Grant List
Represents Grant table in the DB
GET /v1/grants?page%5Bnumber%5D=3&sort=-awardee_organization
{ "links": { "first": "https://cic-apps.datascience.columbia.edu/v1/grants?page%5Bnumber%5D=1&sort=-awardee_organization", "last": "https://cic-apps.datascience.columbia.edu/v1/grants?page%5Bnumber%5D=1392&sort=-awardee_organization", "next": "https://cic-apps.datascience.columbia.edu/v1/grants?page%5Bnumber%5D=4&sort=-awardee_organization", "prev": "https://cic-apps.datascience.columbia.edu/v1/grants?page%5Bnumber%5D=2&sort=-awardee_organization" }, "data": [ { "type": "Grant", "id": "15323", "attributes": { "award_id": "1R24GM154040-01", "title": "DIALS: supporting structural biology through open source diffraction processing software", "funder": { "id": 4, "ror": "https://ror.org/01cwqze88", "name": "National Institutes of Health", "approved": true }, "funder_divisions": [ "National Institute of General Medical Sciences (NIGMS)" ], "program_reference_codes": [], "program_officials": [ { "id": 11852, "first_name": "Anne", "last_name": "Gershenson", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "start_date": "2024-09-20", "end_date": "2029-07-31", "award_amount": 1204713, "principal_investigator": { "id": 31918, "first_name": "Aaron Samuel", "last_name": "Brewster", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] }, "other_investigators": [], "awardee_organization": { "id": 2533, "ror": "", "name": "UNIVERSITY OF CALIF-LAWRENC BERKELEY LAB", "address": "", "city": "", "state": "CA", "zip": "", "country": "United States", "approved": true }, "abstract": "X-ray crystallography is a powerful tool for determining the atomic positions of proteins, used by researchers at synchrotrons and X-ray free electron lasers. Typically, the crystal is exposed to X-rays, which diffract and are collected on a detector to create diffraction patterns. These patterns are processed by software designed to seek out weak signal on the images and create datasets from which the protein structure can be solved. The DIALS diffraction data processing package is a mature product produced in collaboration between LBNL and Diamond Light Source (UK) that has primarily been supported in the US by research funding. DIALS is used at a number of synchrotrons world-wide for regular processing of user datasets and has been used at X- ray free electron lasers for fast processing of large datasets collected at hundreds to thousands of images per second. The program allows fast feedback of data quality when incorporated into automated processing that allows users to quickly make decisions about beamline operation and experimental direction. This has allowed researchers to produce high-impact structures in general biological fields, including human diseases such as COVID-19 and malaria, and energy research such as photosynthesis. This proposal would create a US R24 National Resource for the DIALS diffraction data processing package. The Resource would move DIALS funding in the US from primarily R01 research funding to a combination of separate research funding and operational funding from this proposal. The operational funding would be to support codebase optimization, maintenance, and refactoring, a build-and-release schedule, and new robust and adaptable user interfaces. Further, it would provide user outreach and training, both for general users, and through on-site training for beamline scientists to help with software integration into existing pipelines. The end result will be a well-maintained and documented software package used at synchrotrons and XFELs for routine data analysis without user intervention, and robust support for difficult cases.", "keywords": [], "approved": true } }, { "type": "Grant", "id": "15319", "attributes": { "award_id": "1R44CA295355-01", "title": "PyroTIMER Technology: Enabling T-Cell Persistence in Immunosuppressive Tumor Microenvironments", "funder": { "id": 4, "ror": "https://ror.org/01cwqze88", "name": "National Institutes of Health", "approved": true }, "funder_divisions": [ "National Cancer Institute (NCI)" ], "program_reference_codes": [], "program_officials": [ { "id": 31912, "first_name": "SWAMY KRISHNA", "last_name": "Tripurani", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "start_date": "2024-09-23", "end_date": "2026-08-31", "award_amount": 748337, "principal_investigator": { "id": 31913, "first_name": "ARCHIS", "last_name": "BAGATI", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] }, "other_investigators": [], "awardee_organization": { "id": 2532, "ror": "", "name": "PYROJAS INC", "address": "", "city": "", "state": "NY", "zip": "", "country": "United States", "approved": true }, "abstract": "The challenge of effectively treating cancer is further complicated by the limitations of current CAR-T cell therapies, especially when confronted with the immunosuppressive tumor microenvironment (TIME). Central to this issue is the transforming growth factor-beta (TGF-β), which induces T cell exhaustion and curtails their antitumor potency. Current methodologies to inhibit the TGF-β pathway have yielded suboptimal results due to transient effects. This project introduces PyroTIMER CAR-T cells, an innovative approach that promises durable inhibition of all TGF-β isoforms within the TIME. This robust strategy not only targets TGF-β with unprecedented potency but also incorporates multiple technical advancements, enhancing T cell cytotoxicity and leveraging patient-derived xenograft (PDX) models for a more accurate representation of the tumor milieu. The overarching research plan is to thoroughly assess PyroTIMER CAR-T cells in both immunocompetent syngeneic models and PDX models. Employing multi-parametric flow cytometry, we aim to delve into the immune dynamics within tumors, elucidating how PyroTIMER CAR-T cells interact with and potentially remodel the TIME. Our objectives are four-fold: 1. Deciphering the influence of TGF-β on PyroTIMER CAR-T cells. 2. Profiling cytokine production to gauge risks, particularly concerning cytokine release syndrome (CRS). 3. Investigating potential exhaustion scenarios in PyroTIMER CAR-T cells. 4. In-depth in vivo evaluations of the safety and efficacy of PyroTIMER CAR-T cells. Our long-term trajectory is underpinned by a commitment to patient safety and therapeutic efficacy. By forging collaborations with pharmaceutical entities, refining manufacturing strategies for scalability, and seeking FDA endorsement, we aspire to position PyroTIMER CAR-T cells at the forefront of personalized cancer therapies. This initiative represents a harmonious blend of advanced scientific inquiry, patient well-being, and strategic commercial planning. Through this endeavor, we aim to redefine CAR-T cell therapy, presenting a novel, potent, and safer treatment paradigm for cancer patients.", "keywords": [], "approved": true } }, { "type": "Grant", "id": "15314", "attributes": { "award_id": "1R41AT012854-01", "title": "A scalable intervention for stress management practices", "funder": { "id": 4, "ror": "https://ror.org/01cwqze88", "name": "National Institutes of Health", "approved": true }, "funder_divisions": [ "National Center for Complementary and Integrative Health (NCCIH)" ], "program_reference_codes": [], "program_officials": [ { "id": 31902, "first_name": "Emrin U", "last_name": "Horgusluoglu", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "start_date": "2024-09-17", "end_date": "2025-08-31", "award_amount": 294312, "principal_investigator": { "id": 31903, "first_name": "Milton", "last_name": "Aguirre", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] }, "other_investigators": [], "awardee_organization": { "id": 2531, "ror": "", "name": "LIVOTION LLC", "address": "", "city": "", "state": "MA", "zip": "", "country": "United States", "approved": true }, "abstract": "Roughly 60% of college students meet the criteria for at least one mental health disorder, with anxiety and depression being the most common diagnoses. The number of students seeking help for mental health issues increased by almost 40% at campus counseling centers between 2009 and 2015 and has continued to rise since the onset of the COVID-19 pandemic, yet the demand has not been proportionately matched with increased funding to support mental health provision on college campuses. Thus, college students require a different approach to managing the stress that exacerbates their mental health symptoms. Technology-based breathing interventions for stress management, which have been shown to prevent and remediate stress, are growing in popularity with the rise of commercially available mobile apps and bio-feedback technologies that do not require the help of a professional. However, while such mHealth interventions are now widely available, they often fail because they do not lend themselves to use in real-world settings. Most technology-based interventions require the use of mobile phones ─ a disruptive and often unwelcome behavior in most educational settings. Existing biofeedback devices (e.g., chest straps, clip-ons, inhalers) are similarly contextually inappropriate, making use obvious, distracting, and potentially stigmatizing. To overcome these barriers, the PI developed the AIRpen, a simple, affordable, multi-functional stress management device that is designed to fit into the fabric of users’ lives to potentially optimize the delivery, practice, and fidelity of diaphragmatic breathing (DB) interventions in real\u0002world settings. With anecdotal and empirical evidence supporting the device as feasible and acceptable in real\u0002world academic settings (Purdue IRB-2022-423), this Phase I STTR project proposes the following aims: Aim 1. Develop and refine the AIRpen intervention to enable the use of the device without oversight by a professional. Aim 2: Develop Smart AIRpen prototypes, which are equipped with sensors to measure user adherence in future real-world effectiveness studies. Aim 3: Establish the usability and acceptability of the AIRpen intervention with a sample of 60 college students (30 in each device group) in a laboratory setting and gather preliminary feedback on subject-reported stress using physiological and subjective surveys as a secondary outcome. Aim 4: Establish the feasibility of a future real-world research study that will evaluate the usability and acceptability of the AIRpen intervention when used during an exam period with a sample of 30 college students. Secondary outcome data utilizing subject-reported stress measures will also be collected. Results will support future larger-scale effectiveness trials and inform future protocol designs for scaling cost-effective and time-efficient treatments that broadly support the development of coping skills for stress management.", "keywords": [], "approved": true } }, { "type": "Grant", "id": "15312", "attributes": { "award_id": "1R35GM152454-01", "title": "Endothelial mechanisms of multiorgan dysfunction", "funder": { "id": 4, "ror": "https://ror.org/01cwqze88", "name": "National Institutes of Health", "approved": true }, "funder_divisions": [ "National Institute of General Medical Sciences (NIGMS)" ], "program_reference_codes": [], "program_officials": [ { "id": 22508, "first_name": "CHIEN-CHUNG", "last_name": "Chao", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "start_date": "2024-09-15", "end_date": "2029-08-31", "award_amount": 409583, "principal_investigator": { "id": 31899, "first_name": "Alejandro Pablo", "last_name": "Adam", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] }, "other_investigators": [], "awardee_organization": { "id": 2530, "ror": "", "name": "ALBANY MEDICAL COLLEGE", "address": "", "city": "", "state": "NY", "zip": "", "country": "United States", "approved": true }, "abstract": "Three different fates await the millions of critically ill patients admitted to intensive care units every year. Close to 30% will recover without obvious sequelae, 15% succumb to the acute illness, and the remainder 55% will develop various degrees of long-term impairments in cognitive, immune, cardiovascular, or renal functions, leading to increased overall mortality. These sequelae are diagnosed under the umbrella term post-intensive care syndrome (PICS). We lack the knowledge to improve acute survival, and to predict and treat PICS. Largely, therapies for septic shock and other critially ill patients are limited to infectious source control and hemodynamic support. Severe systemic inflammatory reactions, including sepsis, often lead to shock, organ failure and death, in part through an acute release of cytokines that promote vascular dysfunction. The current body of work, including our own research, strongly argues for a critical role for the endothelium in determining the outcomes of critical illness through expression of multiple proteins to promote disseminated intravascular coagulopathy, leukostasis and edema. However, simply blocking cytokine activity does not improve survival, in large part due to the immunosuppresive actions of these treatments. It is imperative to rethink the problem. We posit that a better understanding of the endothelial mechanisms downstream of cytokine signaling will lead to improved therapies to prevent organ damage and mortality without interfering with the required pathogen clearance. Little is known about the endothelial signaling pathways regulating the transcriptional profile in failing organs. This proposal is designed to take full advantage of the innovative tools and knowledge we developed during the last several years to ask fundamental mechanistic questions on the role of endothelial signaling and transcriptional responses during severe inflammation. Sourcing of human primary endothelial cells in-house allows us to perform mechanistic studies in a cost-effective manner, a panel of endothelial-specific transgenic mice enables us to study key regulators of transcription in the context of multiorgan dysfunction, and clinical collaborators provide us with unique human specimens to ensure the translatability of our research. Our prior findings of a critical role for the IL6-STAT3-SOCS3 signaling axis in the endothelium provides a strong scientific basis for the proposed working model, and our new unpublished bioinformatics analysis of endothelial translatome of failing organs suggest several novel IL6 effectors of endotheliopathy, providing initial targets for further research. We aim at determining which changes dictate the severity of acute shock (and thus short-term survival), and which lead to long-term consequences well beyond the resolution of the initial shock. Key questions driving our research are: 1) What are the effectors downstream of a cytokine storm that we can target to limit organ dysfunction without limiting the immune response? 2) What are the main drivers of long-term consequences and chronic inflammation after shock recovery? 3) How can we take advantage of the complexity of the endothelial response to tailor it towards a pro-immune response while limiting the collateral damage? The outcome of our efforts in answering these critical questions is the discovery of key determinants of organ failure. The knowledge gained may lead to innovative non-immunosuppressive therapeutic strategies to limit organ dysfunction.", "keywords": [], "approved": true } }, { "type": "Grant", "id": "15303", "attributes": { "award_id": "1R01AI179898-01A1", "title": "Characterization and optimization of single dose, thermostable and durable vaccine platform towards increased clinical acceptance", "funder": { "id": 4, "ror": "https://ror.org/01cwqze88", "name": "National Institutes of Health", "approved": true }, "funder_divisions": [ "National Institute of Allergy and Infectious Diseases (NIAID)" ], "program_reference_codes": [], "program_officials": [ { "id": 6908, "first_name": "JENNIFER L.", "last_name": "Gordon", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "start_date": "2024-08-23", "end_date": "2029-06-30", "award_amount": 604137, "principal_investigator": { "id": 31894, "first_name": "Nerea", "last_name": "Zabaleta", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] }, "other_investigators": [], "awardee_organization": { "id": 2529, "ror": "", "name": "SCHEPENS EYE RESEARCH INSTITUTE", "address": "", "city": "", "state": "MA", "zip": "", "country": "United States", "approved": true }, "abstract": "SUMMARY/ABSTRACT Broadening the spectrum of vaccine platforms that confer protective, durable and broad immunogenicity is important for pandemic preparedness. Here, we aim to create essential preclinical data to characterize a novel genetic vaccine platform called PARVAX to increase its clinical acceptance. Our previous studies show that a single dose of PARVAX candidates for COVID-19 elicits sustained humoral immunity, near-sterilizing upper and lower airway protection from a SARS-CoV-2 challenge, and potent and durable cellular responses. These qualities combined with established commercial and low-cost manufacturing processes, make this platform imminently feasible, scalable and affordable for vaccine applications. In this proposal, we will investigate the mechanism behind the potency and durability of PARVAX, which we hypothesize is correlated with antigen expression kinetics (Aim 1). We also use rational engineering approaches to enhance the potency of the PARVAX platform, which will enhance safety and applicability for other pathogens (Aim 2). Finally, we propose to generate proof of the potency of PARVAX as a vaccine platform beyond COVID-19 by exploring the serum and mucosal immunity and protection from influenza viruses in two preclinical models of influenza infection (Aim 3). The proposed work is highly relevant for pandemic preparedness, since it will enable the rapid design of new and preclinically derisked PARVAX candidates for existing and future pathogens, and has the potential to provide clarity on the means to improve the durability, breadth and mucosal immunity of other platforms.", "keywords": [], "approved": true } }, { "type": "Grant", "id": "15299", "attributes": { "award_id": "1R44CA291521-01", "title": "A Phase 1 Study of Patient-Derived Multi-Tumor-Associated Antigen Specific T Cells (MT-601) Administered to Patients with Relapsed Non-Hodgkin Lymphoma", "funder": { "id": 4, "ror": "https://ror.org/01cwqze88", "name": "National Institutes of Health", "approved": true }, "funder_divisions": [ "National Cancer Institute (NCI)" ], "program_reference_codes": [], "program_officials": [ { "id": 22312, "first_name": "Patricia A", "last_name": "Weber", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "start_date": "2024-08-01", "end_date": "2027-07-31", "award_amount": 665000, "principal_investigator": { "id": 31891, "first_name": "Juan fernando", "last_name": "Vera", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] }, "other_investigators": [], "awardee_organization": { "id": 2528, "ror": "", "name": "MARKER THERAPEUTICS, INC.", "address": "", "city": "", "state": "TX", "zip": "", "country": "United States", "approved": true }, "abstract": "This application presents MT-601, a novel multi-tumor associated antigen (mTAA)-specific T cell product for the treatment of Non-Hodgkin’s Lymphoma (NHL). NHL is the most common hematologic malignancy with ~80,550 new cases and >20,000 deaths in the US expected in 2023. Adoptive T cell transfer, e.g., CAR T cells, have impressive potency in NHL yet are also associated with cytokine release syndrome (CRS) and neurotoxicity. Additionally, relapse rates are up to 60% post-CAR T therapy due to low antigen levels or loss of CD19 expression. To date there are no approved therapies for NHL patients who relapsed after CAR T cell therapy, resulting in a huge unmet medical need for alternate treatment options for NHL. MT-601 represents a novel T cell-based immunotherapy that simultaneously targets 6 tumor-associated antigens (TAA) (PRAME, NY-ESO1, survivin, MAGE-A4, SSX2, WT1) that are overexpressed in NHL but absent or with limited expression in healthy tissue, thereby minimizing tumor escape and enhancing anti-tumor response. Manufactured from autologous apheresis material, MT-601 recognizes target cells via native T cell receptors by interacting with tumor antigen-expressing target cells presenting antigen in the context of both class I and II HLA, leading to killing of tumor cells expressing any of these antigens and recruiting the patient’s immune system in the anti-tumor response. Although other cellular immunotherapies attempt to address CD19 CAR T cell failures by targeting 2-3 antigens, they are limited by 1) narrow epitope recognition, and 2) leaving the tumor susceptible to relapse. In addition to broad-spectrum antigen targeting, MT-601 is the only cellular therapy being explored in NHL patients who relapsed following CAR T therapy. Additional advantages of MT-601 include out-patient administration and no genetic engineering. Furthermore, Marker’s multiTAA-specific technology was proven clinically safe in >180 patients with various kinds of cancer. In a phase 1 trial of lymphoma patients using multiTAA-specific T cells targeting 5 TAAs, patients had durable responses for much longer than those typically associated with CAR T cells (6 years versus 28 months). Notably, Marker recently treated our first CAR T cell relapsed NHL patient, who shows a complete response at 12 weeks post-infusion. Based on this promising clinical data, Marker proposes a single-arm Phase 1 clinical study to advance MT-601 for patients with NHL that relapsed after third line CAR T treatment and do not have other approved therapy options. The objective of Specific Aim 1 is to manufacture MT-601 and execute the clinical protocol by treating NHL patients who have relapsed after CD19 CAR T cell therapy with MT-601. Specific Aim 2 will correlate biological characteristics in the product profile with clinical safety and efficacy outcomes. Successful completion of this grant will provide clinical proof of concept for MT-601 as a treatment for CAR relapsed NHL patients, and support future clinical trials leading to future BLA filing and commercial approval of MT-601.", "keywords": [], "approved": true } }, { "type": "Grant", "id": "15297", "attributes": { "award_id": "1R01HL168579-01A1", "title": "Analysis of immunologic mechanisms in patients with chronic lung disease after acute COVID infection", "funder": { "id": 4, "ror": "https://ror.org/01cwqze88", "name": "National Institutes of Health", "approved": true }, "funder_divisions": [ "National Heart Lung and Blood Institute (NHLBI)" ], "program_reference_codes": [], "program_officials": [ { "id": 22653, "first_name": "EMMANUEL FRANCK", "last_name": "Mongodin", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "start_date": "2024-08-15", "end_date": "2028-05-31", "award_amount": 752410, "principal_investigator": { "id": 31888, "first_name": "Homer L", "last_name": "Twigg", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] }, "other_investigators": [], "awardee_organization": { "id": 2527, "ror": "https://ror.org/03eftgw80", "name": "Indiana University Indianapolis", "address": "", "city": "", "state": "IN", "zip": "", "country": "United States", "approved": true }, "abstract": "As of February 8, 2023 more than 102.7 million cases of SARS-CoV-2 infection leading to COVID-19 disease have occurred in the United States. Besides the acute morbidity and mortality associated with hospitalization, many patients with COVID-19 develop prolonged complications in the lung characterized by long term respiratory symptoms and radiographic changes due to pulmonary fibrotic and inflammatory processes. Some reports suggest 60-70% of patients who had severe COVID-19 infection will have residual pulmonary disease with fibrosis and/or ground glass opacities on chest imaging consistent with persistent lung inflammation. What drives the chronic immune and inflammatory response is unclear, but persistent viral antigen stimulation well after acute infection has resolved has been described in many viral infections. Persistent immune stimulation can lead to chronic inflammation through multiple mechanisms, including induction of innate immunity, chronic B and T cell responses, and immunosenescence, a highly pro-inflammatory process due to repeated T cell stimulation. In preliminary data we have extensively characterized the alveolar milieu in patients presenting with post COVID- lung disease up to 2 years after being diagnosed with acute infection. We have identified three patterns based on bronchoalveolar lavage (BAL) characteristics: a benign BAL pattern associated with stable lung scaring, a neutrophilic BAL pattern associated with increased cytokine concentrations and pulmonary fibrotic changes, and a lymphocytic pattern associated with increased chemokine concentrations and ground glass opacities on chest imaging. Importantly, we describe persistence in BAL of SARS-CoV-2 RNA in 85% of subjects and spike protein in half the subjects we have studies do far. In this project we hypothesize that chronic lung disease after COVID-19 infection is due to persistent viral proteins in the lung and a poor pulmonary immune response to SARS-COV-2. To address this hypothesis we propose the following specific aims. (1) To obtain bronchoalveolar lavage and peripheral blood for mechanistic studies on a cohort of patients who have persistent lung disease after acute COVID infection, including repeat follow up bronchoscopies on a subset of patients. (2) To further characterize BAL cellular and inflammatory patterns in patients with post COVID lung disease and link them with clinical diagnoses. (3) To assess COVID specific pulmonary humoral and cellular immune responses in patients with post COVID lung disease to determine linkages between COVID specific immunity, failure to clear viral RNA and proteins, and subsequent pulmonary disease. We have the capacity to recruit patients with post COVID lung disease who have BAL available for study and perform detailed cellular, inflammatory mediator, and SARS-CoV-2 specific immune analysis to explore potential mechanisms for the different pulmonary phenotypes seen. We feel the approaches utilized in this study will provide valuable information on post COVID lung disease, suggest approaches to management and treatment, and may be even be applicable to future studies on lung diseases after other viral infections.", "keywords": [], "approved": true } }, { "type": "Grant", "id": "15420", "attributes": { "award_id": "3U01AA026817-05S1", "title": "S-adenosylmethionine treatment in alcoholic cirrhosis", "funder": { "id": 4, "ror": "https://ror.org/01cwqze88", "name": "National Institutes of Health", "approved": true }, "funder_divisions": [ "National Institute on Alcohol Abuse and Alcoholism (NIAAA)" ], "program_reference_codes": [], "program_officials": [ { "id": 10229, "first_name": "Gary", "last_name": "Murray", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "start_date": "2024-06-01", "end_date": "2025-08-31", "award_amount": 273786, "principal_investigator": { "id": 32028, "first_name": "Bin", "last_name": "Gao", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] }, "other_investigators": [ { "id": 32029, "first_name": "Suthat", "last_name": "Liangpunsakul", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] }, { "id": 32030, "first_name": "Shelly Chi-Loo", "last_name": "Lu", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "awardee_organization": { "id": 2527, "ror": "https://ror.org/03eftgw80", "name": "Indiana University Indianapolis", "address": "", "city": "", "state": "IN", "zip": "", "country": "United States", "approved": true }, "abstract": "Alcoholic cirrhosis is a leading cause of morbidity and mortality in the US. One of the key drivers in its pathogenesis is the reduction in hepatic methionine adenosyltransferase 1A (MAT1A) expression resulting in the reduction in hepatic S-adenosylmethionine (SAMe) levels. The reduction in SAMe level leads to several adverse intracellular consequences, which include promoting the inflammatory cascades in immune cells such as macrophages by lipopolysaccharides (LPS), oxidative stress and endoplasmic reticulum (ER) stress. This project involves two academic centers in the United States (Cedars-Sinai Medical Center in Los Angeles and Indiana University Hospital), a research institute in Spain (CIC bioGUNE), and NIAAA intramural liver research scientist (Dr. Bin Gao) to examine SAMe in humans with alcoholic cirrhosis. We proposed a randomized double-blind placebo controlled trial to determine the efficacy of SAMe (1,200 mg/day given in two divided dose) and its mechanistic effects in patients with alcoholic cirrhosis (Child class A and B) in the real world setting. The primary endpoint will be the mortality of any causes between groups. The target enrollment of our clinical trial is 196 participants (176 patients with alcohol-associated cirrhosis and 20 controls). The approval for funding of our study started on September 20, 2019. However, our study was significantly impacted by the COVID-19 pandemic in 2020 and 2021. The administrative hold on research activities due to the pandemic prohibited us to enroll patients as we anticipated. To date, 112 participants (~57%) were enrolled. Our enrollment continues to improve and meet the monthly target enrollment starting around the beginning of Yr 3 of the project (~September 2021, the time when the overall COVID-19 pandemic was improving). Given the trajectory of the enrollment, we anticipated that we should be able to complete our enrollment around August 2026. Our current funding ends on 8/31/24. This supplemental application is to allow us to complete the clinical trial, currently being funded by 1U01AA02681.", "keywords": [], "approved": true } }, { "type": "Grant", "id": "15292", "attributes": { "award_id": "1F31HD115324-01", "title": "Associations among maternal stress, infant epigenetics, and behavioral and cognitive development across the first few years of life", "funder": { "id": 4, "ror": "https://ror.org/01cwqze88", "name": "National Institutes of Health", "approved": true }, "funder_divisions": [ "Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)" ], "program_reference_codes": [], "program_officials": [ { "id": 8605, "first_name": "JAMES", "last_name": "GRIFFIN", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "start_date": "2024-08-01", "end_date": "2026-07-31", "award_amount": 42574, "principal_investigator": { "id": 31883, "first_name": "Jessica", "last_name": "Sperber", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] }, "other_investigators": [], "awardee_organization": { "id": 2526, "ror": "", "name": "COLUMBIA UNIVERSITY TEACHERS COLLEGE", "address": "", "city": "", "state": "NY", "zip": "", "country": "United States", "approved": true }, "abstract": "This F31 NRSA application will provide the applicant with the training necessary to achieve their goal of becoming an independently-funded researcher integrating perspectives from developmental psychology, neuroscience, and prevention science. This dissertation project seeks to incorporate epigenetic aging as a biomarker and potential mechanism to explain the association between maternal stress and behavioral and cognitive development over the first few years of life. The application proposes training in: 1) the integration of epigenetic aging into the larger study of maternal stress and child development; 2) the methodology for DNA methylation extraction and analysis; and 3) advanced longitudinal models. The sponsorship team consists of experts in the fields of Psychology, Neuroscience, and Education from both Teachers College, Columbia University and University of Texas-Austin. The resources afforded by these sponsors and institutions will facilitate the applicant’s goal of integrating multimodal and interdisciplinary methods to improve the trajectories of children experiencing early life stress. RESEARCH PROJECT: Maternal stress during pregnancy and early childhood is a robust predictor of deleterious outcomes for children’s cognitive and behavioral development. Epigenetic processes are a powerful mechanism to explain how adverse experiences biologically embed to predict later functioning. Accelerated aging reflects a biological age that exceeds one’s chronological age, and is tightly linked with both early life stress and negative physical and mental health outcomes in adults. However, little is understood about these associations during early childhood. The reported spike in maternal stress since the onset of the COVID- 19 pandemic highlights the urgency with which researchers must examine how stress biologically embeds to predict later functioning. The present study will leverage an existing birth cohort of socioeconomically diverse families from New York City to examine the longitudinal associations among maternal stress, accelerated aging, and cognition and behavioral regulation in early childhood, with the following Aims: 1) Examine the longitudinal, stress-related alterations in epigenetic age across early childhood; 2) Examine biomarkers and cognitive effects of the COVID-19 pandemic in mothers and children; and 3) Examine whether accelerated aging predicts cognition and behavioral regulation in childhood. Maternal stress will be assessed both prenatally and at various points throughout the first three of years of the child’s life. Both perceived and physiological measures of stress will be examined in these associations. Children will provide saliva samples at 1-month and 30-months of age to examine epigenetic age and complete well-validated assessments of cognition and behavioral regulation at 30- months. Findings will elucidate the relationships between maternal stress and accelerated aging during childhood and the functional relevance of accelerated aging to children’s behavior and cognition.", "keywords": [], "approved": true } }, { "type": "Grant", "id": "15287", "attributes": { "award_id": "1R43DA060696-01", "title": "Software as a Medical Device for detecting opioid use through voice.", "funder": { "id": 4, "ror": "https://ror.org/01cwqze88", "name": "National Institutes of Health", "approved": true }, "funder_divisions": [ "National Institute on Drug Abuse (NIDA)" ], "program_reference_codes": [], "program_officials": [ { "id": 12311, "first_name": "LEONARDO MARIA", "last_name": "Angelone", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "start_date": "2024-08-01", "end_date": "2025-07-31", "award_amount": 400000, "principal_investigator": { "id": 31875, "first_name": "Rima", "last_name": "Seiilova-Olson", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] }, "other_investigators": [], "awardee_organization": { "id": 2525, "ror": "", "name": "TENVOS INC.", "address": "", "city": "", "state": "CA", "zip": "", "country": "United States", "approved": true }, "abstract": "Patients affected by opioid use disorder (OUD) face numerous challenges, ranging from stigma to policy barriers that impede their access to care. Even after engaging OUD patients in treatment, retention rates are disappointingly low due to a multitude of factors. Despite the widespread adoption of virtual counseling and treatment solutions, such as telemedicine programs using medications for opioid use disorder (MOUD), during the COVID-19 pandemic, addiction treatment still requires in-person visits for regular drug testing. However, this requirement can lead to non-compliance and being dropped from what is often their only therapeutic option available. Innovative and FDA-cleared opioid use testing methods that can be performed outside of laboratory environments address these issues and hold the promise of increasing retention rates and improving clinical outcomes. Tenvos’ product will be integrated into a smartphone app, enabling patients to test for opioid use from the comfort of their home and send instant results to the clinician without the need for an in-person visit. The proposed solution will not only improve clinical outcomes in the outpatient OUD treatment setting but can be adopted in many other settings due to its convenience and can, potentially, unlock new workflows that were not feasible before. The FDA-regulated SaMD itself, which is a ML-based solution, will be exposed through an API enabling its integration into a large number of systems and applications. The API can be integrated into virtual health solutions and provide opioid use assessment real-time during an appointment. It can be integrated into a wearable device and serve as a remote patient monitoring device that notifies the treating physician in case of a relapse. It can also be used for population health and risk stratification by integrating into case management calls at managed care organizations to identify individuals who may benefit from OUD treatment. The specific aims for the Phase I set of activities include: Aim 1: Collecting clinical data with gold standard test results and patient voice samples to study the correlation between them. Aim 2: Validating and fine-tuning the machine learning models with the collected clinical data. Aim 3: Engaging with the FDA Center of Devices and Radiological Health (CDRH) through a pre-submission process to obtain feedback on the most appropriate pathway, such as PMA, De Novo, or 510(k).", "keywords": [], "approved": true } } ], "meta": { "pagination": { "page": 3, "pages": 1392, "count": 13920 } } }