THE ONE STUDY
A Unified Approach to Evaluating Cellular Immunotherapy in Solid Organ Transplantation
| Coordinatore | KLINIKUM DER UNIVERSITAET REGENSBURG
Organization address
address: FRANZ JOSEF STRAUSS ALLEE 11 contact info |
| Nazionalità Coordinatore | Germany [DE] |
| Totale costo | 14˙696˙602 € |
| EC contributo | 10˙836˙201 € |
| Programma | FP7-HEALTH
Specific Programme "Cooperation": Health |
| Code Call | FP7-HEALTH-2010-single-stage |
| Funding Scheme | CP-IP |
| Anno di inizio | 2010 |
| Periodo (anno-mese-giorno) | 2010-11-01 - 2016-10-31 |
Partecipanti
| # | ||||
|---|---|---|---|---|
| 1 |
KLINIKUM DER UNIVERSITAET REGENSBURG
Organization address
address: FRANZ JOSEF STRAUSS ALLEE 11 contact info |
DE (REGENSBURG) | coordinator | 3˙620˙543.00 |
| 2 |
CHARITE - UNIVERSITAETSMEDIZIN BERLIN
Organization address
address: Chariteplatz 1 contact info |
DE (BERLIN) | participant | 1˙800˙200.00 |
| 3 |
THE CHANCELLOR, MASTERS AND SCHOLARS OF THE UNIVERSITY OF OXFORD
Organization address
address: University Offices, Wellington Square contact info |
UK (OXFORD) | participant | 1˙003˙922.00 |
| 4 |
KING'S COLLEGE LONDON
Organization address
address: Strand contact info |
UK (LONDON) | participant | 960˙001.00 |
| 5 |
CENTRE HOSPITALIER UNIVERSITAIRE DE NANTES
Organization address
address: Allee de l'Ile Gloriette 5 contact info |
FR (NANTES) | participant | 678˙000.00 |
| 6 |
MILTENYI BIOTEC GMBH
Organization address
address: FRIEDRICH EBERT STRASSE 68 contact info |
DE (BERGISCH GLADBACH) | participant | 460˙000.00 |
| 7 |
THE REGENTS OF THE UNIVERSITY OF CALIFORNIA
Organization address
address: "FRANKLIN STREET 1111, 12 FLOOR" contact info |
US (OAKLAND CA) | participant | 442˙387.60 |
| 8 |
Fondazione Centro San Raffaele
Organization address
address: Via Olgettina 60 contact info |
IT (Milano) | participant | 387˙000.00 |
| 9 |
ALTA RICERCA E SVILUPPO IN BIOTECNOLOGIE SRLU
Organization address
address: VIA FIORENTINA 151 contact info |
IT (SIENA) | participant | 350˙000.00 |
| 10 |
CLINIT AG
Organization address
address: HORNUSSTRASSE 16 contact info |
DE (FREIBURG) | participant | 314˙000.00 |
| 11 |
Electro Scientific Industries Europe Ltd.
Organization address
address: "Avro Court, Ermine Business Park 8" contact info |
UK (Huntingdon) | participant | 293˙760.00 |
| 12 |
UNIVERSITY OF WISCONSIN-MADISON
Organization address
address: 161 BASCAM HALL 500 LINCOLN DR. contact info |
US (WISCONSIN) | participant | 200˙000.00 |
| 13 |
LOUGHBOROUGH UNIVERSITY
Organization address
address: Ashby Road contact info |
UK (LOUGHBOROUGH) | participant | 154˙318.00 |
| 14 |
The General Hospital Corporation
Organization address
address: Fruit Street 55 contact info |
US ("Boston, Massachusetts") | participant | 140˙020.00 |
| 15 |
PHARMATCHING GMBH
Organization address
address: WIPPERTSTRASSE 2 contact info |
DE (FREIBURG IM BREISGAU) | participant | 32˙049.28 |
| 16 |
FONDAZIONE CENTRO SAN RAFFAELE DEL MONTE TABOR
Organization address
address: Via Olgettina 60 contact info |
IT (MILANO) | participant | 0.00 |
Mappa
Word cloud
Esplora la "nuvola delle parole (Word Cloud) per avere un'idea di massima del progetto.
Obiettivo del progetto (Objective)
'Preventing immunological rejection of transplanted organs without the need for long-term use of pharmacological immunosuppression is a primary objective in transplantation medicine. Reducing the need for immunosuppression would dramatically improve the outcome for transplant recipients and reduce health costs for society. The means to achieve this goal has not been realised with pharmacological or biological agents yet. Conditioning the immune response of solid organ transplant recipients towards allograft acceptance using cell-based therapies is now becoming technically feasible and clinically promising. The central focus of our proposed cooperative work programme is to produce distinct populations of haematopoietic regulatory cells and comparatively test their safety and efficacy in minimising pharmacological immunosuppression in solid organ transplantation. Preparations of regulatory T cells, macrophages and dendritic cells will be licensed for clinical manufacture in outstanding research facilities across Europe, and subsequently, these different tolerance-promoting cell types will be assessed in a single Phase I/II clinical study for safety, clinical practicality and efficacy. The therapeutic potential of these cells will be directly compared using one, single clinical protocol. In addition, we will study the tolerogenic characteristics of these regulatory cell types at in-depth molecular and functional levels. These integrative, but very focused, research plans are expected to result in the identification of the most promising regulatory cell products for further testing, and commercial exploitation: the final outcome is to identify a cell product which has genuine potential to induce operational tolerance if correctly applied in a Phase IIb clinical trial. This objective can only be accomplished by the cooperation of the most experienced researchers in this field across Europe, in alliance with SMEs devoted to cell therapy.'
Introduzione (Teaser)
A group of new clinical trials is investigating whether delivery of different immune cells can reduce the need for immunosuppressive drugs in organ transplantion. Positive results will improve the outcome for transplant recipients and reduce health costs for society.
Descrizione progetto (Article)
Rejection of implanted organs remains a major problem despite recent advances in immunosuppression. The pharmacological treatment of patients after transplantation causes severe side-effects that can include susceptibility to opportunistic infections and even increased cancer occurrence.
The EU-funded project 'A unified approach to evaluating cellular immunotherapy in solid organ transplantation' (http://www.onestudy.org (THE ONE STUDY)) is addressing this by testing a cell therapy approach aimed at improving organ acceptance. Within this project phase I clinical trials (safety phase) are being conducted in different EU states (Germany, UK, France, Italy) and the United States.
Thus far, THE ONE STUDY project has focused on establishing the necessary methods and protocols for cell manufacturing at leading research institutions around the world, as well as obtaining regulatory approval. Developed methods include a centralised immune monitoring programme and a cell-tracking technology.
Another important aspect of the project is experimental studies in animal models testing how different immune cells can contribute to immune suppression during organ transplantation.
Once THE ONE STUDY is complete, researchers will know whether cell-based therapy for improved organ acceptance is feasible. Research can then progress through phase II and III trials towards clinical application.