conducted and reported be part of the problem? She found that of 1149 interventional SCI clinical trials listed at clinicaltrials.gov, 80 percent designated as "completed'' do not have results posted. Wouldn't it be good to know if a human study met its endpoints? Some of those results show up in published literature but this is a major omission that must be addressed.
Jason Biundo was injured in 2019 in a climbing accident. That lifechanging event shifted his research interests to the SCI field; he joined the Zhigang He lab at Boston Children's Hospital. Here, Jason advocates for the SCI community to be involved in the research process. Biundo serves on a consumer advisory board organized by the North American SCI Consortium (NASCIC) to design more relevant, patient-focused outcome measures for clinical trials for functional movements (see next session, Advocacy Workshop.)

Workshops
Barry Munro, one of the founders of NASCIC and Chief Development Officer of the Canadian Spinal Research Organization, leads the discussion on how people living with paralysis can improve the research process by becoming part of laboratory science. Hint: you don't need a PhD but it helps to know how things work -there's training coming for that. NASCIC is developing an SCI Research Advocacy Course to prepare individuals with SCI and caregivers to serve as research advocates. Munro, who is also on the Board for U2FP, will describe our "lab rats" program, which is actively placing people with SCI in labs.
Matthew rodreick formed a translational workgroup (called T4) including scientists, clinicians, industry partners, and individuals with SCI to better understand the biomedical therapy development system and how research is and is not translated to therapies. The mission: "Drive the delivery of restorative treatments for spinal cord injury by reimagining the therapy development pipeline." Members of the group (Michael Lane, Lana Zholudeva, and Dennis Bourbeau) will raise questions and provoke conversation with attendees about the barriers, challenges, incentives and opportunities as defined from over 70 interviews conducted by the group with SCI stakeholders.
If you want to reach out to us, email Matthew Rodreick, matthewrodreick@u2fp.org

Resources
Scan here to view all of the below information with direct links to each of these resources.
The goal of the SCITrialsFinder.net website is to allow individuals with spinal cord injury (SCI), their families and health care professionals to get common language information about clinical trials as developed by experienced clinical investigators. apply to clinical trials quickly and directly in the web site.
SciTrials.org provides the community with a way of finding clinical trials that are relevant to each individual in the fastest way possible by enabling individuals to search via location and injury details; receive email updates on new trials of interest to them; find answers for the most common questions about trials; access clinical information distilled into everyday language; apply to clinical trials quickly and directly in the web site.
This data sheet is a quick reference on demographic and condition statuses for 35,675 persons with SCI in the United States. Data were collected through 2021 by federally funded SCI Model Systems and five Form II (follow up) centers and entered into the National SCI Database.
STEM CELL FACTS is a useful publication for understanding the basics of stem cells. It is put out by the International Society for Stem Cell Research (ISSCR). The ISSCR is an independent, nonproft organization providing a global forum for stem cell research and regenerative medicine The MSKTC works closely with researchers in the 14 Spinal Cord Injury (SCI) Model System Centers to develop resources for people living with spinal cord injury and their supporters. These user-friendly resources are grounded in evidence and available in a variety of formats such as printable PDF documents, videos, and slideshows.
The NASCIC Research Advocacy Course is designed to educate and empower individuals with spinal cord injury, researchers and clinicians, and caregivers who wish to become more involved with Clinical Research relating to SCI at all levels.
the Art

CRACKS IN THE UNIVERSE by Kristen Verhey, Ph.D.
A neuron cell body with several fine extensions (dendrites, colored blue) to transmit information along nerve circuits.

THOUGHTS OF CHERRY PIE by Tyler Burns
Neuronal nuclei (red) within the mouse cerebral cortex, surrounded by a mesh of axons wrapped in myelin (green).

CIRCUIT CITY by Dawen Cai, Ph.D.
A tangle of individual nerve circuits in a genetically modified mouse brain, mapped here in red, blue, and green. It's what happens when you combine 57 years of exceptional patient care with a facility built to provide an inspiring and healing environment.

UPS AND DOWNS
With world-renowned physicians and clinicians, Craig H. Neilsen Rehabilitation Hospital is proud to share our exceptional capabilities and outcomes in spinal cord injury, traumatic brain injury, dual diagnosis, polytrauma, burns, and amputations. Today, we are the leading destination in the mountain west for treating complex cases.

C H A L L E N G E T H E I M P O S S I B L E .
The ASPIRE study is currently enrolling participants who are at least 22 years of age and have a traumatic, chronic* spinal cord injury between C2 and T2, but who maintain limited function of the upper extremities. Participants must be willing to cooperate with the study requirements, including compliance with the treatment plan and completion of all office visits. A miracle delayed is even more miraculous.
Conventional wisdom holds that recovery from spinal cord injury ceases after two years. We're not conventional, and we never say "never." Our groundbreaking activity-based restorative therapies help children and adults with chronic paralysis regain sensation, function, mobility and independence, even many years after injury. Don't lose hope; learn more.

NEUROREHABILITATION & RESEARCH HOSPITAL
▪ A full-service contract research organization focused on SCI research ▪ Conducting acute and chronic SCI clinical trials since 1994 ▪ Expertise includes drugs, devices, autologous and stem cells ▪ Strong relationships with SCI leaders, key professionals, and rehabilitation facilities ▪ A team that will be a strategic partner, knowledgeable in SCI clinical outcomes and efficacy assessments.

Your SCI CRO Solution Partner
If you are looking for an experienced SCI partner to help you with your next clinical trial, contact DP Clinical/Jim Hamer at 301.294.6226 x612 or jhamer@dpclinical.com 9201 Corporate Blvd, Rockville, MD 20850 ~ www.dpclinical.com CPN assists people affected by paralysis and other neurological conditions to help put them on the road to independence. We enable trailblazing spinal cord research and are an advocate of making the world aware of the need to conquer paralysis.

ConquerParalysisNow.org
Contact us at info@conquerparalysisnow.org

WE ARE
a research and clinicalstage biomaterials and biotechnology company, focused on redefining the treatment of spinal cord injury.
To learn more, please visit invivotherapeutics.com.
InVivo-Print-Ad.indd 1 7/26/22 12:18 Push to Walk Our Mission The mission of Push to Walk is to provide individualized workouts and resources to people with spinal cord injuries and other forms of paralysis to optimize current quality of life and to prepare for future medical advancements.