NRT

Phase II clinical trial of PDGF-BB for the neurological regeneration and recovery in Parkinson´s disease

Coordinatore	NEWRON SWEDEN AB    more  Organization address address: FISKARTORPSVAGEN 15 A D city: STOCKHOLM postcode: 114 33 contact info Titolo: Dr. Nome: Anders Cognome: Haegerstrand Email: send email Telefono: +46 70 5755037 Fax: +46 8 7860922
Nazionalità Coordinatore	Sweden [SE]
Totale costo	8˙076˙589 €
EC contributo	5˙962˙457 €
Programma	FP7-HEALTH Specific Programme "Cooperation": Health
Code Call	FP7-HEALTH-2011-two-stage
Funding Scheme	CP-FP
Anno di inizio	2012
Periodo (anno-mese-giorno)	2012-01-01   -   2015-12-31

 Partecipanti

#	participant	country	role	EC contrib. [€]
1	NEWRON SWEDEN AB  Organization address address: FISKARTORPSVAGEN 15 A D city: STOCKHOLM postcode: 114 33 contact info Titolo: Dr. Nome: Anders Cognome: Haegerstrand Email: send email Telefono: +46 70 5755037 Fax: +46 8 7860922	SE (STOCKHOLM)	coordinator	3˙342˙524.80
2	LUNDS UNIVERSITET  Organization address address: Paradisgatan 5c city: LUND postcode: 22100 contact info Titolo: Prof. Nome: Patrik Cognome: Brundin Email: send email Telefono: +46 46 222 05 29 Fax: +46 46 222 05 31	SE (LUND)	participant	498˙849.60
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: Dr. Nome: Stephen Cognome: Conway Email: send email Telefono: +44 1865 289811 Fax: +44 1865 289801	UK (OXFORD)	participant	433˙483.30
4	SKANE LANS LANDSTING  Organization address city: KRISTIANSTAD postcode: 291 89 contact info Titolo: Prof. Nome: Håkan Cognome: Widner Email: send email Telefono: 4646171425 Fax: 4646158919	SE (KRISTIANSTAD)	participant	414˙402.00
5	STOCKHOLMS LAENS LANDSTING  Organization address address: Hantverkargatan 45 city: STOCKHOLM postcode: 104 22 contact info Titolo: Ms. Nome: Getrud Cognome: Ocklin Email: send email Telefono: +46 8 517 792 06	SE (STOCKHOLM)	participant	383˙661.20
6	KING'S COLLEGE HOSPITAL NHS TRUST  Organization address address: DENMARK HILL 1 city: LONDON postcode: SE5 9RS contact info Titolo: Ms. Nome: Kathryn Cognome: Huggins Email: send email Telefono: +44 3 299 9000	UK (LONDON)	participant	342˙760.40
7	KLINIKUM BREMERHAVEN-REINKENHEIDE GGMBH  Organization address address: POSTBROOKSTRASSE 103 city: BREMERHAVEN postcode: 27574 contact info Titolo: Ms. Nome: Sandra Cognome: Leimbach Email: send email Telefono: 494713000000 Fax: 494713000000	DE (BREMERHAVEN)	participant	224˙280.00
8	LIFE SCIENCE GOVERNANCE INSTITUTE  Organization address address: Schottenfeldgasse 29 city: vienna postcode: 1070 contact info Titolo: Ms. Nome: Ingrid Cognome: Metzler Email: send email Telefono: 69912668113	AT (vienna)	participant	168˙535.34
9	TONIC LIFE COMMUNICATIONS LIMITED  Organization address address: HUNTSWORTH MEWS 15-17 city: LONDON postcode: NW1 6DD contact info Titolo: Ms. Nome: Katherine Cognome: Diaz Email: send email Telefono: +44 20 7798 9908 Fax: +44 20 7233 8780	UK (LONDON)	participant	133˙562.50
10	ASSOCIATION EUROPEENNE POUR LA MALADIE DE PARKINSON  Organization address address: AVENUE NESTOR PLISSART 4 city: BRUXELLES postcode: 1040 contact info Titolo: Ms. Nome: Lizzie Cognome: Graham Email: send email Telefono: +44 207 8725510	BE (BRUXELLES)	participant	20˙398.63

Mappa

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 Obiettivo del progetto (Objective)

'The goal of this project is to perform a European phase II clinical trial to demonstrate that PDGF-BB acts as a unique regenerative therapy for Parkinson’s Disease (PD), aimed at reversing the course of the disease, by promotion of endogenous brain repair mechanisms. Current pharmacological therapies for PD carry side-effects and become less effective as the disease progresses. This causes immense suffering for patients in their daily lives. There is currently no established disease-modifying, regenerative or neuroprotective treatment for PD. Such a therapy would revolutionize the capacity to effectively treat PD patients and could dramatically reduce the multi-billion € annual cost to Europe. The project will conduct a multi-centre clinical trial in PD using intracerebroventricular administration of PDGF-BB. To obtain the most relevant information from the clinical trial, state-of-the-art disease rating scales and brain imaging technology will be used to monitor changes related to restoration of brain function. Planning and conduct of the clinical study will involve investigators and advisors with extensive expertise in the disease-area and experience with participating in clinical studies. To further advance the understanding of the regenerative mechanism, preclinical studies will be performed. We will set up a framework of partners to ensure proper governance of the clinical study, compliant with fundamental ethical principles of European regulations concerning studies on “advanced therapies medicinal products”. PD patient associations and experts in ethics will assist the project with patient information and recruitment strategies. Internal training sessions, external meetings and dissemination of results will be coordinated by a communication expert firm. A robust and realistic commercialization strategy including IP, health economy and reimbursement will be developed.'