News Article | May 11, 2017
"These new follow-up results based on MRI scans are very encouraging, and strongly suggest that AST-OPC1 cells have engrafted in these patients post-implantation and have the potential to prevent lesion cavity formation, possibly reducing long-term spinal cord tissue deterioration after spinal cord injury," said Dr. Edward Wirth, Chief Medical Officer of Asterias. "Moreover, these new results add to the overall body of data supporting AST-OPC1's safety, and are consistent with safety data from our previous Phase 1 study in thoracic spinal cord injury and our extensive preclinical studies in more than 3,000 animals." Under the study protocol, patients are monitored by MRI scans at regular intervals over 12 months in order to assess status of the injection site and surrounding tissues. The Company will discuss the MRI data in more detail on its first quarter 2017 conference call and webcast on May 11, 2017 at 4:30 p.m. Eastern / 1:30 p.m Pacific. For both "listen-only" participants and those participants who wish to take part in the question-and-answer session, the call can be accessed by dialing 800-533-7619 (U.S./Canada) or 785-830-1923 (international) five minutes prior to the start of the call and providing the Conference ID 7610291. To access the live webcast, go to http://asteriasbiotherapeutics.com/inv_events_presentations.php. The SCiStar trial is an open-label, single-arm trial testing three sequential escalating doses of AST-OPC1 administered at up to 20 million AST-OPC1 cells in as many as 35 patients with sub-acute, C-5 to C-7, motor complete (AIS-A or AIS-B) cervical SCI. These individuals have essentially lost all movement below their injury site and experience severe paralysis of the upper and lower limbs. AIS-A patients have lost all motor and sensory function below their injury site, while AIS-B patients have lost all motor function but may retain some minimal sensory function below their injury site. AST-OPC1 is being administered 14 to 30 days post-injury. Patients will be followed by neurological exams and imaging procedures to assess the safety and activity of the product. The study is being conducted at six centers in the U.S. and the company plans to increase this to up to 12 sites to accommodate the expanded patient enrollment. Clinical sites involved in the study include the Medical College of Wisconsin in Milwaukee, Shepherd Medical Center in Atlanta, University of Southern California (USC) jointly with Rancho Los Amigos National Rehabilitation Center in Los Angeles, Indiana University, Rush University Medical Center in Chicago and Santa Clara Valley Medical Center in San Jose jointly with Stanford University. Asterias has received a Strategic Partnerships Award grant from the California Institute for Regenerative Medicine, which provides $14.3 million of non-dilutive funding for the Phase 1/2a clinical trial and other product development activities for AST-OPC1. Additional information on the Phase 1/2a trial, including trial sites, can be found at www.clinicaltrials.gov, using Identifier NCT02302157, and at the SCiStar Study Website (www.SCiStar-study.com). AST-OPC1, an oligodendrocyte progenitor population derived from human embryonic stem cells, has been shown in animals and in vitro to have three potentially reparative functions that address the complex pathologies observed at the injury site of a spinal cord injury. These activities of AST-OPC1 include production of neurotrophic factors, stimulation of vascularization, and induction of remyelination of denuded axons, all of which are critical for survival, regrowth and conduction of nerve impulses through axons at the injury site. In preclinical animal testing, AST-OPC1 administration led to remyelination of axons, improved hindlimb and forelimb locomotor function, dramatic reductions in injury-related cavitation and significant preservation of myelinated axons traversing the injury site. In a previous Phase 1 clinical trial, five patients with neurologically complete, thoracic spinal cord injury were administered two million AST-OPC1 cells at the spinal cord injury site 7-14 days post-injury. They also received low levels of immunosuppression for the next 60 days. Delivery of AST-OPC1 was successful in all five subjects with no serious adverse events associated with AST-OPC1. No evidence of rejection of AST-OPC1 was observed in detailed immune response monitoring of all patients. In four of the five patients, serial MRI scans indicated that reduced spinal cord cavitation may have occurred. Based on the results of this study, Asterias received clearance from FDA to progress testing of AST-OPC1 to patients with cervical spine injuries, which represents the first targeted population for registration trials. Asterias Biotherapeutics, Inc. is a biotechnology company pioneering the field of regenerative medicine. The company's proprietary cell therapy programs are based on its pluripotent stem cell and immunotherapy platform technologies. Asterias is presently focused on advancing three clinical-stage programs which have the potential to address areas of very high unmet medical need in the fields of neurology and oncology. AST-OPC1 (oligodendrocyte progenitor cells) is currently in a Phase 1/2a dose escalation clinical trial in spinal cord injury. AST-VAC1 (antigen-presenting autologous dendritic cells) is undergoing continuing development by Asterias based on promising efficacy and safety data from a Phase 2 study in Acute Myeloid Leukemia (AML), with current efforts focused on streamlining and modernizing the manufacturing process. AST-VAC2 (antigen-presenting allogeneic dendritic cells) represents a second generation, allogeneic cancer immunotherapy. The company's research partner, Cancer Research UK, plans to begin a Phase 1/2a clinical trial of AST-VAC2 in non-small cell lung cancer in 2017. Additional information about Asterias can be found at www.asteriasbiotherapeutics.com. Statements pertaining to future financial and/or operating and/or clinical research results, future growth in research, technology, clinical development, and potential opportunities for Asterias, along with other statements about the future expectations, beliefs, goals, plans, or prospects expressed by management constitute forward-looking statements. Any statements that are not historical fact (including, but not limited to statements that contain words such as "will," "believes," "plans," "anticipates," "expects," "estimates") should also be considered to be forward-looking statements. Forward-looking statements involve risks and uncertainties, including, without limitation, risks inherent in the development and/or commercialization of potential products, uncertainty in the results of clinical trials or regulatory approvals, need and ability to obtain future capital, and maintenance of intellectual property rights. Actual results may differ materially from the results anticipated in these forward-looking statements and as such should be evaluated together with the many uncertainties that affect the businesses of Asterias, particularly those mentioned in the cautionary statements found in Asterias' filings with the Securities and Exchange Commission. Asterias disclaims any intent or obligation to update these forward-looking statements. To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/new-mri-data-from-asterias-ongoing-scistar-clinical-study-indicates-ast-opc1-cells-prevent-formation-of-damaging-lesion-cavities-in-patients-suffering-severe-spinal-cord-injury-300455768.html
Yoon S.B.,National Rehabilitation Center |
Lee B.S.,National Rehabilitation Center |
Lee K.D.,National Rehabilitation Center |
Hwang S.I.,Soonchunhyang University |
And 2 more authors.
Spinal Cord | Year: 2014
Study design:A one-year epidemiological survey.Objective:To compare bacterial strains and antimicrobial susceptibilities of urinary isolates from hospital and community spinal cord injury (SCI) patients.Setting:A specialized SCI unit in a freestanding rehabilitation hospital.Methods:From June 2012 through May 2013, urine cultures were obtained from all of the newly admitted patients. Bacterial strains and antimicrobial susceptibilities were compared between patients from community and hospital settings.Results:The proportion of Enterobacteriaceae in the total urinary isolates from hospital-dwelling patients was smaller than that from community-dwelling patients (66.0 vs 85.5%, P<0.001), while the proportions of Pseudomonas, Acinetobacter and Enterococcus species were relatively larger (8.7%, 6.0% and 12.0% vs 2.8%, 0.7% and 2.8%, respectively, P<0.05). The isolates from hospital-dwelling patients showed lower susceptibility to ampicillin, amoxicillin-clavulanic acid, trimethoprim-sulfamethoxazole and all generations of cephalosporin (P<0.05), and a higher prevalence of extended-spectrum beta-lactamase (ESBL)-producers (41.7 vs 5.4%, P<0.001), compared with those from community-dwelling patients. The susceptibility rates to levofloxacin were lower than 50% in both community and hospital-dwelling patients.Conclusion:Broader-spectrum antibiotics should be considered in treating nosocomial urinary tract infection (UTI) of SCI patients because of the relatively wide variety of organisms and higher frequency of antibiotic-resistant strains, including ESBL-producing Enterobacteriaceae in hospital-derived specimens. Furthermore, in areas with high prevalence of fluoroquinolone resistance, fluoroquinolones should be used with caution during empirical treatment for UTI in SCI patients. © 2014 International Spinal Cord Society.
Griffiths A.,University College London |
Hill R.,Bethlem and Maudsley Hospital |
Morgan C.,University College London |
Rendell P.G.,Australian Catholic University |
And 4 more authors.
Addiction | Year: 2012
Aim: To assess objectively prospective memory (PM) performance of individuals with alcohol dependence and determine whether the use of an imagery technique at the point of encoding can enhance their performance. Design: An independent group design was used to compare individuals with alcohol dependence with social drinkers. Setting: One UK residential substance misuse service. Participants: Twenty-four abstinent 'individuals with alcohol dependence' and 24 social drinkers matched on age, gender and years of education. Measurements: The virtual week (VW); story recall; a category fluency task; trail-making test (TMT); a single digit cancellation task (SDCT); spot-the-word; State-Trait Anxiety Inventory (STAI); Beck Depression Inventory (BDI-II); and the Severity of Alcohol Dependence Questionnaire (SAD-Q) Findings: Event-based PM task performance of individuals with alcohol dependence was associated strongly with indices of alcohol usage (P<0.001), and was impaired significantly compared to that of social drinkers (P<0.001). Imagining improved social drinkers' time-based PM but not that of individuals with alcohol dependence. Conclusions: Individuals with alcohol dependence may experience prospective memory deficits which may be due to difficulties with effective strategy application. © 2012 The Authors, Addiction © 2012 Society for the Study of Addiction.
An S.,National Rehabilitation Center |
Lee Y.,Dongseo University |
Lee G.,Kyungnam University
Tohoku Journal of Experimental Medicine | Year: 2014
Falling is one of the most common complications in stroke survivors. It is therefore important to evaluate the risk of falls. In this study, we investigated the usability of the performance-oriented mobility assessment (POMA) for predicting falls in stroke patients. The POMA examines the level of balance and mobility. Data were collected on the number of falls and physical functions from 72 stroke survivors. Physical functions were measured using the POMA balance subscale, One Leg Stand test (OLS), Sit To Stand test (STS), 10-m Walk Test (10WT), Fugl-Meyer assessment (FM), and Trunk Impairment Scale (TIS). Since the accuracy of the POMA balance subscale was moderate, the cutoff value used for predicting falls was 12.5 points (sensitivity: 72%; specificity: 74%), and the area under the curve was 0.78 (95% confidence interval: 0.66-0.91, p < 0.001). When comparing the physical functions (i.e., OLS, STS, 10WT, FM, and TIS) to the cutoff value for the POMA balance subscale, the physical functions of the group over 12.5 points for the subscale were significantly higher than those in the group below 12.5 points (p < 0.05). The muscle strength shown in the STS was the most important factor affecting the performance in the POMA balance subscale (β = -0.447). For the group below 12.5 points on the POMA balance subscale, the risk of falling increased by 0.304 times more than the group over 12.5 points. The POMA balance subscale is a valid tool for assessing the physical function and fall risk of stroke survivors. © 2014 Tohoku University Medical Press. © 2014 Tohoku University Medical Press.
Kim S.W.,National Health Insurance Service Ilsan Hospital |
Kim J.H.,National Health Insurance Corporation Ilsan Hospital |
Han Z.-A.,National Rehabilitation Center
Brain Injury | Year: 2013
Background: Intracranial stab wounds are low-velocity, penetrating injuries to the brain and fatality and outcome significantly depend on route, depth and location of cranial penetration. Due to the effective barrier provided by the adult calvarium, most injuries occur through the orbitae or temporal regions where bony layers are thin. Self-inflicted intracranial stab wounds are an even rarer form of traumatic brain injury, with common entry points being the orbital space and the nose. Intracranial brainstem injuries mostly result in death, with reported penetration areas being the pons or midbrain. Case: The following report reviews a first reported case of self-inflicted intracranial stabbing via a trans-oral route with lesions to the medulla oblongata and cerebellum. Unlike previous cases of low velocity penetrating injuries to the brainstem, the patient underwent full neurologic recovery after manual knife removal and intensive rehabilitation. Conclusion: Self-inflicted transcranial injuries have been mentioned only briefly and sporadically in the literature. This article highlights a rare case of self-inflicted intracranial stabbing with a not yet reported entry route and brainstem lesion. Unlike the other fatal outcomes associated with such injuries, the patient underwent full neurological and functional recovery through a comprehensive approach that included intensive rehabilitation. © 2013 Informa UK Ltd. All rights reserved: reproduction in whole or part not permitted.
Kratiras Z.,Koutlibanio General Hospital of Larisa |
Konstantinidis C.,National Rehabilitation Center |
Skriapas K.,Koutlibanio General Hospital of Larisa
International Braz J Urol | Year: 2014
Objectives: To review the literature and present new data of continuous androgen deprivation therapy (ADT) vs intermittent androgen deprivation (IAD) as therapies for prostate cancer in terms of survival and quality of life and clarify practical issues in the use of IAD. Materials and Methods: We conducted a systematic search on Medline and Embase databases using "prostatic neoplasm" and "intermittent androgen deprivation" as search terms. We reviewed meta-analyses, randomised controlled trials, reviews, clinical trials and practise guidelines written in English from 2000 and onwards until 01/04/2013. Ten randomized controlled trials were identified. Seven of them published extensive data and results randomizing 4675 patients to IAD versus CAD. Data from the other three randomized trials were limited. Results: Over the last years studies confirmed that IAD is an effective alternative approach to hormonal deprivation providing simultaneously several potential benefits in terms of quality of life and cost effectiveness. Thus, in patients with non metastatic, advanced prostate cancer IAD could be used as standard treatment, while in metastatic prostate cancer IAD role still remains ambiguous. Conclusions: Nowadays, revaluation of the gold standard of ADT in advanced prostate cancer appears essential. Recent data established that IAD should no longer be considered as investigational, since its effectiveness has been proven, especially in patients suffering from non-metastatic advanced prostate cancer.
Shin J.-H.,National Rehabilitation Center |
Ryu H.,Hanyang University |
Jang S.H.,Hanyang University
Journal of NeuroEngineering and Rehabilitation | Year: 2014
Background: Virtual reality (VR) is not commonly used in clinical rehabilitation, and commercial VR gaming systems may have mixed effects in patients with stroke. Therefore, we developed RehabMaster™, a task-specific interactive game-based VR system for post-stroke rehabilitation of the upper extremities, and assessed its usability and clinical efficacy. Methods. A participatory design and usability tests were carried out for development of RehabMaster with representative user groups. Two clinical trials were then performed. The first was an observational study in which seven patients with chronic stroke received 30 minutes of RehabMaster intervention per day for two weeks. The second was a randomised controlled trial of 16 patients with acute or subacute stroke who received 10 sessions of conventional occupational therapy only (OT-only group) or conventional occupational therapy plus 20 minutes of RehabMaster intervention (RehabMaster + OT group). The Fugl-Meyer Assessment score (FMA), modified Barthel Index (MBI), adverse effects, and drop-out rate were recorded. Results: The requirements of a VR system for stroke rehabilitation were established and incorporated into RehabMaster. The reported advantages from the usability tests were improved attention, the immersive flow experience, and individualised intervention. The first clinical trial showed that the RehabMaster intervention improved the FMA (P =.03) and MBI (P =.04) across evaluation times. The second trial revealed that the addition of RehabMaster intervention tended to enhance the improvement in the FMA (P =.07) but did not affect the improvement in the MBI. One patient with chronic stroke left the trial, and no adverse effects were reported. Conclusions: The RehabMaster is a feasible and safe VR system for enhancing upper extremity function in patients with stroke. © 2014Shin et al.; licensee BioMed Central Ltd.
Yoon S.B.,National Rehabilitation Center
Journal of Rehabilitation Medicine | Year: 2014
Objective: To determine the prevalence of, and risk factors for, highly resistant microorganisms (HRMO) in urinary isolates from newly admitted patients in a rehabilitation hospital.Subjects: A total of 906 patients transferred to a rehabilitation hospital from other hospitals.Methods: A screening study was performed from June 2012 through May 2013. Urine samples were collected from transferred patients on admission day.Results: Of the total of 916 patients, 148 (16.2%) displayed growth of HRMO in urine cultures. Gram-negative species had a higher number and ratio of HRMO compared with Gram-positive species (141/325 (43.4%) vs 9/97 (9.3%)). Multivariate analysis revealed that age over 60 years, female sex, recent surgery, and use of urinary catheters were risk factors for HRMO among all admitted patients. Even among patients with bacteriuria, recent surgery and an indwelling urinary catheter were significant risk factors for HRMO colonization. The odds ratio for prevalence of HRMO in patients with 2 or more risk factors was 4.1 (95% confidence interval 2.7-6.1), compared with those with single or no risk factors.Conclusion: The prevalence of HRMO in rehabilitation patients was higher than expected. Routine screening of urine culture for HRMO is therefore recommended in rehabilitation patients with multiple risk factors. © 2014 The Authors. © 2014 Foundation of Rehabilitation Information.
Kim J.H.,Konkuk University |
Yu H.Y.,National Rehabilitation Center |
Park S.Y.,Seoul National University |
Lee S.C.,Seoul National University |
Kim Y.C.,Seoul National University
Pain Medicine (United States) | Year: 2013
Objectives. Many patients develop dental treatment-related symptomatic trigeminal neuralgia. However, the effectiveness of pulsed radiofrequency (PRF) treatment and conventional radiofrequency thermocoagulation (RFTC) for treatment of this disorder has not been determined. This retrospective study was conducted to compare the effectiveness and complications of PRF and RFTC in these patients. Methods. Fifty-four patients who experienced the onset of symptomatic trigeminal neuralgia after a dental treatment were managed by PRF or RFTC. Data were collected by reviewing their medical records and conducting a questionnaire. Patients' characteristics, the dental procedures that caused the trigeminal neuralgia, the baseline and posttreatment pain intensities, duration of pain relief, complications, and satisfactions to the treatment were evaluated. Results. Pain intensities were lower at 1 week (3.0/10 vs 6.4/10), at 1 month (2.5/10 vs 5.9/10), 3 months (2.6/10 vs 5.5/10), 6 months (3.1/10 vs 7.1/10) and 1 year (4.8/10 vs 7.2/10) in the RFTC group (28 patients) than in the PRF group (26 patients) (P<0.05). The duration of pain relief without medication in the RFTC group (10.8 months) was longer than that in the PRF group (0 months). The incidence of complications in the RFTC group (46.4%) was higher than that in the PRF group (3.8%) (P<0.05). The RFTC group reported higher satisfaction ratings (3.86/5) than the PRF group (2.19/5) (P<0.05). Conclusions. Although the RFTC group had more complications than the PRF group, most were minor and transient, and the patient satisfaction rate with RFTC was very high. Therefore, RFTC is an effective tool for the treatment of dental procedure-induced trigeminal neuralgia. © 2013 American Academy of Pain Medicine.
National Rehabilitation Center | Date: 2015-06-05
The present invention relates to a feeding assistant robot, which assists in feeding patients or the elderly and infirm who have difficulty in moving their arms and thus have difficulty in feeding themselves. The feeding assistant robot includes: a picking arm including a gripper for picking up food placed on a tray; a feeding arm, including a spoon on which the food picked up by the picking arm is placed, for moving the spoon to the mouth of a user; an input device enabling the user to direct the movements of the picking arm and of the feeding arm; and a control unit electrically connected to the picking arm, the feeding arm, and the manipulation part to control the movements of the picking arm and the feeding arm according to the commands from the input device.