Miami Project 5th Annual Community Open House April 11, 2015 – 12-5pm Lois Pope LIFE Center, University of Miami 1095 NW 14th Terrace, Miami, FL 33136 Topics: Current Clinical Trials for SCI Hurdles in Translation from Lab to Clinic Behind-the-Scenes Tours ***RSVP required: _305-243-7108_ (tel:305-243-7108) or _mpinfo@med.miami.edu_ (mailto:mpi...@med.miami.edu) NEW SCHWANN CELL CLINICAL TRIAL FOR CHRONIC SCI IS OPEN At long last, we have begun our first clinical trial testing autologous human Schwann cell (ahSC) transplantation in people living with chronic spinal cord injury (SCI). This is also a Phase I trial focused on safety and feasibility outcomes. As we announced in October 2014, we obtained FDA approval after having submitted for review additional data regarding transplantation of Schwann cells into rodents and some pigs with chronic SCI. We now have ethics approval from the University of Miami Institutional Review Board and are open for enrollment. This new trial will be primarily focused on safety, but in addition it will involve a preliminary evaluation of the efficacy of combining Schwann cells with exercise and rehabilitation. For humans with chronic SCI, we hypothesize that axons might show improved function if myelin repair is induced with the implantation of ahSC. In addition, spinal cord cavitation may be reduced and neural sprouting and plasticity may be enhanced via neurotrophic effects. In this trial, participants will receive fitness conditioning and locomotor rehabilitation prior to transplantation in order to validate the stability of their neurological baseline and enhance their ability to undergo surgery with few complications. They will also receive fitness conditioning and rehabilitation post-transplantation to maintain health and promote neuronal activity and potential neuroplasticity. We only have FDA approval to transplant a maximum of 10 people – remember that it is a Phase I safety trial. In order to reduce risk, there are a number of inclusion and exclusion criteria. You may qualify if you have had a traumatic SCI at least 1 year ago between the spinal levels of C5-T12, if you are between the ages of 18 and 65, and you have no major health issues. There are 5 stages of Screening to progress through before the actual Schwann cell transplantation occurs and each participant’s time commitment to the trial will be approximately 10 months. They will be followed in a separate long-term monitoring protocol annually for a total of 5 years post-transplantation. To find out more information about the trial and pre-screening, contact The Miami Project Education Department at _305-243-7108_ (tel:305-243-7108) or _MPinfo@med.miami.edu_ (mailto:mpi...@med.miami.edu?subject=New%20Schwann%20Cell%20Clinical%20Trial%20for%20Chronic%20SCI%20is%20Open) . More information about all of our clinical trials and studies is available at _http://www.themiamiproject.org/trials_ (http://www.themiamiproject.org/page.redir?target=http://www.themiamiproject.org/trials&srcid=6670&srctid=1&erid=3890403&; trid=231bea1c-672a-4d61-83e3-9f6952f7b8b2) . FREQUENTLY ASKED QUESTIONS IN THE LAST MONTH 1. When will the cervical portion of the Schwann cell trial begin? Why are they starting with Thoracic level injuries? -The Cervical level injuries will begin after the thoracic level injures cohort is completed. That will be completed when we successfully enroll 4 Thoracic level injury participants with ASIA levels A, B, and or C. The reason we are beginning with Thoracic level injuries is because it is a safety precaution dictated by the FDA. 2. When should we hear back to see if we will proceed on to the next step? - Katie Nagel will be contacting everyone that has done a phone screen with us in a timely manner. Please keep in mind that she has many people to contact, but I assure you that she will get to you as soon as possible. 3. When will the information/findings on the acute trial be made available to us? - We are still actively recruiting for the acute trial. When that study is completed, it takes about a year or so to analyze the data and construct a publication. So you should anticipate a publication on our findings in a scientific journal in the next couple years. If any developments occur before then, we will be sure to keep you updated. SURVEY ABOUT PAIN AFTER SPINAL CORD INJURY – STILL OPEN Researchers at the Miami Project are conducting a web-based survey regarding day-to-day experiences of people living with spinal cord injury (SCI) and chronic pain. In most cases pain remains a major problem, despite our best treatments. The purpose of this study is to learn from the perspectives of people who are living with this pain. The information regarding the personal experiences of living with SCI and chronic pain is needed to improve the understanding and management of this difficult condition, and will benefit the general SCI community including Veterans, their families, and caregivers. Everyone with persistent pain after a spinal cord injury has a unique experience. We would like to hear about yours! Access the survey here: _www.surveymonkey.com/s/SCIpain_ (http://www.surveymonkey.com/s/SCIpain) HUMAN STUDIES FOR CHRONIC SCI BEING CONDUCTED AT THE MIAMI PROJECT The Miami Project clinical researchers currently have 17 research studies available for people who have had a spinal cord injury. They are investigating questions regarding exercise science, rehabilitation training, pain, male fertility, aging, and neuroprosthetics. To learn more about these studies and how to participate, please visit http://www.themiamiproject.org/trials . CURRENT SCI CLINICAL TRIALS _http://clinicaltrials.gov/ct2/results?term=%22spinal+cord+injury%22&recr=Op en&no_unk=Y_ (http://clinicaltrials.gov/ct2/results?term="spinal+cord+injury"&recr=Open&no_unk=Y) Best wishes! Kim Kim Anderson-Erisman, Ph.D. Associate Professor, Department of Neurological Surgery Director of Education, The Miami Project to Cure Paralysis Lois Pope Life Center 1095 NW 14th Terrace, Room 1-31, Mail Locator R-48 University of Miami Miami, FL 33136 Office: _305-243-7108_ (tel:305-243-7108) Fax: _305-243-3913_ (tel:305-243-3913) _KAnderson3@med.miami.edu_ (mailto:kanders...@med.miami.edu) _www.themiamiproject.org_ (http://www.miamiproject.miami.edu/)
