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Background: We report the initial results from a phase I clinical trial for ALS. We transplanted GMP-grade, fetal human neural stem cells from natural in utero death (hNSCs) into the anterior horns of the spinal cord to test for the safety of both cells and neurosurgical procedures in these patients. The trial was approved by the Istituto Superiore di Sanità and the competent Ethics Committees and was monitored by an external Safety Board.
Methods: Six non-ambulatory patients were treated. Three of them received 3 unilateral hNSCs microinjections into the lumbar cord tract, while the remaining ones received bilateral (n = 3 + 3) microinjections. None manifested severe adverse events related to the treatment, even though nearly 5 times more cells were injected in the patients receiving bilateral implants and a much milder immune-suppression regimen was used as compared to previous trials.
Results: No increase of disease progression due to the treatment was observed for up to18 months after surgery. Rather, two patients showed a transitory improvement of the subscore ambulation on the ALS-FRS-R scale (from 1 to 2). A third patient showed improvement of the MRC score for tibialis anterior, which persisted for as long as 7 months. The latter and two additional patients refused PEG and invasive ventilation and died 8 months after surgery due to the progression of respiratory failure. The autopsies confirmed that this was related to the evolution of the disease.
Conclusions: We describe a safe cell therapy approach that will allow for the treatment of larger pools of patients for later-phase ALS clinical trials, while warranting good reproducibility. These can now be carried out under more standardized conditions, based on a more homogenous repertoire of clinical grade hNSCs. The use of brain tissue from natural miscarriages eliminates the ethical concerns that may arise from the use of fetal material.
Trial Registration: EudraCT:2009-014484-39 .
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http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4359401 | PMC |
http://dx.doi.org/10.1186/s12967-014-0371-2 | DOI Listing |
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Graduate School of Information Science and Technology, Osaka University, Osaka, Japan.
Not harming others is widely regarded as a fundamental tenet of human morality. Harm aversion based on the consequences of an action is called utilitarianism while focusing on the action itself is associated with deontology. This study investigated how interoceptive processing affects the neural processing of utilitarian and deontological moral decision-making.
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School of Management Engineering and Business, Hebei University of Engineering, Handan, China.
In the rapid urbanization process in China, due to reasons such as employment, education, and family reunification, the number of mobile population without registered residence in the local area has increased significantly. By 2020, the group had a population of 276 million, accounting for over 20% of the total population, making significant contributions to urban economic development and resource optimization. However, the health status of migrant populations is affected by unique issues such as occupational risks and socio-economic disparities, which play an important role in personal welfare, social stability, and sustainable economic growth.
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Department of Dermatology, First Clinical Medical College of Zhejiang Chinese Medical University, Hangzhou, Zhejiang, China.
Background: Psoriatic arthritis (PSA) is an inflammatory joint disease associated with psoriasis (PSO) that can be easily missed. Existing PSA screening tools ignore objective serologic indicators. The aim of this study was to develop a disease screening model and the Psoriatic Arthritis Inflammation Index (PSAII) based on serologic data to enhance the efficiency of PSA screening.
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February 2025
Department of Neuroscience, The Ohio State University Wexner Medical Center, USA.
Chronic stress increases the incidence of psychiatric disorders including anxiety, depression, and posttraumatic stress disorder. Repeated Social Defeat (RSD) in mice recapitulates several key physiological, immune, and behavioral changes evident after chronic stress in humans. For instance, neurons in the prefrontal cortex, amygdala, and hippocampus are involved in the interpretation of and response to fear and threatful stimuli after RSD.
View Article and Find Full Text PDFJ Pathol Inform
January 2025
Department of Pharmaceutics, Center for Pharmacometrics and Systems Pharmacology, Intelligent Critical Care Center, College of Pharmacy, University of Florida, Orlando, FL, USA.
Human islets display a high degree of heterogeneity in terms of size, number, architecture, and endocrine cell-type compositions. An ever-increasing number of immunohistochemistry-stained whole slide images (WSIs) are available through the online pathology database of the Network for Pancreatic Organ donors with Diabetes (nPOD) program at the University of Florida (UF). We aimed to develop an enhanced machine learning-assisted WSI analysis workflow to utilize the nPOD resource for analysis of endocrine cell heterogeneity in the natural history of type 1 diabetes (T1D) in comparison to donors without diabetes.
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