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
city: REGENSBURG
postcode: 93053

contact info
Titolo: Ms.
Nome: Elisabeth
Cognome: Geiger
Email: send email
Telefono: +49 941 944 5785
Fax: +49 941 944 5899

 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

# participant  country  role  EC contrib. [€] 
1    KLINIKUM DER UNIVERSITAET REGENSBURG

 Organization address address: FRANZ JOSEF STRAUSS ALLEE 11
city: REGENSBURG
postcode: 93053

contact info
Titolo: Ms.
Nome: Elisabeth
Cognome: Geiger
Email: send email
Telefono: +49 941 944 5785
Fax: +49 941 944 5899

DE (REGENSBURG) coordinator 3˙620˙543.00
2    CHARITE - UNIVERSITAETSMEDIZIN BERLIN

 Organization address address: Chariteplatz 1
city: BERLIN
postcode: 10117

contact info
Titolo: Ms.
Nome: Eveline
Cognome: Fräßdorf
Email: send email
Telefono: +49 30 450 576024
Fax: +49 30 450 576954

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
city: OXFORD
postcode: OX1 2JD

contact info
Titolo: Ms.
Nome: Linda
Cognome: Polik
Email: send email
Telefono: +44 1865 289800
Fax: +44 1865 289801

UK (OXFORD) participant 1˙003˙922.00
4    KING'S COLLEGE LONDON

 Organization address address: Strand
city: LONDON
postcode: WC2R 2LS

contact info
Titolo: Mr.
Nome: Paul
Cognome: Labbett
Email: send email
Telefono: +44 2078488184
Fax: +44 2078488187

UK (LONDON) participant 960˙001.00
5    CENTRE HOSPITALIER UNIVERSITAIRE DE NANTES

 Organization address address: Allee de l'Ile Gloriette 5
city: NANTES
postcode: 44093

contact info
Titolo: Ms.
Nome: Anne
Cognome: Brethet
Email: send email
Telefono: +33 2 53 48 28 25
Fax: +33 2 53 48 28 26

FR (NANTES) participant 678˙000.00
6    MILTENYI BIOTEC GMBH

 Organization address address: FRIEDRICH EBERT STRASSE 68
city: BERGISCH GLADBACH
postcode: 51429

contact info
Titolo: Dr.
Nome: Michael
Cognome: Apel
Email: send email
Telefono: +49 2204 8306 4236
Fax: +49 2204 85197

DE (BERGISCH GLADBACH) participant 460˙000.00
7    THE REGENTS OF THE UNIVERSITY OF CALIFORNIA

 Organization address address: "FRANKLIN STREET 1111, 12 FLOOR"
city: OAKLAND CA
postcode: 94607

contact info
Titolo: Mr.
Nome: Kevin R.
Cognome: Kaier
Email: send email
Telefono: +1 415 278 070
Fax: +1 415 278 07 8

US (OAKLAND CA) participant 442˙387.60
8    Fondazione Centro San Raffaele

 Organization address address: Via Olgettina 60
city: Milano
postcode: 20132

contact info
Titolo: Dr.
Nome: Maria Rosa
Cognome: Pedrazzi
Email: send email
Telefono: +39 02 2643 4845
Fax: +39 02 2643 4717

IT (Milano) participant 387˙000.00
9    ALTA RICERCA E SVILUPPO IN BIOTECNOLOGIE SRLU

 Organization address address: VIA FIORENTINA 151
city: SIENA
postcode: 53100

contact info
Titolo: Ms.
Nome: Cristiana
Cognome: Tozzi
Email: send email
Telefono: +39 0577 587906
Fax: +39 0577 593815

IT (SIENA) participant 350˙000.00
10    CLINIT AG

 Organization address address: HORNUSSTRASSE 16
city: FREIBURG
postcode: 79108

contact info
Titolo: Ms.
Nome: Natascha
Cognome: Heifer
Email: send email
Telefono: +49 761 60318 613
Fax: +49 761 50318 7613

DE (FREIBURG) participant 314˙000.00
11    Electro Scientific Industries Europe Ltd.

 Organization address address: "Avro Court, Ermine Business Park 8"
city: Huntingdon
postcode: PE29 6XS

contact info
Titolo: Dr.
Nome: Damon
Cognome: Green
Email: send email
Telefono: +44 1480 456 566
Fax: +44 1480 456 545

UK (Huntingdon) participant 293˙760.00
12    UNIVERSITY OF WISCONSIN-MADISON

 Organization address address: 161 BASCAM HALL 500 LINCOLN DR.
city: WISCONSIN
postcode: WI 53706

contact info
Titolo: Mr.
Nome: Robert
Cognome: Andresen
Email: send email
Telefono: +1 608 262 2896
Fax: +1 608 262 5111

US (WISCONSIN) participant 200˙000.00
13    LOUGHBOROUGH UNIVERSITY

 Organization address address: Ashby Road
city: LOUGHBOROUGH
postcode: LE11 3TU

contact info
Titolo: Ms.
Nome: Louise
Cognome: Denniff
Email: send email
Telefono: +44 1509 22 2451
Fax: +44 1509 22 3953

UK (LOUGHBOROUGH) participant 154˙318.00
14    The General Hospital Corporation

 Organization address address: Fruit Street 55
city: "Boston, Massachusetts"
postcode: 2114

contact info
Titolo: Dr.
Nome: Anthony
Cognome: Cassese
Email: send email
Telefono: +1 617 9549589
Fax: +1 617 9549850

US ("Boston, Massachusetts") participant 140˙020.00
15    PHARMATCHING GMBH

 Organization address address: WIPPERTSTRASSE 2
city: FREIBURG IM BREISGAU
postcode: 79100

contact info
Titolo: Ms.
Nome: Sabine
Cognome: Kistner
Email: send email
Telefono: +49 761 13 73 44 20
Fax: +49 761 13 73 444

DE (FREIBURG IM BREISGAU) participant 32˙049.28
16    FONDAZIONE CENTRO SAN RAFFAELE DEL MONTE TABOR

 Organization address address: Via Olgettina 60
city: MILANO
postcode: 20132

contact info
Titolo: Mr.
Nome: Mario
Cognome: Valsecchi
Email: send email
Telefono: +39 02 26432729
Fax: +39 02 26432752

IT (MILANO) participant 0.00

Mappa


 Word cloud

Esplora la "nuvola delle parole (Word Cloud) per avere un'idea di massima del progetto.

feasible    safety    outcome    acceptance    pharmacological    transplant    types    single    recipients    clinical    therapy    cell    organ    reduce    organs    immune    health    immunosuppression    transplantation    efficacy    tolerance    promising    regulatory    solid    rejection    trials    society    cells   

 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.

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