Lessons Learned and Recommendations from a SCOPE Spinal Cord Injury Neurorestorative Clinical Trials Update
The Spinal Cord Outcomes Partnership Endeavors presented a clinical trials update (CTU) in collaboration with the International Spinal Research Trust as a precourse to their annual meeting. Selected trials adhered to a priori considerations, prioritizing novelty and a focus on neurorestorative appro...
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| Format: | Article |
| Language: | English |
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Mary Ann Liebert
2025-01-01
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| Series: | Neurotrauma Reports |
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| Online Access: | https://www.liebertpub.com/doi/10.1089/neur.2024.0163 |
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| author | Bethany R. Kondiles Sabhya Rana David Weiner Armin Blesch James St. John Cornelia Haag-Molkenteller Patrick Freund James Guest Daniel D. Mikol Susan Harkema Randy D. Trumbower Michael G. Fehlings Norbert Weidner Gary S. Hogge Edelle C. Field-Fote Marco A.S. Baptista Armin Curt Jane Hsieh Linda Jones |
| author_facet | Bethany R. Kondiles Sabhya Rana David Weiner Armin Blesch James St. John Cornelia Haag-Molkenteller Patrick Freund James Guest Daniel D. Mikol Susan Harkema Randy D. Trumbower Michael G. Fehlings Norbert Weidner Gary S. Hogge Edelle C. Field-Fote Marco A.S. Baptista Armin Curt Jane Hsieh Linda Jones |
| author_sort | Bethany R. Kondiles |
| collection | DOAJ |
| description | The Spinal Cord Outcomes Partnership Endeavors presented a clinical trials update (CTU) in collaboration with the International Spinal Research Trust as a precourse to their annual meeting. Selected trials adhered to a priori considerations, prioritizing novelty and a focus on neurorestorative approaches. The sessions featured 13 speakers, covering 4 in-preparation, 4 in-progress, and 4 recently completed trials. In addition to in-person attendance, individuals worldwide viewed a live stream of the presentations. Approximately 1600 participants, comprising clinicians, researchers, industry stakeholders, foundations, and individuals with lived experiences, engaged in the CTU through both in-person and virtual channels. Presentations represented a variety of approaches, including drug, biological, and device-based therapeutics. This summary provides high-level summaries of the trials presented and the resulting discussions including lessons learned. Rather than recapitulating published data, the presentations and discussions emphasized the novelty and strengths of each trial, practical aspects of translation, and lessons learned. Throughout the day, several discussion themes surfaced. These included reflections on the suitability of outcome measures and the distinction between statistically or clinically meaningful effects and meaningful changes in quality of life. Additional topics included novel trial designs, selection of inclusion criteria, recognizing the indispensable role of rehabilitation, tailoring approaches to individual needs, the importance of integrating lived experience, and emphasizing the importance of establishing robust pre-clinical data packages before venturing into clinical translation. Importantly, strategic directives are summarized to address these challenges, focusing resources and efforts to steer forthcoming trials effectively. |
| format | Article |
| id | doaj-art-8a91cb013e0542789b44c30d8ffc1f48 |
| institution | Kabale University |
| issn | 2689-288X |
| language | English |
| publishDate | 2025-01-01 |
| publisher | Mary Ann Liebert |
| record_format | Article |
| series | Neurotrauma Reports |
| spelling | doaj-art-8a91cb013e0542789b44c30d8ffc1f482025-08-20T03:49:37ZengMary Ann LiebertNeurotrauma Reports2689-288X2025-01-016121023110.1089/neur.2024.0163Lessons Learned and Recommendations from a SCOPE Spinal Cord Injury Neurorestorative Clinical Trials UpdateBethany R. Kondiles0Sabhya Rana1David Weiner2Armin Blesch3James St. John4Cornelia Haag-Molkenteller5Patrick Freund6James Guest7Daniel D. Mikol8Susan Harkema9Randy D. Trumbower10Michael G. Fehlings11Norbert Weidner12Gary S. Hogge13Edelle C. Field-Fote14Marco A.S. Baptista15Armin Curt16Jane Hsieh17Linda Jones18International Collaboration on Repair Discoveries, Department of Zoology, University of British Columbia, Vancouver, Canada.Department of Physical Therapy, University of Florida, Gainesville, Florida, USA.Independent Consultant, New Orleans, LA, USA.Department of Neurosciences, University of California-San Diego, and VA San Diego Healthcare System, La Jolla, California, USA.Clem Jones Centre for Neurobiology and Stem Cell Research, Griffith Sciences and Griffith Health, Griffith University, Australia.EG 427, Paris, France.Spinal Cord Injury Center, Research, Balgrist University Hospital, Zürich, Switzerland.Neurological Surgery and The Miami Project to Cure Paralysis, University of Miami, Miami, Florida, USA.NervGen Pharma Corp., Vancouver, Canada.Kessler Foundation, East Hanover, New Jersey, USA.Department of Physical Medicine & Rehabilitation, Spaulding Research Institute, Harvard Medical School, Boston, Massachusetts, USA.Division of Neurosurgery and Spine Program, Department of Surgery, University of Toronto, Toronto, Canada.Spinal Cord Injury Center, Heidelberg University Hospital, Heidelberg, Germany.GSH Biomedical Consulting, San Francisco, California, USA.Hulse Spinal Cord Injury Research, Shepherd Center, Atlanta, Georgia, USA.Christopher & Dana Reeve Foundation, Short Hills, New Jersey, USA.Balgrist University Hospital, Zürich, Switzerland.Wings for Life, Salzburg, Austria.Christopher & Dana Reeve Foundation Short Hills, New Jersey, USA; Thomas Jefferson University, Philadelphia, Pennsylvania, USA.The Spinal Cord Outcomes Partnership Endeavors presented a clinical trials update (CTU) in collaboration with the International Spinal Research Trust as a precourse to their annual meeting. Selected trials adhered to a priori considerations, prioritizing novelty and a focus on neurorestorative approaches. The sessions featured 13 speakers, covering 4 in-preparation, 4 in-progress, and 4 recently completed trials. In addition to in-person attendance, individuals worldwide viewed a live stream of the presentations. Approximately 1600 participants, comprising clinicians, researchers, industry stakeholders, foundations, and individuals with lived experiences, engaged in the CTU through both in-person and virtual channels. Presentations represented a variety of approaches, including drug, biological, and device-based therapeutics. This summary provides high-level summaries of the trials presented and the resulting discussions including lessons learned. Rather than recapitulating published data, the presentations and discussions emphasized the novelty and strengths of each trial, practical aspects of translation, and lessons learned. Throughout the day, several discussion themes surfaced. These included reflections on the suitability of outcome measures and the distinction between statistically or clinically meaningful effects and meaningful changes in quality of life. Additional topics included novel trial designs, selection of inclusion criteria, recognizing the indispensable role of rehabilitation, tailoring approaches to individual needs, the importance of integrating lived experience, and emphasizing the importance of establishing robust pre-clinical data packages before venturing into clinical translation. Importantly, strategic directives are summarized to address these challenges, focusing resources and efforts to steer forthcoming trials effectively.https://www.liebertpub.com/doi/10.1089/neur.2024.0163biologicscellular therapyclinical trialselectrical stimulationneurorestorationnovel trial design |
| spellingShingle | Bethany R. Kondiles Sabhya Rana David Weiner Armin Blesch James St. John Cornelia Haag-Molkenteller Patrick Freund James Guest Daniel D. Mikol Susan Harkema Randy D. Trumbower Michael G. Fehlings Norbert Weidner Gary S. Hogge Edelle C. Field-Fote Marco A.S. Baptista Armin Curt Jane Hsieh Linda Jones Lessons Learned and Recommendations from a SCOPE Spinal Cord Injury Neurorestorative Clinical Trials Update Neurotrauma Reports biologics cellular therapy clinical trials electrical stimulation neurorestoration novel trial design |
| title | Lessons Learned and Recommendations from a SCOPE Spinal Cord Injury Neurorestorative Clinical Trials Update |
| title_full | Lessons Learned and Recommendations from a SCOPE Spinal Cord Injury Neurorestorative Clinical Trials Update |
| title_fullStr | Lessons Learned and Recommendations from a SCOPE Spinal Cord Injury Neurorestorative Clinical Trials Update |
| title_full_unstemmed | Lessons Learned and Recommendations from a SCOPE Spinal Cord Injury Neurorestorative Clinical Trials Update |
| title_short | Lessons Learned and Recommendations from a SCOPE Spinal Cord Injury Neurorestorative Clinical Trials Update |
| title_sort | lessons learned and recommendations from a scope spinal cord injury neurorestorative clinical trials update |
| topic | biologics cellular therapy clinical trials electrical stimulation neurorestoration novel trial design |
| url | https://www.liebertpub.com/doi/10.1089/neur.2024.0163 |
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