The Cell and Gene Therapy Consortium's Perspective on Harmonizing Data Collection for Patient Enrollment, Therapy Ordering and Scheduling, and Cell Collection.

Established in October 2021, the Cell and Gene Therapy (CGT) Consortium convened with the goal to bring together key CGT stakeholders - manufacturers, treatment centers, regulators, services providers, and ecosystem partners - to gain alignment on process definitions, terminology, challenges, and opportunities for process and data standardization from CGT program start-up and patient enrollment to therapy administration. With the recognition that the number of investigational and commercial cell and gene therapies will scale over the next several years, so will the number of manufacturer-specific processes and solutions (e.g.

A Design Tool for Solar Thermal Remediation Using Borehole Heat Exchangers.

Low temperature heating of the subsurface (increases of about 5-20 °C) can substantially increase rates of biotic and abiotic destruction of dissolved contaminants such as chlorinated solvents. Low-temperature heating can be sustainably and cost-effectively achieved using solar thermal collectors coupled with closed-loop borehole heat exchangers. This technology has been implemented at several sites in the United States and abroad with favorable results.

Characterization of per- and polyfluoroalkyl substances on fire suppression system piping and optimization of removal methods.

Fire suppression systems are known to be impacted with residual, entrained per- and polyfluoroalkyl substances (PFASs) because of historical use of aqueous film forming foam (AFFF) and fluoroprotein foam. Amphiphilic PFASs aggregate at liquid:solid interfaces creating a hydrophobic layer which reduces the effectiveness of water to remove PFAS from layered surfaces. When fire suppression systems are transitioned to fluorine free foam (F3) without appropriate cleaning, residual PFASs associated with the surfaces of the fire suppression system can contaminate the replacement F3.

Are We Making PROGRESS in Preventing Graft-versus-Host Disease and Improving Clinical Outcomes? Impact of BMT CTN 1301 Study Results on Clinical Practice.

The need for prospective randomized clinical trials investigating novel graft-versus-host disease (GVHD) prevention strategies that include other clinical outcomes impacted by GVHD has been highlighted as a priority for the field of hematopoietic cell transplantation. A recently completed study through the Blood and Marrow Transplant Clinical Trials Network (BMT CTN 1301) comparing CD34 selection and post-transplantation cyclophosphamide with tacrolimus/methotrexate (Tac/MTX) for GVHD prevention demonstrated no significant differences in the primary endpoint of chronic GVHD relapse-free survival among the 3 approaches. The trial did not demonstrate a superior approach compared with Tac/MTX; however, it did highlight several challenges in determining the best and most relevant approaches to clinical trial design, particularly in the context of current and ongoing changes in real-world practices.

Socioeconomic and Racial Disparity in Chimeric Antigen Receptor T Cell Therapy Access.

Chimeric antigen receptor (CAR) T cell therapy is changing the paradigm in hematologic malignancies, but disparities in access exist in the real-world setting. Efforts to address and eliminate these disparities will ensure availability of this life-saving therapy. This study aimed to determine patterns of racial/ethnic distribution, socioeconomic strata, insurance coverage, and travel time of CAR T cell recipients.

Impact of SARS-CoV-2 in Hematopoietic Stem Cell Transplantation and Chimeric Antigen Receptor T Cell Therapy Recipients.

Coronavirus disease 2019 (COVID-19), a respiratory illness caused by the novel severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), was declared a pandemic in March 2020, and has caused more than 600,000 deaths in the United States at the time of this report. Hematopoietic stem cell transplantation (HCT) or chimeric antigen receptor T cell (CAR-T) therapy recipients have a higher risk of mortality with COVID-19 owing to profound immune dysregulation. In this study, we investigated the impact of SARS-CoV-2 in HCT/CAR-T therapy recipients.

Economic and Clinical Burden of Virus-Associated Hemorrhagic Cystitis in Patients Following Allogeneic Hematopoietic Stem Cell Transplantation in the United States.

Hemorrhagic cystitis (HC) caused by viral infections such as BK virus, cytomegalovirus, and/or adenovirus after allogeneic hematopoietic stem cell transplantation (allo-HCT) causes morbidity and mortality, affects quality of life, and poses a substantial burden to the health care system. At present, HC management is purely supportive, as there are no approved or recommended antivirals for virus-associated HC. The objective of this retrospective observational study was to compare the economic burden, health resource utilization (HRU), and clinical outcomes among allo-HCT recipients with virus-associated HC to those without virus-associated HC using a large US claims database.

Strategic resources for assessing PFAS ecological risks at AFFF sites.

The use of aqueous film forming foam (AFFF) in the United States has caused concern about the potential effects of per- and polyfluoroalkyl substances (PFAS) on ecological resources. Moreover, the limited availability of scientific information and a lack of guidance have collectively resulted in significant challenges for ecological risk assessors supporting site-specific investigations and management decisions at PFAS-impacted sites. To address these needs, the environmental science and technology program of the Department of Defense (DoD), the Strategic Environmental Research and Development Program (SERDP), began funding four desktop review projects in 2018.

Design, testing, and implementation of a real-time system for monitoring flow in horizontal wells.

The Horizontal Reactive Media Treatment Well (HRX Well®) is a technology capable of collecting and treating groundwater passively. To monitor the internal flow rate, ensuring it remains at an acceptable level and maintains the desired capture zone size in the aquifer, Point Velocity Probes (PVPs) were adapted for the task. The modified PVP was assessed for its performance in a mock-HRX Well setting, which consisted of a laboratory sand column, similar in diameter to the HRX Well cartridges that would house the PVP in the field, with flow directed along the longitudinal axis of the probe.

Development of Per and Polyfluoroalkyl Substances Ecological Risk-Based Screening Levels.

Evaluation of chemical risks to threatened and endangered species is a requirement for Superfund ecological risk assessments; however, screening levels to evaluate the potential for toxicity associated with ecological receptor exposure to per- and polyfluoroalkyl substances (PFAS) are lacking. Therefore, PFAS risk-based screening levels (RBSLs) were developed. Wildlife RBSLs were developed using surrogate receptors selected to be representative of threatened and endangered species with different habitat types, feeding guilds, and trophic levels.

Acute myeloid leukemia or myelodysplastic syndrome with chromosome 17 abnormalities and long-term outcomes with or without hematopoietic stem cell transplantation.

Introduction: Chromosome 17 abnormalities, especially disorders of the 17p region and including TP53 gene mutations, result in very low rates of cure for patients with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) treated with conventional chemotherapy or allogeneic hematopoietic cell transplant (allo-HCT). Our retrospective study analyzed outcomes in patients with chromosome 17 (ch17) abnormalities who received conventional chemotherapy followed by allo-HCT versus those who did not receive a transplant. We analyzed whether poor outcomes extend to patients with all types of ch17 abnormalities and the impact of concomitant TP53 gene mutations assessed by next-generation sequencing (NGS) on prognosis.

Health Care Reimbursement, Service Utilization, and Outcomes among Medicare Beneficiaries with Multiple Myeloma Receiving Autologous Hematopoietic Cell Transplantation in Inpatient and Outpatient Settings.

Autologous hematopoietic stem cell transplantation (auto-HCT) is a complex procedure that can be performed in both inpatient (IP) and outpatient (OP) care settings. We examined reimbursement, service utilization, and patient financial responsibility among Medicare beneficiaries with multiple myeloma who underwent auto-HCT in the IP and OP settings using a merged dataset of the Center for International Blood and Marrow Transplant Research observational database and Centers for Medicare & Medicaid Services Medicare administrative claims data. Selection criteria included first auto-HCT, time from diagnosis to auto-HCT <18 months, and continuous enrollment in Medicare Parts A and B for 30 days before HCT index claims and 100 days post-HCT or until death.

[Is the medication reconciliation achievable and relevant in Psychiatry?: Feedback on the implementation of medication reconciliation on hospital admission].

Objective: The health care pathway of patients suffering from mental disorders is complex and includes a risk of interruption of treatment. We implemented medication reconciliation at patients' admission to mental health care service in February 2017. The aim of this study was to achieve a feedback experience answering our questions about the feasibility and relevance of this process.

Results of the First Clinical Study in Humans That Combines Hyperbaric Oxygen Pretreatment with Autologous Peripheral Blood Stem Cell Transplantation.

Patients undergoing high-dose chemotherapy and autologous hematopoietic cell transplantation (auto-HCT) are at risk for multiple morbidities, including mucosal inflammation and neutropenic fever, both related to neutropenia. Evidence from our preclinical work in an umbilical cord blood (UCB) transplantation murine model suggests that treatment with hyperbaric oxygen (HBO) before UCB infusion improves UCB CD34 cell engraftment by reducing erythropoietin levels. A pilot clinical trial using HBO in patients undergoing UCB transplantation showed improvement in kinetics of blood count recovery.

Evaluation of Performance Status and Hematopoietic Cell Transplantation Specific Comorbidity Index on Unplanned Admission Rates in Patients with Multiple Myeloma Undergoing Outpatient Autologous Stem Cell Transplantation.

Although outpatient autologous stem cell transplantation (ASCT) is safe and feasible in most instances, some patients undergoing planned outpatient transplantation for multiple myeloma (MM) will need inpatient admission for transplantation-related complications. We aim to evaluate the difference, if any, between outpatient and inpatient ASCT cohorts of MM patients in terms of admission rate, transplantation outcome, and overall survival. We also plan to assess whether the Hematopoietic Cell Transplantation Comorbidity Index (HCT-CI) and Karnofsky Performance Status (KPS) can predict unplanned admissions after adjusting for confounding factors.

Wharton's Jelly-Derived Mesenchymal Stromal Cells as a Promising Cellular Therapeutic Strategy for the Management of Graft-versus-Host Disease.

Allogeneic hematopoietic cell transplantation (allo-HCT), a treatment option in hematologic malignancies and bone marrow failure syndromes, is frequently complicated by Graft-versus-host disease (GVHD). The primary treatment for GVHD involves immune suppression by glucocorticoids. However, patients are often refractory to the steroid therapy, and this results in a poor prognosis.

Prophylactic use of zoledronic acid to prevent early bone loss is safe and feasible in patients with acute myeloid leukemia undergoing allogeneic stem cell transplantation.

Osteopenia and osteoporosis are well-known consequences of allogeneic stem cell transplantation (allo-SCT). The role of prophylactic zoledronic acid on bone turnover following allo-SCT has not been well characterized. We prospectively studied the role of prophylactic use of zoledronic acid on bone metabolism in 17 patients with acute myeloid leukemia (AML) undergoing allo-SCT over a period of three yr (2006-2009).

Ethyl glucuronide for detecting alcohol lapses in patients with an alcohol use disorder.

Urine ethyl glucuronide (EtG) was screened in 75 patients during a hospital-based treatment for an alcohol use disorder. During follow-up, EtG was detected in 35 (14.6%) of the 239 urine samples.