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URL: http://www.onestudy.org/

Proper Citation: ONE Study (RRID:SCR_003886)

Description: Consortium aiming to produce regulatory T cells that are compatible with a kidney transplant patient''''s immune system, as a measure to suppress the body''''s natural immune response against a transplanted organ. If successful, this approach will reduce a transplantation patient''''s life-long dependency on immune suppressing drugs, many of which are often associated with undesirable side effects and can limit the patient''''s daily routine. The consortium goals are to develop and conduct clinical trials of various immunoregulatory T-cell-based products in organ transplantation recipients, allowing a direct comparison of the safety, clinical practicality and therapeutic efficacy of each cell type. The central focus of the project is to: # Production and manufacture of distinct populations of hematopoietic immunoregulatory T cells # Comparatively study the tolerogenic characteristics of these regulatory cell types # Test these cell therapy products side by side in a clinical trial living donor renal transplant recipients The first workstream will work with different T regulatory cell, tolerogenic DC and suppressive macrophage cell products that are currently in development. In addition to these therapeutics, another goal of this workstream is to develop a cell tracking technology that assesses pharmacodynamics and pharmacokinetics of these cell-based therapies. The second workstream is focused on designing and conducting a cell therapy based clinical trial in renal transplantation, taking into consideration ethics, concurrent immunosuppressive drug use, state-of-the-art immune monitoring, innovative all-in-one data capturing systems, and pharmacovigilance. The goal is to have a comparative evaluation of hematopoietic cell therapy safety in renal transplantation. The third workstream aims to learn more about the specific comparative characteristics of suppressive cell types and to use this knowledge to improve later trial designs and foster novel ideas for new or improved suppressive / tolerogenic cell population.

Abbreviations: ONE Study

Synonyms: A Unified Approach to Evaluating Cellular Immunotherapy in Solid Organ Transplantation, The ONE Study - A Unified Approach to Evaluating Cellular Immunotherapy in Solid Organ Transplantation, The ONE Study

Resource Type: consortium, data or information resource, portal, organization portal

Keywords: immune response, organ transplant, kidney, clinical trial, cell therapy, clinical, immune system, tool development, basic research, healthcare, drug development, transplant surgery, immunosuppression, hematopoietic immunoregulatory cell