2014-10-14T09:14:00-07:00
Resource:ONE Study
ONE Study
University Hospital Regensburg
Department of Surgery
Franz-Josef-Strauss-Allee 11
93053 Regensburg
Germany
Type: Academia <br />
Participant countries: International <br />
Country started: E.U. <br />
Number of partners: 13 <br />
Start date: 2011
curated
http://www.onestudy.org/
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.
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Resource:ONE Study
2014-10-13T00:00:00
Resource
The ONE Study
The ONE Study - A Unified Approach to Evaluating Cellular Immunotherapy in Solid Organ Transplantation
A Unified Approach to Evaluating Cellular Immunotherapy in Solid Organ Transplantation
Resource
Synonym
FP7
European Union
Supporting Agency
SuperCategory
Human
Species
Kidney transplant
Related disease
Resource:ALTA
Resource:Pharmatching
Resource:KOEHLER eClinical
Resource:Beckman Coulter
Resource:Electro Scientific Industries
Resource:Miltenyi Biotec
Massachusetts General Hospital; Massachusetts; USA
University of California at San Francisco; California; USA
University of Wisconsin-Madison; Wisconsin; USA
Loughborough University; England; United Kingdom
Nantes University Hospital; Nantes; France
Resource:Fondazione Centro San Raffaele; Milan; Italy
Charite - Universitatsmedizin Berlin; Berlin; Germany
University of Oxford; Oxford; United Kingdom
King's College London; London; United Kingdom
University of Regensburg; Bavaria; Germany
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Resource:Consortia-pedia
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Label
Hematopoietic immunoregulatory cell
Immunosuppression
Transplant surgery
Drug development
Healthcare
Basic research
Tool development
Immune system
Clinical
Cell therapy
Clinical trial
Kidney
Organ transplant
Immune response
Keywords
University Hospital Regensburg; Bavaria; Germany
Is part of
Id
Consortium
Has role
File:ONE Study.PNG
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