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Types of Epilepsy & Seizure Disorders in Children | NYU Langone Health
Specialists at Hassenfeld Children’s Hospital at NYU Langone treat children with different types of epilepsy and seizure disorders.
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A Prospective Randomized Double-Blind Sham-Controlled Multi-Center Pivotal Study to Evaluate the Efficacy and Safety of Duodenal Mucosal Resurfacing Using the Revita System in Subjects with Type 2 Diabetes on Insulin therapy
The Revita® System is an endoscopic treatment consisting of a single catheter and console designed to lift the duodenal mucosa with saline followed by controlled circumferential hydrothermal ablation of the mucosa.The exclusion of the duodenum from the passage of nutrients by surgical diversion appears to result in weight-independent improvements in glycemia associated with a reduction in insulin resistance. This effect is also notable in being almost immediate in its onset (within days) and durable over time (years). The gastrointestinal tract is now recognized to be the largest endocrine organ in the body. It releases gastrointestinal hormones in a finely tuned pattern to help the body achieve glucose homeostasis in the fasting and post-prandial states, with the gastro-intestinal mucosa playing the role as a critical sensing and secreting interface. Bypass of the proximal small bowel appears to modify the secretion of certain key gastrointestinal hormones that in turn lead to improvements in glucose homeostasis. This occurs without calorie malabsorption. Rather, these changes restore the ability of the liver to suppress endogenous glucose production in response to insulin, a physiologic process that is otherwise impaired in diabetes.There are two main theories on how the bypass of the proximal small bowel exerts such a strong anti-diabetic effect, both of which may explain the role of the small bowel in glucose homeostasis.29 First, some believe that the delivery of excess nutrients to the distal small bowel leads to enhanced secretion of GLP-1 (and perhaps additional related insulin-secreting hormones) from the GLP-1-rich entero-endocrine cells of the terminal ileum. Enhanced GLP-1 release into the bloodstream after an ingested meal has a number of beneficial effects on glucose homeostasis30.A second theory is that individuals with Type 2 Diabetes acquire mucosal alterations in their proximal small bowel that contribute to insulin resistance and glucose intolerance and that bypass of this segment is beneficial. Data from rats and humans suggest that prolonged exposure to a Western diet leads to an increase in enteroendocrine cell numbers and a subsequent gastric inhibitory peptide (GIP) after a meal.Other studies have demonstrated hypertrophy of the mucosa of the small bowel in subjects with diabetes.In this way, the insulin resistance of the body may arise from hormones produced by the proximal small bowel as a consequence of these mucosal alterations. The hypothesis is that bypass of the duodenum by nutrients prevents the release of these hormones and therefore immediately leads to an improvement in glucose tolerance after surgery.Moreover, it is now becoming increasingly recognized that the upstream surgical perturbation of the gastrointestinal tract, resulting in the exclusion of the duodenum, does indeed manifest a compelling anti-diabetic effect but the diabetes state of the patient is also a key determinant of outcome. Studies have now reported that the potency of the anti-diabetic effect manifested with metabolic surgery is contingent on or influenced by innate endogenous beta-cell reserve or insulin secretory capacity. In other words, surgery elicits powerful anti-diabetic effects but more notably in the presence of sufficient endogenous beta-cell secretory capacity. This raises important questions concerning a more targeted use of such interventions in individuals that have certain beta-cell reserve characteristics and/or certain companion pharmacological agents that augment beta-cell secretory function (e.g. GLP-1-receptor agonists) to best optimize outcome.A model of type 2 diabetes pathogenesis emerges from these observations. Namely, a life of excess fat and sugar ingestion in genetically prone individuals can lead to changes in the mucosa of the proximal small bowel. These mucosal changes, in turn, are associated with alterations in signals emanating from the proximal gut (including hormone secretion). This altered proximal gut signal exerts an effect that worsens insulin resistance, could negatively affect insulin secretion and may well drive the pathogenesis of T2D. In this context, duodenal exclusion through surgery or a medical device may reduce the abnormal signal emanating from the proximal gut, and thus improves glucose homeostasis.Duodenal mucosal resurfacing (DMR), using the Revita® System, is designed to mimic the metabolic benefit of the duodenal exclusion component of bariatric surgery, thereby eliciting an insulin-sensitizing effect. Duodenal Mucosal Resurfacing (DMR) consists of a highly controlled mucosal lift and ablation procedure of the post papillary duodenum using the Revita® System over the guided wire placed using a standard endoscope.The Revita® clinical data indicates that DMR exerts insulin-sensitizing like effects as evidenced by a lowering of HOMA-IR40, by an insulin-sensitizing metabolic signature by metabolomics testing (e.g., lowering of a-hydroxybutyrate, diacylglycerol, and peroxidase activity), and by other related insulin-sensitizing biomarker effects (including lowered hepatic transaminases and urinary microalbumin).Unlike bariatric surgery, which involves an anatomical bypass of the duodenum and therefore no exposure of ingested nutrients to the surface of that portion of the GI tract, DMR is designed to ablate and re-epithelialize the duodenal mucosal surface, thus allowing nutrients to be exposed to a newly regrown and normalized local mucosa. This infers that the duodenal mucosa surface is in some way abnormal in insulin resistant T2D subjects and is, therefore, emanating a potential ‘insulin resisting’ effect. This notion is supported by multiple lines of evidence: the duodenum undergoes a maladaptive hypertrophic response when exposed to unhealthy nutrients (i.e., fat, simple sugars); this change appears to be associated with an augmented insulin-resistant signal emanating from this portion of the bowel.This signal appears to be persistent and reversible in T2D, as revealed in post-bariatric surgery: in those individuals in whom metabolic improvement has been established after surgery, the acute re-exposure of the bypassed duodenum to nutrients quickly restores the insulin resistant, hyperglycemic, dysmetabolic condition that had existed pre-surgery ; and ablation technology applied to other tissue surfaces has shown that the natural tissue response to ablation is re-growth of a healthy tissue surface.Taken together, there is a strong rationale that the duodenal mucosa of T2D subjects is abnormal and that subjects would likely reap a metabolic benefit if the local duodenal mucosa is resurfaced through an ablation technique.In addition to the glycemic benefits previously seen, data has also indicated liver benefits after ablating abnormal duodenal mucosa in T2D. The C-20000 study, which did not require a NAFLD diagnosis at baseline, showed that approximately 85% of patients had fatty liver even in the presence of normal liver transaminases, confirming prior evidence of the growing epidemiologic overlap with T2D.Patients with NAFLD (liver MRI-PDFF > 5%)at baseline showed a large magnitude and a clinically meaningful reduction in liver fat content at week 12, confirming earlier findings of reductions in ALT through 2 years. These data provide insight into a potential therapeutic opportunity for DMR to favorably impact both T2D and NAFLD/NASH in a manner that can modify the natural history of these chronic and progressive diseases.
Open-Label Multicenter Phase 1 Study to Assess the Safety of P-CD19CD20-ALLO1 in Subjects with Selected Relapsed/Refractory B cell Malignancies
This Phase 1, multi-center, open-label, dose escalation study will enroll and treat approximately 120 adult subjects with relapsed/refractory DLBCL NOS (including DLBCL arising from indolent lymphomas), HGBL, PMBCL, and tFL or follicular lymphoma Grade 3B.This study consists of 2 parts: dose escalation (Part 1) and expansion at a selected dose (= MTD or RDE) and LD regimen (Part 2).Only sites that are experienced in managing oncology subjects and stem-cell/bone marrow transplant and have the resources to manage the types of acute emergent events expected with CAR-T cell administration will be selected to participate in this study. A Safety Committee will meet regularly to review safety data throughout the study.Part 1 (Dose Escalation)During Part 1, dose levels shown in Table 1 will be evaluated using a 3+3 escalation design.Subjects and cohorts will be staggered as follows:• The dosing of the first 3 subjects in all cohorts in Arm S will be staggered by a minimum of 28 days.• There will be a minimum 28-day stagger period between dose escalation cohorts in Arm S.• Dosing in Arms LD 750 and LD 1000 will be = the maximum cleared P-CD19CD20-ALLO1 dose level in Arm S and may enroll concurrently.• The first 2 subjects in Arms LD 750 and LD 1000 at each P-CD19CD20-ALLO1 dose level will be staggered by a minimum of 14 days.The Safety Committee will review the data for each dose cohort to determine progression to the next dose cohort. The Safety Committee may recommend enrollment of additional subjects in a dose cohort of an Arm to further evaluate the outcomes observed at that dose level.The first 3 subjects in each cohort in Arm S must be admitted to the hospital for P-CD19CD20-ALLO1 administration for 7 days. Subjects should remain within 2 hours driving distance from the hospital through 28 days after administration of P-CD19CD20-ALLO1 to attend clinic visits.Dose Escalation GuidelinesThe 3+3 dose escalation will be conducted per Table 2, with the Safety Committee reviewing the data from each dose cohort to determine the outcome. Beginning with Cohort 1 of Arm S (LD regimen of cyclophosphamide (500 mg/m2) and fludarabine (30 mg/m2) and P-CD19CD20-ALLO1 dose of 0.75 × 106 cells/kg), at least 3 subjects will be dosed in the cohort. If no DLT through Day 28 is observed in the first 3 subjects, then dose escalation may proceed to Cohort 2 of Arm S (LD regimen of cyclophosphamide (500 mg/m2) and fludarabine (30 mg/m2) and P-CD19CD20-ALLO1 dose of 2 × 106 cells/kg). Concurrently, Arm LD 750 and Arm LD 1000 may begin enrolling at the cleared Cohort 1 P-CD19CD20-ALLO1 dose of 0.75 × 106 cells/kg.If a DLT is observed in 1 of the first 3 subjects in any Cohort of Arm S, then at least 3 additional subjects will be treated at this dose level. If no further DLT is observed, dose escalation may proceed. If DLTs are observed in 2 or more of 6 subjects, the MTD will be considered to be at the next lower dose level and further enrollment may take place at a lower dose level, or an intermediate dose level may be tested at the discretion of the Safety Committee. If 2 or more subjects experience DLTs in Cohort 1, the Safety Committee, after reviewing available data, may elect to dose 3 subjects in either Cohort minus 1 or Cohort minus 2 with the same 3+3 expansion rules. If 2 or more subjects experience DLTs in Cohort minus 1, the Safety Committee, based on the consideration of safety and efficacy data to assess risk vs. benefit, may elect to dose 3 subjects at a lower dose (Cohort minus 2) with the same 3+3 expansion rules or recommend study discontinuation.If a DLT is observed in 1 of the first 3 subjects in any Cohort of Arm LD 750 or Arm LD 1000, then at least 3 additional subjects will be treated at this dose level and LD regimen. If no further DLT is observed, dose escalation may proceed as P-CD19CD20-ALLO1 dose levels are cleared in Arm S. If DLTs are observed in 2 or more of 6 subjects, the MTD will be considered to be at the next lower P-CD19CD20-ALLO1 dose level and further enrollment may take place at a lower dose level, or an intermediate dose level may be tested at the discretion of the Safety Committee. If 2 or more subjects experience DLTs in Cohort 1, the Safety Committee, after reviewing available data, may elect to dose 3 subjects in either Cohort minus 1 or Cohort minus 2 with the same 3+3 expansion rules. If 2 or more subjects experience DLTs in Cohort minus 1, the Safety Committee, based on the consideration of safety and efficacy data to assess risk vs. benefit, may elect to dose 3 subjects at a lower dose (Cohort minus 2) with the same 3+3 expansion rules or recommend discontinuation of the study Arm.If Cohort 5 is completed in any Arm without identifying an MTD, the Safety Committee may elect to select recommended dose(s) for expansion (RDE) based on established safe doses in Part 1. The Safety Committee may also assess further dose escalation cohorts in increments of 5 to 10 × 106 P-CD19CD20-ALLO1 cells/kg beyond the Cohort 5 dose level. Dose escalation beyond Cohort 5 will proceed only following protocol amendment.Part 2 (Expansion)In Part 2, safety and efficacy data will be monitored at regular intervals throughout the study by the Sponsor medical monitor and Safety Committee to ensure subjects safety.Part 2 will include a population of subjects with B cell malignancies selected based on results from Part 1 and may include one or more of the histologic subtypes of Part 1. Criteria for tumor selection will be based on safety and emerging efficacy observed in Part 1.Subjects in Part 2 will receive P-CD19CD20-ALLO1 at selected dose(s) and LD chemotherapy regimen(s) from Part 1 that were deemed safe based on the safety data, and available PK data, as well as available response data, as determined by the Sponsor. Up to 2 dose levels may be identified from Part 1 for the Part 2 dose expansion. A dose level where no more than 1 of 6 subjects experienced DLTs in Part 1 may continue evaluation with additional subject enrollment for Part 2 if the review of safety, PK, and available response data warrants its expansion. This additional subject enrollment may proceed, while other subjects are undergoing the DLT evaluation period at higher dose levels in Part 1.The Safety Committee and the Sponsor will review all available safety, PK, and/or response data to evaluate the dose(s) in the expansion cohort for selection of the recommended Phase 2 dose (RP2D). An additional 10 subjects may be enrolled at the selected RP2D. In addition, based on discussion with the Safety Committee, other B cell malignancies, such as indolent lymphomas or chronic lymphocytic leukemia (CLL), may also be considered to be evaluated in a separate cohort at documented safe dose(s) from Part 1; up to 20 subjects may be enrolled.