Opendata, web and dolomites

BOOSTB4 SIGNED

Boost Brittle Bones Before Birth

Total Cost €

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EC-Contrib. €

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Partnership

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Project "BOOSTB4" data sheet

The following table provides information about the project.

Coordinator
KAROLINSKA INSTITUTET 

Organization address
address: Nobels Vag 5
city: STOCKHOLM
postcode: 17177
website: www.ki.se

contact info
title: n.a.
name: n.a.
surname: n.a.
function: n.a.
email: n.a.
telephone: n.a.
fax: n.a.

 Coordinator Country Sweden [SE]
 Total cost 8˙378˙755 €
 EC max contribution 6˙608˙754 € (79%)
 Programme 1. H2020-EU.3.1. (SOCIETAL CHALLENGES - Health, demographic change and well-being)
 Code Call H2020-PHC-2015-single-stage_RTD
 Funding Scheme /RIA
 Starting year 2016
 Duration (year-month-day) from 2016-01-01   to  2020-12-31

 Partnership

Take a look of project's partnership.

# participants  country  role  EC contrib. [€] 
1    KAROLINSKA INSTITUTET SE (STOCKHOLM) coordinator 1˙827˙061.00
2    GREAT ORMOND STREET HOSPITAL FOR CHILDREN NATIONAL HEALTH SERVICE TRUST UK (LONDON) participant 1˙410˙493.00
3    KLINIKUM DER UNIVERSITAET ZU KOELN DE (KOELN) participant 703˙132.00
4    UNIVERSITY COLLEGE LONDON UK (London) participant 648˙543.00
5    ACADEMISCH ZIEKENHUIS LEIDEN NL (LEIDEN) participant 568˙656.00
6    CELLPROTECT NORDIC PHARMACEUTICALS AB SE (Huddinge) participant 549˙781.00
7    EURAM LIMITED UK (LINCOLN) participant 281˙000.00
8    LUNDS UNIVERSITET SE (Lund) participant 241˙156.00
9    MEDSCINET AB SE (Stockholm) participant 121˙093.00
10    NORDIC HEALTH ECONOMICS AB SE (GOTEBORG) participant 106˙000.00
11    UNIVERSITAIR MEDISCH CENTRUM UTRECHT NL (UTRECHT) participant 101˙836.00
12    UNIVERSITY OF LEICESTER UK (LEICESTER) participant 50˙000.00

Mappa

 Project objective

Osteogenesis imperfecta (OI) is, in its severe forms, a devastating inherited disorder characterised by brittle bones. A person with severe OI is affected throughout their lifetime with repeated, multiple fractures, considerable pain and handicap. There is no curative or effective treatment for OI. Our preclinical studies and initial clinical cases have demonstrated that transplantation of fetal mesenchymal stem cells (MSC) is a promising approach for treatment of OI. We receive regular requests for MSC transplantation from patients and their physicians; patient organisations support our approach. The principal objective of the BOOSTB4 project is to conduct a Phase I/II clinical trial of the safety and efficacy of pre- and/or postnatal MSC transplantation in the severest forms of OI (type III, severe type IV). Transplantation before birth at the onset of disease should lead to greater efficacy and engraftment with less rejection than transplantation after birth. Postnatal transplantation will be evaluated in cases where prenatal diagnosis was not made. The trial’s primary outcome is safety; secondary outcomes relate to efficacy (fracture frequency, growth, bone mineral density and quality of life). All patients will undergo molecular diagnosis to confirm OI before inclusion in the trial. Non-invasive prenatal diagnosis will be developed and validated. The BOOSTB4 consortium is led by experts in MSC, prenatal therapy and OI at the Karolinska Institutet (KI), which will also lead the international multicentre trial; five additional EU centres of excellence are included. Ethical and regulatory applications are underway to conduct this clinical trial. These are facilitated by the ethical and regulatory approvals for prenatal MSC transplantation in 10 cases of OI that have already been granted at KI. Successful prenatal transplantation represents a major step forward in the management of patients with severe OI, and beyond, to a range of other inherited birth defects.

 Work performed, outcomes and results:  advancements report(s) 

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The information about "BOOSTB4" are provided by the European Opendata Portal: CORDIS opendata.

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