TOKYO & MOUNTAIN VIEW, Calif.--(BUSINESS WIRE)--The SanBio Group (SanBio Co., Ltd. of Tokyo, Japan , SanBio, Inc. of Mountain View, California, US, and SanBio Asia Pte. Ltd. of Singapore) (TOKYO:4592), hereby announce that data comparing outcome measures for persons with traumatic brain injury (TBI) living with chronic motor deficits was published in Expert Review of Neurotherapeutics.
Success in clinical trials in chronic TBI is challenging to define and measure; therefore, this publication is an important advancement for the field of research as it relates to the assessment of persons with motor deficits resulting from a TBI, said Michael A. McCrea, Co-Director, Center For Neurotrauma Research; Professor, Department Of Neurosurgery, Medical College Of Wisconsin, Milwaukee, USA; and lead author for the publication. This study supports the use of Disability Rating Scale (DRS) and Fugl-Meyer Motor Scale (FMMS) in the evaluation of long-term functional outcomes and motor impairment in future clinical trials of persons with chronic motor deficits secondary to TBI.
While acute TBI is widely assessed using Extended Glasgow Outcome Scale (GOS-E), this scale is less well-defined for persons who have chronic, or long-term, motor deficits as a result of their injury. The publication, entitled, Determining minimally clinically important differences (MCIDs) for outcome measures in patients with chronic motor deficits secondary to traumatic brain injury, determined MCIDs for DRS and FMMS. MCID is defined as the smallest change on a measure that is reliably associated with a meaningful change in a patient's clinical status, function, or quality of life.
Establishing MCIDs for the DRS and FMMS in chronic TBI provides improved precision for assessing long-term functional outcomes and motor impairment, respectively, as compared to the widely used GOS-E Scale, which is most appropriate for use in acute TBI. The findings of this study support the use of DRS and Fugl-Meyer Scales in the evaluation of clinical outcomes, and define the amplitude of clinically meaningful improvement for future chronic TBI clinical trials.
At SanBio, we are passionate about improving the lives of persons living with long-term motor deficits as a result of a TBI or stroke. This publication will help to overcome one of the most challenging areas of clinical research: determining the minimal improvement that would be clinically meaningful in patients with chronic motor deficit. We would like to extend our gratitude to the physicians and rehabilitation specialists who supported this important work, added, Bijan Nejadnik, M.D., Corporate Officer, Chief Medical Officer and Head of Research.
This retrospective analysis is from SanBios 1-year, double-blind, randomized, surgical sham-controlled, Phase 2 STEM cell therapy for TRAumatic brain injury (STEMTRA) trial (NCT02416492), in which persons with chronic motor deficits secondary to TBI (n=61) underwent intracerebral stereotactic implantation of SB623 or sham surgery. MCIDs for DRS and FMMS were triangulated with anchor-based, distribution-based, and Delphi panel estimates. The published Delphi panel results are available here. The MCIDs for DRS and FMMS were: 1) 1.5 points for the Disability Rating Scale; 2) 6.2 points for the Fugl-Meyer Upper Extremity Subscale; 3) 3.2 points for the Fugl-Meyer Lower Extremity Subscale; and 4) 8.4 points for the Fugl-Meyer Motor Scale in persons with chronic motor deficits secondary to TBI.
The full publication can be accessed here.
About the STEM cell therapy for TRAumatic brain injury (STEMTRA) Trial
STEMTRA was a 12-month, Phase 2, randomized, double-blind, surgical sham-controlled, global trial evaluating the efficacy and safety of SB623 compared to sham surgery in patients with stable chronic neurological motor deficits secondary to TBI (https://clinicaltrials.gov identifier: NCT02416492). In this study, SB623 cells were implanted directly around the site of brain injury. The primary endpoint was mean change from baseline in FMMS score at six months to measure changes in motor impairment.
To be eligible for this trial, patients (ages 18-75) must have been at least 12 months post-TBI and had a Glasgow Outcome Scale extended (GOS-E) score of 3-6 (e.g., moderate or severe disability). The STEMTRA trial treated 61 patients from 27 sites in the U.S., Japan and Ukraine.
In this study, SB623 met its primary endpoint, with patients treated with SB623 achieving an average 8.3-point improvement from baseline in the FMMS, versus 2.3-points in the control group, at 6 months (p=0.040). No new safety signals were identified, and the most commonly reported adverse event was headaches. The Group, based on the study results, aims to apply for manufacture and marketing approval for SB623 as a regenerative medicine product by utilizing Japans conditional and time-limited approval system for regenerative medicine products.
About Traumatic Brain Injury
Traumatic brain injury (TBI) is one of the leading causes of death and disability worldwide. The estimated global incidence of acute TBI during 2016 was 27 million cases, and the estimated global prevalence of chronic impairment secondary to TBI was 55.5 million cases. Overall, TBI and long-term motor deficits secondary to TBI significantly impair persons self-care, employability, and quality of life, and are major burdens on healthcare systems worldwide. In the United States, approximately 43% of surviving hospitalized persons with TBI experience long-term motor deficits, with 5.3 million people estimated to live with long-term motor deficits secondary to TBI.
About SB623
SB623 is a proprietary, cell-based investigational product made from allogeneic modified and cultured adult bone marrow-derived mesenchymal stem cells (MSCs) that undergo temporary genetic modification. Implantation of SB623 cells into injured nerve tissue in the brain is expected to trigger the brains natural regenerative ability to recover lost motor functions. SanBio is preparing to file a Biologics License Application with the Pharmaceuticals and Medical Devices Agency in Japan for SB623 for the treatment of chronic motor deficits resulting from TBI with STEMTRA results.
About SanBio Group (SanBio Co., Ltd., SanBio, Inc. and SanBio Asia Pte. Ltd.)
SanBio Group is engaged in the regenerative cell medicine business, spanning research, development, manufacture, and sales of regenerative cell medicines. The Companys propriety regenerative cell medicine product, SB623, is currently being investigated for the treatment of several conditions including chronic neurological motor deficit resulting from traumatic brain injury and stroke. The Company is headquartered in Tokyo, Japan, Mountain View, California, US, and SanBio Asia Pte. Ltd. of Singapore), and additional information about SanBio Group is available at https://sanbio.com/en/
Sources: Alves, et al, Why Does Brain Trauma Research Fail? World Neurosurg. (2019) 130:115-121. Selassie AW, et al. Incidence of long-term disability following traumatic brain injury hospitalization, U.S., 2003. J Head Trauma Rehabil 2008;23:123-31. James SL, et al. Global, regional, and national burden of traumatic brain injury and spinal cord injury, 1990-2016: a systematic analysis for the Global Burden of Disease Study 2016. Lancet Neurol 2019;18:56-87. Walker WC & Pickett TC. Motor impairment after severe traumatic brain injury: a longitudinal multicenter study. J Rehabil Res Dev 2007;44:975-82.
Read the original:
SanBio Announces Publication Comparing Outcome Measures for Persons With Chronic Traumatic Brain Injury in Expert Review of Neurotherapeutics -...
- Hyperbaric Chamber Therapy Brain Injury - May 7th, 2011 [May 7th, 2011]
- Treatment for Traumatic Brain Injury - May 9th, 2011 [May 9th, 2011]
- Atlanta Traumatic Brain Injury Treatment Emory - May 11th, 2011 [May 11th, 2011]
- Hyperbaric Oxygen Therapy Brain Injury Part 2 (Tbi) - May 20th, 2011 [May 20th, 2011]
- Mark, anoxi brain injury, physical therapy after stem cell treatment - May 21st, 2011 [May 21st, 2011]
- Hyperbaric Oxygen Therapy - May 21st, 2011 [May 21st, 2011]
- Bob Hahn Traumatic Brain Injury Recovery - May 23rd, 2011 [May 23rd, 2011]
- Mark, anoxi brain injury, after stem cell treatment at Tiantan Puhua Hospital Beijing - May 24th, 2011 [May 24th, 2011]
- New Beginnings community center for brain injury rehabilitation - May 30th, 2011 [May 30th, 2011]
- Traumatic Brain Injury - Part 1 - Dr. Robert Kohn, Neurologist - June 2nd, 2011 [June 2nd, 2011]
- Am I Brain Damaged? from traumatic brain injury - June 3rd, 2011 [June 3rd, 2011]
- SLI Wellness Center for Brain Injury Rehabilitation - June 11th, 2011 [June 11th, 2011]
- Update on Libya, Radiation in Japan, Tramatic Brain Injury treatment and more, 03/23/2011 - June 12th, 2011 [June 12th, 2011]
- Origami Brain Injury Rehabilitation Center - Finding Your Path - June 12th, 2011 [June 12th, 2011]
- Traumatic Brain Injury - Part 5 - Doctor Kohn, Chicago Neurologist - June 16th, 2011 [June 16th, 2011]
- The struggle to treat traumatic brain injury - June 17th, 2011 [June 17th, 2011]
- Traumatic Brain Injury Survivor Speaks about ProTECT trial at UC Health University Hospital - June 17th, 2011 [June 17th, 2011]
- Stem cell treatment for Brain Injury of Adrian - June 23rd, 2011 [June 23rd, 2011]
- Division of Vocational Rehabilitation Services for Traumatic Brain Injury (TBI) - June 24th, 2011 [June 24th, 2011]
- Hyperbaric Chamber Treatment Stroke and Traumatic Brain Injury TBI - July 4th, 2011 [July 4th, 2011]
- Traumatic Brain Injury - Part 2 - Dr. Robert Kohn, Neurologist - July 6th, 2011 [July 6th, 2011]
- Traumatic Brain Injury - Part 7 - Doctor Kohn, MD, Neurology, Neuropsychiatry - July 14th, 2011 [July 14th, 2011]
- Neurofeedback Training and Treatment at Healing Unleashed in Denver Colorado - July 15th, 2011 [July 15th, 2011]
- Alexis Verzal takes independent steps - July 18th, 2011 [July 18th, 2011]
- The New WalkAide System: Advanced Functional Electrical Stimulation (FES) for Treatment of Foot Drop - July 18th, 2011 [July 18th, 2011]
- Doctors Cool Newborn to Limit Brain Damage - July 19th, 2011 [July 19th, 2011]
- Traumatic Brain Injury - Part 6 - by Neurologist, Dr. Robert Kohn - July 24th, 2011 [July 24th, 2011]
- Brain injury and trauma treatment by homeopathy - July 31st, 2011 [July 31st, 2011]
- Traumatic Brain Injury - Part 4 - Dr. Kohn, Neuropsychiatrist / Neurologist - August 9th, 2011 [August 9th, 2011]
- Preserving Hope, Predicting Health - August 17th, 2011 [August 17th, 2011]
- Sask Brain Injury Association - August 19th, 2011 [August 19th, 2011]
- Cognition and Mild Head Injury by Dr. Muriel Lezak - August 21st, 2011 [August 21st, 2011]
- Brain injury_Shawna_ USA_before stem cell treatment 1.wmv - August 25th, 2011 [August 25th, 2011]
- Origami Brain Injury Rehabilitation Center - Recovery is a Journey - August 26th, 2011 [August 26th, 2011]
- Different types of Concussions by Dr. James Chesnutt.mov - August 30th, 2011 [August 30th, 2011]
- Brain injury_Shawna_ USA_after stem cell treatment 1.wmv - September 11th, 2011 [September 11th, 2011]
- With Brain Injuries, Soldiers Face A Battle For Care - September 23rd, 2011 [September 23rd, 2011]
- Tripler Medical Center Treats Traumatic Brain Injury (TBI) - September 24th, 2011 [September 24th, 2011]
- Sessions' Traumatic Brain Injury Amendment to DOD Appropriations - October 2nd, 2011 [October 2nd, 2011]
- Using Stem Cells for Treatment of TBI | Dr. Charles Cox | Research Trials - October 5th, 2011 [October 5th, 2011]
- Healing brain injuries - October 8th, 2011 [October 8th, 2011]
- Veterans Services at Origami Brain Injury Rehabilitation Center - - October 8th, 2011 [October 8th, 2011]
- Hope Beyond Trauma - October 9th, 2011 [October 9th, 2011]
- Traumatic Brain Injury - Part 3 - by Neurologist Dr. Robert Kohn - October 10th, 2011 [October 10th, 2011]
- Understanding and Improving Vocational Outcomes following Traumatic Brain Injury - Video - October 16th, 2011 [October 16th, 2011]
- LI facility dedicated to Terri Schiavo - Video - October 17th, 2011 [October 17th, 2011]
- Treating Traumatic Brain Injury with Neurotopia - featuring Holden McCray - October 18th, 2011 [October 18th, 2011]
- Brain Injury Survivors: Adriana Villar (Making a Difference: Story 1) - Video - October 21st, 2011 [October 21st, 2011]
- Fabio - brain injury - Video - October 23rd, 2011 [October 23rd, 2011]
- The Latest Developments in Traumatic Brain Injury Treatment - Video - October 25th, 2011 [October 25th, 2011]
- Stem Cell Treatments and Brain Damage Video of MRI of Brain Chambers WWW.STEMCELLREGENMED.COM - Video - October 29th, 2011 [October 29th, 2011]
- Military lags on promising treatment for brain-injured soldiers - Video - November 6th, 2011 [November 6th, 2011]
- Brian Moylan (TBI survivor) talking on treatment from the NHS - Video - November 10th, 2011 [November 10th, 2011]
- Brain Injury Experts at Madonna Rehabilitation Hospital - Video - November 12th, 2011 [November 12th, 2011]
- H200 Hand Rehabilitation System - Testimonials - Clinical Focus - Video - November 13th, 2011 [November 13th, 2011]
- Coping with Brain Injury: Robots and Rehabilitation - Video - November 16th, 2011 [November 16th, 2011]
- Traumatic Brain Injury Rehabilitation using MediTouch HandTutor - Video - November 18th, 2011 [November 18th, 2011]
- Brain Injury Treatment Success | College Station Chiropractor Dr. David Bailey - Video - November 30th, 2011 [November 30th, 2011]
- Hyperbaric Oxygen Therapy (HBOT) corrects brain-injury. - Video - December 7th, 2011 [December 7th, 2011]
- Story of a Traumatic Brain Injury Recovery with Hyperbaric Oxygen (Part1/4) - Video - December 8th, 2011 [December 8th, 2011]
- Hyperbaric Oxygen Therapy Brain Injury - Video - December 10th, 2011 [December 10th, 2011]
- Redwood Extended Care Facility - Brain Injury Services - Video - December 10th, 2011 [December 10th, 2011]
- What If... Brain Injury Rehabilitation - Video - December 17th, 2011 [December 17th, 2011]
- Dangers in Self Medication - Young Adults with Lyme Disease - Leo J. Shea, III, PhD - Video - December 18th, 2011 [December 18th, 2011]
- Reducing Severe Traumatic Brain Injury in the US - Video - December 19th, 2011 [December 19th, 2011]
- Traumatic Brain Injury - Part 8 - Dr. R. Kohn, MD, Neurology - December 21st, 2011 [December 21st, 2011]
- Brain injury rehabilitation using Wii recreational therapy - Video - December 24th, 2011 [December 24th, 2011]
- CNS President/CEO Dr. Mark Ashley discusses how research shapes brain injury rehabilitation - Video - December 29th, 2011 [December 29th, 2011]
- Albert James De Meillon-Traumatic Brain Injury-Part 1 - Video - January 1st, 2012 [January 1st, 2012]
- Hope Beyond Trauma_Janie Smith - Video - January 10th, 2012 [January 10th, 2012]
- Neurofeedback adhd - Video - January 11th, 2012 [January 11th, 2012]
- We are the World, We ARE The Children - Video - January 11th, 2012 [January 11th, 2012]
- New Hopes for Treating Traumatic Brain Injury - Video - January 11th, 2012 [January 11th, 2012]
- NeuroRestorative's Robin Ray Featured on ABC in Southern Illinois - Video - January 13th, 2012 [January 13th, 2012]
- Careers at Origami Brain Injury Rehabilitation Center - Video - January 26th, 2012 [January 26th, 2012]
- Chris Persel discusses what makes CNS a leader in brain injury rehabilitation - Video - January 27th, 2012 [January 27th, 2012]
- Care for catastrophic injuries, spinal cord and traumatic brain injury - Video - January 27th, 2012 [January 27th, 2012]
- Military Tests Pressurized Chamber to Treat TBI - Video - January 27th, 2012 [January 27th, 2012]
- Richmond Traumatic Brain Injury Attorneys Applaud White House Research Initiative Targeting Veterans’ Health Issues - January 28th, 2012 [January 28th, 2012]
- Protect Your Brain...Why? - Video - January 30th, 2012 [January 30th, 2012]