Translation of immunomodulatory therapy to treat chronic heart failure: Preclinical studies to first in human.

Background: Inflammation has been associated with progression and complications of chronic heart failure (HF) but no effective therapy has yet been identified to treat this dysregulated immunologic state. The selective cytopheretic device (SCD) provides extracorporeal autologous cell processing to lessen the burden of inflammatory activity of circulating leukocytes of the innate immunologic system.

Aim: The objective of this study was to evaluate the effects of the SCD as an extracorporeal immunomodulatory device on the immune dysregulated state of HF.

Understanding factors that contribute to the disposal of unused opioid medication.

Purpose: Drivers of excess controlled substance disposal behaviors are not well understood. A survey of patients who had received opioid-based medications was conducted to inform the design of future innovative drug take-back programs.

Methods: This was a cross-sectional survey study conducted in 152 participants who received treatment with an opioid within the previous 2 years and had possession of unused medication following either switching to a different opioid or discontinuation of pain.

Regenerative Medicine and Immunomodulatory Therapy: Insights From the Kidney, Heart, Brain, and Lung.

Regenerative medicine was initially focused on tissue engineering to replace damaged tissues and organs with constructs derived from cells and biomaterials. More recently, this field of inquiry has expanded into exciting areas of translational medicine modulating the body's own endogenous processes, to prevent tissue damage in organs and to repair and regenerate these damaged tissues. This review will focus on recent insights derived from studies in which the manipulation of the innate immunologic system may diminish acute kidney injury and enhance renal repair and recovery without the progression to chronic kidney disease and renal failure.

Novel Leukocyte Modulator Device Reduces the Inflammatory Response to Cardiopulmonary Bypass.

Leukocyte (LE) activation during cardiopulmonary bypass (CPB) promotes a systemic inflammatory response that contributes to organ injury and postoperative organ dysfunction. A leukocyte modulatory device (L-MOD) for use during (and after) CPB to limit leukocyte-mediated organ injury was tested in a preclinical model. Twenty-two pigs underwent 180 minutes of CPB and 5 hours postoperative observation.

White Paper AGA: An Episode-of-Care Framework for the Management of Obesity-Moving Toward High Value, High Quality Care: A Report From the American Gastroenterological Association Institute Obesity Episode of Care and Bundle Initiative Work Group.

The American Gastroenterological Association acknowledges the need for gastroenterologists to participate in and provide value-based care for both cognitive and procedural conditions. Episodes of care are designed to engage specialists in the movement toward fee for value, while facilitating improved outcomes and patient experience and a reduction in unnecessary services and overall costs. The episode of care model puts the patient at the center of all activity related to their particular diagnosis, procedure, or health care event, rather than on a physician's specific services.

Bioengineered Renal Cell Therapy Device for Clinical Translation.

The bioartificial renal epithelial cell system (BRECS) is a cell-based device to treat acute kidney injury through renal cell therapy from an extracorporeal circuit. To enable widespread implementation of cell therapy, the BRECS was designed to be cryopreserved as a complete device, cryostored, cryoshipped to an end-use site, thawed as a complete device, and employed in a therapeutic extracorporeal hemofiltration circuit. This strategy overcomes storage and distribution issues that have been previous barriers to cell therapy.

Development of a wearable bioartificial kidney using the Bioartificial Renal Epithelial Cell System (BRECS).

Cell therapy for the treatment of renal failure in the acute setting has proved successful, with therapeutic impact, yet development of a sustainable, portable bioartificial kidney for treatment of chronic renal failure has yet to be realized. Challenges in maintaining an anticoagulated blood circuit, the typical platform for solute clearance and support of the biological components, have posed a major hurdle in advancement of this technology. This group has developed a Bioartificial Renal Epithelial Cell System (BRECS) capable of differentiated renal cell function while sustained by body fluids other than blood.

An Immunomodulatory Device Improves Insulin Resistance in Obese Porcine Model of Metabolic Syndrome.

Obesity is associated with tissue inflammation which is a crucial etiology of insulin resistance. This inflammation centers around circulating monocytes which form proinflammatory adipose tissue macrophages (ATM). Specific approaches targeting monocytes/ATM may improve insulin resistance without the adverse side effects of generalized immunosuppression.

Immunomodulatory Device Promotes a Shift of Circulating Monocytes to a Less Inflammatory Phenotype in Chronic Hemodialysis Patients.

Patients with end-stage renal disease (ESRD) on chronic hemodialysis (HD) suffer accelerated morbidity and mortality rates caused by cardiovascular disease and infections. Chronic inflammation plays a critical role in these poor outcomes. The activated monocyte (MO) has become a prime therapeutic target to modulate this inflammatory process.

Evaluation of Pharmacists' Work in a Physician-Pharmacist Collaborative Model for the Management of Hypertension.

Study Objective: Physician-pharmacist collaborative models have been shown to improve the care of patients with numerous chronic medical conditions. Team-based health care using integrated clinical pharmacists provides one opportunity to improve quality in health care systems that use population-based financing. In November 2015, the Centers for Medicare and Medicaid Services (CMS) requested that the relative value of pharmacists' work in team-based care needs to be established.

Negating Tissue Contracture Improves Volume Maintenance and Longevity of In Vivo Engineered Tissues.

Background: Engineering large, complex tissues in vivo requires robust vascularization to optimize survival, growth, and function. Previously, the authors used a "chamber" model that promotes intense angiogenesis in vivo as a platform for functional three-dimensional muscle and renal engineering. A silicone membrane used to define the structure and to contain the constructs is successful in the short term.

A bio-artificial renal epithelial cell system conveys survival advantage in a porcine model of septic shock.

Renal cell therapy using the hollow fiber based renal assist device (RAD) improved survival time in an animal model of septic shock (SS) through the amelioration of cardiac and vascular dysfunction. Safety and ability of the RAD to improve clinical outcomes was demonstrated in a Phase II clinical trial, in which patients had high prevalence of sepsis. Even with these promising results, clinical delivery of cell therapy is hampered by manufacturing hurdles, including cell sourcing, large-scale device manufacture, storage and delivery.

The bioartificial kidney.

Renal failure has an exceedingly high mortality rate despite advances in dialysis technology. Current renal replacement therapies (RRTs) restore only the filtration function of the kidney. Replacing the critical transport, metabolic, and endocrine functions of the kidney may provide more complete RRT, changing the natural history of these disease processes.

The bioartificial kidney: current status and future promise.

The rapid understanding of the cellular and molecular bases of organ function and disease processes will be translated in the next decade into new therapeutic approaches to a wide range of clinical disorders, including acute and chronic renal failure. Central to these new therapies are the developing technologies of cell therapy and tissue engineering, which are based on the ability to expand stem or progenitor cells in tissue culture to perform differentiated tasks and to introduce these cells into the patient either via extracorporeal circuits or as implantable constructs. Cell therapy devices are currently being developed to replace the filtrative, metabolic, and endocrinologic functions of the kidney lost in both acute and chronic renal failure.

Cell-based approaches for the treatment of systemic inflammation.

Acute and chronic solid organ failures are costly disease processes with high mortality rates. Inflammation plays a central role in both acute and chronic organ failure, including heart, lung and kidney. In this regard, new therapies for these disorders have focused on inhibiting the mediators of inflammation, including cytokines and free radicals, with little or no success in clinical studies.

Selective cytopheretic inhibitory device with regional citrate anticoagulation and portable sorbent dialysis.

Selective cytopheretic inhibitory device (SCD) therapy is an immunomodulatory treatment provided by a synthetic biomimetic membrane in an extracorporeal circuit, which has shown promise in preclinical large animal models of severe sepsis as well as in clinical trials treating patients with acute kidney injury and multiple organ failure. During SCD therapy, citrate is administered to lower ionized calcium levels in blood for anticoagulation and inhibition of leukocyte activation. Historically, citrate has been known to interfere with sorbent dialysis, therefore, posing a potential issue for the use of SCD therapy with a portable dialysis system.

Enhanced propagation of adult human renal epithelial progenitor cells to improve cell sourcing for tissue-engineered therapeutic devices for renal diseases.

Renal cell therapy employing cells derived from adult renal epithelial cell (REC) progenitors promises to reduce the morbidity of patients with renal insufficiency due to acute renal failure and end stage renal disease. To this end, tissue engineered devices addressing the neglected biologic component of renal replacement therapy are being developed. Because human donor tissue is limited, novel enhanced progenitor cell propagation (EP) techniques have been developed and applied to adult human kidney transplant discards from six donors.

A selective cytopheretic inhibitory device for use during cardiopulmonary bypass surgery.

Background: Systemic inflammatory response syndrome (SIRS) can occur in association with cardiopulmonary bypass (CPB) surgery, resulting in multiple organ dysfunction (MOD). Activated neutrophils have been implicated as major inciting factors in this process. Neutrophil-depleting filters incorporated within the extracorporeal blood circuit during CPB have been developed and evaluated, with inconsistent clinical results.

Bioartificial Renal Epithelial Cell System (BRECS): A Compact, Cryopreservable Extracorporeal Renal Replacement Device.

Renal cell therapy has shown clinical efficacy in the treatment of acute renal failure (ARF) and promise for treatment of end-stage renal disease (ESRD) by supplementing conventional small solute clearance (hemodialysis or hemofiltration) with endocrine and metabolic function provided by cells maintained in an extracorporeal circuit. A major obstacle in the widespread adoption of this therapeutic approach is the lack of a cryopreservable system to enable distribution, storage, and therapeutic use at point of care facilities. This report details the design, fabrication, and assessment of a Bioartificial Renal Epithelial Cell System (BRECS), the first all-in-one culture vessel, cryostorage device, and cell therapy delivery system.

Racetalk and sport: the color consciousness of contemporary discourse on basketball.

This article explores how a sample of college students discursively negotiated perceptions of race and ability in the context of mediated sport. A majority of respondents expressed acceptance of a link between racial identity and sport-specific skills. However, rather than articulate this notion overtly and directly, rhetorical strategies, such as disclaimers and coded language, were used.

A biomimetic membrane device that modulates the excessive inflammatory response to sepsis.

Objective: Septic shock has a clinical mortality rate approaching fifty percent. The major clinical manifestations of sepsis are due to the dysregulation of the host's response to infection rather than the direct consequences of the invading pathogen. Central to this initial immunologic response is the activation of leukocytes and microvascular endothelium resulting in cardiovascular instability, lung injury and renal dysfunction.

Cell therapy in kidney failure.

Current therapy for acute renal failure continues to have an exceedingly high mortality rate, exceeding 50% even with dialytic or hemofiltrative support. Current renal replacement therapy in ARF only substitutes for filtration function of the kidney but not its cellular metabolic functions. Replacing these metabolic functions may optimize current therapy for this devastating disease process.

CPT code-change proposal: national data on pharmacists' medication therapy management services.

The objectives of this article are to provide a brief history of progress toward attaining CPT codes for medication therapy management (MTM) services, review progress made by PSTAC toward obtaining CPT reporting and billing codes for pharmacists' clinical services, and present results from national provider and payer surveys submitted to the CPT Editorial Panel in conjunction with a Category I CPT code-change proposal for MTM services.

Future of medication therapy management services in delivering patient-centered care.

Purpose: The scope of medication therapy management services (MTMS) is defined, opportunities for pharmacists to influence change in the pharmacy profession by embracing MTMS, current challenges in providing MTMS, possible solutions to these challenges, and the tipping point that MTMS represents to the pharmacy profession are discussed.

Summary: Pharmacist services include a spectrum of activities involving face-to-face interaction between a pharmacist and a patient to improve health outcomes, and MTMS is at the high end of this spectrum. MTMS can be provided to fee-for-service and managed care patients as well as to Medicare Part D enrollees.