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Treating amyotrophic lateral sclerosis with allogeneic Schwann cell-derived exosomal vesicles: a case report

Neural Regeneration Research 2025年第4期20卷 1207-1216页

作者： Pascal J.Goldschmidt-Clermont Aisha Khan George Jimsheleishvili Patricia Graham Adriana Brooks Risset Silvera Alexander J.P.Goldschmidt Damien D.Pearse W.Dalton Dietrich Allan D.Levi James D.Guest miller school of medicine University of MiamiMiamiFLUSA Stem Cell Institute Miller School of MedicineUniversity of MiamiMiamiFLUSA The miami Project to Cure Paralysis Miller School of MedicineUniversity of MiamiMiamiFLUSA Alzady International LLC MiamiFLUSA Neurological Surgery Miller School of MedicineUniversity of MiamiMiamiFLUSA

Schwann cells are essential for the maintenance and function of motor neurons,axonal networks,and the neuromuscular junction.In amyotrophic lateral sclerosis,where motor neuron function is progressively lost,Schwann cell function may also be impaired.Recently,important signaling and potential trophic activities of Schwann cell-derived exosomal vesicles have been reported.This case report describes the treatment of a patient with advanced amyotrophic lateral sclerosis using serial intravenous infusions of allogeneic Schwann cell-derived exosomal vesicles,marking,to our knowledge,the first instance of such treatment.An 81-year-old male patient presented with a 1.5-year history of rapidly progressive amyotrophic lateral sclerosis.After initial diagnosis,the patient underwent a combination of generic riluzole,sodium phenylbutyrate for the treatment of amyotrophic lateral sclerosis,and taurursodiol.The patient volunteered to participate in an FDA-approved single-patient expanded access treatment and received weekly intravenous infusions of allogeneic Schwann cell-derived exosomal vesicles to potentially restore impaired Schwann cell and motor neuron function.We confirmed that cultured Schwann cells obtained from the amyotrophic lateral sclerosis patient via sural nerve biopsy appeared impaired(senescent)and that exposure of the patient’s Schwann cells to allogeneic Schwann cell-derived exosomal vesicles,cultured expanded from a cadaver donor improved their growth capacity in vitro.After a period of observation lasting 10 weeks,during which amyotrophic lateral sclerosis Functional Rating Scale-Revised and pulmonary function were regularly monitored,the patient received weekly consecutive infusions of 1.54×1012(×2),and then consecutive infusions of 7.5×1012(×6)allogeneic Schwann cell-derived exosomal vesicles diluted in 40 mL of Dulbecco’s phosphate-buffered saline.None of the infusions were associated with adverse events such as infusion reactions(allergic or otherwise)or changes in vital signs.Clinical lab serum neuro

关键词： allogeneic amyotrophic lateral sclerosis exosomes infusion neuromuscular junction Schwann cell

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Recent advancements in noninvasive brain modulation for individuals with autism spectrum disorder

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Neural Regeneration Research 2023年第6期18卷 1191-1195页

作者： Jessica R.Griff Jake Langlie Nathalie B.Bencie Zachary J.Cromar Jeenu Mittal Idil Memis Steven Wallace Alexander E.Marcillo Rahul Mittal Adrien A.Eshraghi Hearing Research and Communication Disorders Laboratory Department of OtolaryngologyNeurotology DivisionUniversity of Miami Miller School of MedicineMiamiFLUSA Department of Neurological Surgery University of Miami Miller School of MedicineMiamiFLUSA Department of Biomedical Engineering University of MiamiCoral GablesFLUSA Department of Pediatrics University of Miami Miller School of MedicineMiamiFLUSA

Autism spectrum disorder is classified as a spectrum of neurodevelopmental disorders with an unknown definitive etiology.Individuals with autism spectrum disorder show deficits in a variety of areas including cognition,memory,attention,emotion recognition,and social skills.With no definitive treatment or cure,the main interventions for individuals with autism spectrum disorder are based on behavioral modulations.Recently,noninvasive brain modulation techniques including repetitive transcranial magnetic stimulation,intermittent theta burst stimulation,continuous theta burst stimulation,and transcranial direct current stimulation have been studied for their therapeutic properties of modifying neuroplasticity,particularly in individuals with autism spectrum disorder.Preliminary evidence from small cohort studies,pilot studies,and clinical trials suggests that the various noninvasive brain stimulation techniques have therapeutic benefits for treating both behavioral and cognitive manifestations of autism spectrum disorder.However,little data is available for quantifying the clinical significance of these findings as well as the long-term outcomes of individuals with autism spectrum disorder who underwent transcranial stimulation.The objective of this review is to highlight the most recent advancements in the application of noninvasive brain modulation technology in individuals with autism spectrum disorder.

关键词： autism spectrum disorder behavior cognition neurostimulation interventions noninvasive brain modulation theta burst stimulation transcranial direct current stimulation transcranial magnetic stimulation

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Macrophage depletion and Schwann cell transplantation reduce cyst size after rat contusive spinal cord injury

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Neural Regeneration Research 2018年第4期13卷 684-691页

作者： Yee-Shuan Lee Lucy H.Funk Jae K.Lee Mary Bartlett Bunge The miami Project to Cure Paralysis University of Miami Miller School of Medicine Department of Neurological Surgery University of Miami Miller School of Medicine Department of Cell Biology University of Miami Miller School of Medicine

Schwann cell transplantation is a promising therapy for the treatment of spinal cord injury（SCI） and is currently in clinical trials.In our continuing efforts to improve Schwann cell transplantation strategies,we sought to determine the combined effects of Schwann cell transplantation with macrophage depletion.Since macrophages are major inflammatory contributors to the acute spinal cord injury,and are the major phagocytic cells,we hypothesized that transplanting Schwann cells after macrophage depletion will improve cell survival and integration with host tissue after SCI.To test this hypothesis,rat models of contusive SCI at thoracic level 8 were randomly subjected to macrophage depletion or not.In rat subjected to macrophage depletion,liposomes filled with clodronate were intraperitoneally injected at 1,3,6,11,and 18 days post injury.Rats not subjected to macrophage depletion were intraperitoneally injected with liposomes filled with phosphate buffered saline.Schwann cells were transplanted 1 week post injury in all rats.Biotinylated dextran amine（BDA） was injected at thoracic level 5 to evalute axon regeneration.The Basso,Beattie,and Bresnahan locomotor test,Gridwalk test,and sensory test using von Frey filaments were performed to assess functional recovery.Immunohistochemistry was used to detect glial fibrillary acidic protein,neurofilament,and green fluorescent protein（GFP）,and also to visulize BDA-labelled axons.The GFP labeled Schwann cell and cyst and lesion volumes were quantified using stained slides.The numbers of BDA-positive axons were also quantified.At 8 weeks after Schwann cell transplantation,there was a significant reduction in cyst and lesion volumes in the combined treatment group compared to Schwann cell transplantation alone.These changes were not associated,however,with improved Schwann cell survival,axon growth,or locomotor recovery.Although combining Schwann cell transplantation with macrophage depletion does improve histopathology of the injury site,the effect on axon growth and behavior

关键词： Schwann cell Iiposome clodrosome clodronate axon regeneration Schwann cell survival neuroprotection glial scar cyst cell transplantation

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Exploring the role of interleukin-27 as a regulator of neuronal survival in central nervous system diseases

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Neural Regeneration Research 2022年第10期17卷 2149-2152页

作者： Andrea N.Nortey Kimberly N.Garces Abigail S.Hackam Bascom Palmer Eye Institute University of Miami Miller School of MedicineMiamiFLUSA

Interleukin-27 is a pleiotropic cytokine that is involved in tissue responses to infection,cell stress,neuronal disease,and tumors.Recent studies in various tissues indicate that interleukin-27 has complex activating and inhibitory properties in innate and acquired immunity.The availability of recombinant interleukin-27 protein and mice with genetic deletions of interleukin-27,its receptors and signaling mediators have helped define the role of interleukin-27 in neurodegenerative diseases.Interleukin-27 has been well-characterized as an important regulator of T cell activation and differentiation that enhances or suppresses T cell responses in autoimmune conditions in the central nervous system.Evidence is also accumulating that interleukin-27 has neuroprotective activities in the retina and brain.Interleukin-27 is secreted from and binds to infiltrating microglia,macrophage,astrocytes,and even neurons and it promotes neuronal survival by regulating pro-and anti-inflammatory cytokines,neuroinflammatory pathways,oxidative stress,apoptosis,autophagy,and epigenetic modifications.However,interleukin-27 can have the opposite effect and induce inflammation and cell death in certain situations.In this review,we describe the current understanding of regulatory activities of interleukin-27 on cell survival and inflammation and discuss its mechanisms of action in the brain,spinal cord,and retina.We also review evidence for and against the therapeutic potential of interleukin-27 for dampening harmful neuroinflammatory responses in central nervous system diseases.

关键词： central nervous system cytokine inflammatory interleukin-27 neuroprotection retina

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Neuronal and endothelial transglutaminase-2 expression in experimental autoimmune encephalomyelitis and multiple sclerosis

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Neural Regeneration Research 2022年第7期17卷 1471-1472页

作者： Damien D.Pearse Mousumi Ghosh miami Project to Cure Paralysis University of Miami Miller School of MedicineMiamiFLUSA Department of Neurological Surgery University of Miami Miller School of MedicineMiamiFLUSA Neuroscience Program Interdisciplinary Stem Cell InstituteUniversity of Miami Miller School of MedicineMiamiFLUSA Department of Veterans Affairs Veterans Affairs Medical CenterMiamiFLUSA

Multiple sclerosis(MS)is a neurological condition characterized by the disruption of the blood-brain barrier,immune system activation,and infla mmation that is accompanied by glial reactivity,neuronal cell death,axon demyelination,and axotomy.Pathological changes result in functional loss including paralysis,migraine,vision problems,spasticity,and neuropathic pain.

关键词： sclerosis paralysis autoimmune

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Unraveling pathological mechanisms in neurological disorders:the impact of cell-based and organoid models

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Neural Regeneration Research 2022年第10期17卷 2131-2140页

作者： Jake Langlie Rahul Mittal Ariel Finberg Nathalie B.Bencie Jeenu Mittal Hossein Omidian Yadollah Omidi Adrien A.Eshraghi Department of Otolaryngology Hearing Research and Communication Disorders LaboratoryUniversity of Miami Miller School of MedicineMiamiFLUSA College of Pharmacy Nova Southeastern UniversityFort LauderdaleFLUSA Department of Neurological Surgery University of Miami Miller School of MedicineMiamiFLUSA Department of Biomedical Engineering University of MiamiCoral GablesFLUSA Department of Pediatrics University of Miami Miller School of MedicineMiamiFLUSA

Cell-based models are a promising tool in deciphering the molecular mechanisms underlying the pathogenesis of neurological disorders as well as aiding in the discovery and development of future drug therapies.The greatest challenge is creating cell-based models that encapsulate the vast phenotypic presentations as well as the underlying genotypic etiology of these conditions.In this article,we discuss the recent advancements in cell-based models for understanding the pathophysiology of neurological disorders.We reviewed studies discussing the progression of cell-based models to the advancement of three-dimensional models and organoids that provide a more accurate model of the pathophysiology of neurological disorders in vivo.The better we understand how to create more precise models of the neurological system,the sooner we will be able to create patient-specific models and large libraries of these neurological disorders.While three-dimensional models can be used to discover the linking factors to connect the varying phenotypes,such models will also help to understand the early pathophysiology of these neurological disorders and how they are affected by their environment.The three-dimensional cell models will allow us to create more specific treatments and uncover potentially preventative measures in neurological disorders such as autism spectrum disorder,Parkinson’s disease,Alzheimer’s disease,and amyotrophic lateral sclerosis.

关键词： Alzheimer’s disease amyotrophic lateral sclerosis autism spectrum disorder cell-based model central nervous system induced pluripotent stem cells mesenchymal stem cells organoid model organ-on-a-chip Parkinson’s disease three-dimensional model

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Human neural stem cell transplants to address multiple pathologies associated with traumatic brain injury

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Neural Regeneration Research 2019年第10期14卷 1699-1700页

作者： Helene Clervius Mirza Baig Anil Mahavadi Shyam Gajavelli University of Miami Miller School of Medicine

Traumatic brain injury (TBI), an unmet need: TBI is an alteration in brain function caused by an external force with evidence of brain pathology. It could be from a bump, blow, blast or jolt to the head including penetrating the cranium. TBI is a public health concern worldwide due to its economic impact. Most TBIs are survivable, do not need hospitalization but may influence productivity. A smaller percentage of TBI due to falls or penetrating TBI (PTBI) needs hospitalization and accounts for largest fraction of TBI care costs.

关键词： Traumatic brain injury(TBI) function caused by an external largest fraction of TBI care costs

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Does being female provide a neuroprotective advantage following spinal cord injury?

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Neural Regeneration Research 2015年第10期10卷 1533-1536页

作者： Jeffrey P.Datto Jackie Yang W.Dalton Dietrich Damien D.Pearse The miami Project to Cure Paralysis University of Miami Miller School of Medicine The Department of Neurological Surgery University of Miami Miller School of Medicine The Department of Neurology University of Miami Miller School of Medicine The Department of Cell Biology University of Miami Miller School of Medicine The Neuroscience Program University of Miami Miller School of Medicine The Interdisciplinary Stem Cell Institute University of Miami Miller School of Medicine

It has been controversial whether gender has any effect on recovery following spinal cord injury（SCI）. Past experimental and clinical research aimed at addressing this subject has led to constrasting findings on whether females hold any advantage in locomotor recovery. Additionally, for studies supporting the notion of a female gender related advantage, a definite cause has not been explained. In a recent study, using large sample sizes for comparative male and female spinal cord injury cohorts, we reported that a significant gender advantage favoring females existed in both tissue preservation and functional recovery after taking into consideration discrepancies in age and weight of the animals across sexes. Prior animal research frequently used sample sizes that were too small to determine significance with certainty and also did not account for two other factors that influence locomotor performance： age and weight. Our finding is important in light of controversy surrounding the effect of gender on outcome and the fact that SCI affects more than ten thousand new individuals annually, a population that is disproportionately male. By deepening our understanding of why a gender advantage exists, potential new therapeutics can be designed to improve recovery for the male population following the initial trauma or putatively augment the neuroprotective privilege in females for enhanced outcomes.

关键词： sex gender hormone neuroprotection estrogen progesterone apoptosis Schwann cell

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Endoscopic management of adolescent closed Cowper’s gland syringocele with holmium:YAG laser

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Asian Journal of Urology 2022年第3期9卷 340-342页

作者： Maria F.Becerra Nicholas Smith Abhishek Bhat Hemendra N.Shah Department of Urology Miller School of MedicineUniversity of MiamiMiamiFLUSA

Dear editor,The term“syringocele”originated from Greek words“syringo”meaning tube and“cele”meaning swelling and was first coined by Maizels et al.[1]in 1983 to represent a spectrum of dilatation of the normal Cowper’s gland duct.They classified syringocele into four morphological types:Simple,perforate,imperforate,and ruptured.Melquist et al.[2]simplified the classification by dividing syringocele into two groups:Closed and open syringocele.Usually diagnosed in the pediatric population,only 10 cases of adult syringocele were reported in literature till 2007[3].Endoscopic management is preferred in most symptomatic adolescent patients and various energy sources employed for endoscopic marsupialization include cold knife urethrotomy,electrocautery,or holmium laser[4,5].Use of holmium laser is reported only in three cases with maximum follow-up of up to 1 year[6e8].We herein report three additional cases of adolescent closed syringocele,provide detailed technique of laser marsupialization,and report its long-term postoperative outcome.The study was approved by the university of miami Ethics Committee(study ID:20180511).

关键词： laser dividing swelling

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Immunity Genes and Susceptibility to Otitis Media:A Comprehensive Review

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Journal of Genetics and Genomics 2014年第11期41卷 567-581页

作者： Rahul Mittal Giannina Robalino Robert Gerring Brandon Chan Denise Yan M'hamed Grati Xue-Zhong Liu Department of Otolaryngology University of Miami Miller School of Medicine Department of Human Genetics University of Miami Miller School of Medicine Department of Biochemistry University of Miami Miller School of Medicine

Otitis media （OM） is a middle ear infection associated with inflammation and pain. This disease frequently afflicts humans and is the major cause of hearing loss worldwide. OM continues to be one of the most challenging diseases in the medical field due to its diverse host targets and wide range of clinical manifestations. Substantial morbidity associated with OM is further exacerbated by high frequency of recurrent infections leading to chronic suppurative otitis media （CSOM）. Children have greater susceptibility to, and thus, suffer most frequently from OM, which can cause significant deterioration in quality of life. Genetic factors have been demonstrated, in large part by twin and family studies, to be key determinants of OM susceptibility. In this review, we summarize the current knowledge on immunity genes and selected variants that have been associated with predisposition to OM. In particular, polymorphisms in innate immunity and cytokine genes have been strongly linked with the risk of developing OM. Future studies employing state-of-the-art technologies, including next-generation sequencing （NGS）, will aid in the identification of novel genes associated with susceptibility to OM. This, in turn, will open up avenues for identifying high-risk individuals and designing novel therapeutic strategies based on precise targeting of these genes.

关键词： Otitis media Genetics Innate immunity Cytokines

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