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Novel Bone Morphogenetic Protein-6 Biocompatible Carrier Device for Bone Regeneration
Start date:2012-01-01
End date:2016-06-30
Project Acronym:OSTEOGROW
Project status:Execution
Coordinator
| Organization name:SVEUCILISTE U ZAGREBU, MEDICINSKI FAKULTET | |
| Administrative contact | Address |
|
Name:Smiljka |
SALATA 3 ZAGREB Hrvatska Region: |
| Tel:+385-14566972 | |
| Fax:+385-14566724 | |
| E-mail:Contact | |
| URL: | Organization Type: |
Description
Objective:
Goals: We propose a regenerative medicine clinical trial of the therapeutic system OSTEOGROW for regenerating bone through harnessing a novel bone device to accelerate and enhance bone repair.
The osteogenic device is composed of an autologous carrier and a biologically active recombinant human protein offering a therapeutic solution in bone regeneration superior to currently available options.
The autologous carrier is a whole blood-derived coagulum device (WBCD) from the peripheral blood of a patient, which will act as an endogenous biocompatible material causing significantly less inflammatory reactions than currently used bone devices.
The bone inducing molecule is the recombinant human bone morphogenetic protein 6 (BMP6) which binds to WBCD and is more potent than other BMPs in stimulating bone formation in preclinical animal models. The consortium members will scale-up the production of BMP6 from an already developed working cell bank to enter clinical trials on bone regeneration.
The bone diseases we will treat locally with OSTEOGROW are acute radius fractures and recalcitrant non-unions of the tibia. These conditions are widespread and highly debilitating diseases for which such therapy holds great promise.
Workflow: Preliminary pre-clinical data are already available, and clinical grade (GMP) BMP6 will be available before the beginning of the project to perform toxicology studies and to determine the final formulation of OSTEOGROW. Clinical trials will start within 18 months from the start of the project funding.
Business strategy: SMEs Genera Research and BioTest will develop and validate the BMP6 production in their facilities. Consortium members from Medical University of Vienna, Sarajevo University Clinical Centre, Linkoping University Faculty of Health Sciences, Zagreb University Trauma Clinic, SMART Medico and Paul Regulatory Services will perform, monitor and coordinate clinical trials. OSTEOGROW will find a wide use in human and veterinary medicine.
Achievements:
General information:
Project Details
Start date:2012-01-01
End date:2016-06-30
Duration:54 months
Project Reference:279239
Project cost:7384746 EURO
Project Funding:5683089 EURO
Programme Acronym:
FP7-HEALTH
Programme type:Seventh Framework Programme
Subprogramme Area:Regenerative medicine clinical trials
Contract type:Small or medium-scale focused research project
URL:http://osteogrow.eu/
Subject index:Life Sciences
Other participants
| Organization name:EUROPEAN RESEARCH AND PROJECT OFFICE GMBH | |
| Administrative contact | Address |
|
Name:Claudia |
Science Park Saar, Stuhlsatzenhausweg 69 SAARBRUECKEN DEUTSCHLAND Region:SAARLAND Saarland Stadtverband Saarbrücken |
| Tel:+49-681-95923378 | |
| Fax:+49-681-95923370 | |
| E-mail:Contact | |
| URL:http://www.eurice.eu | Organization Type: |
| Organization name:LINKOPINGS UNIVERSITET | |
| Administrative contact | Address |
|
Name:Per |
CAMPUS VALLA LINKOPING SVERIGE Region: |
| Tel:+46-13224166 | |
| Fax: | |
| E-mail:Contact | |
| URL:http://www.liu.se | Organization Type:Education |
| Organization name:MEDIZINISCHE UNIVERSITAET WIEN | |
| Administrative contact | Address |
|
Name:Reinhard |
SPITALGASSE 23 WIEN ÖSTERREICH Region:OSTÖSTERREICH WIEN |
| Tel:+43-1404004084 | |
| Fax:+43-1404004029 | |
| E-mail:Contact | |
| URL:http://www.meduniwien.ac.at | Organization Type: |
| Organization name:MEDITOX S.R.O | |
| Administrative contact | Address |
|
Name:Martin |
POD ZAMKEM 279 KONAROVICE CESKA REPUBLIKA Region:CESKA REPUBLIKA STREDNI CECHY Stredocesky |
| Tel:+420-313129375 | |
| Fax:+420-313129366 | |
| E-mail:Contact | |
| URL:http://www.biotest.eu | Organization Type: |
| Organization name:KLINICKI BOLNICKI CENTAR SESTRE MILOSRDNICE USTANOVA | |
| Administrative contact | Address |
|
Name:Dragan |
VINOGRADSKA CESTA 29 ZAGREB Hrvatska Region: |
| Tel:+358-98235554 | |
| Fax: | |
| E-mail:Contact | |
| URL:http://www.trauma.hr | Organization Type: |
| Organization name:SGS VITROLOGY LIMITED | |
| Administrative contact | Address |
|
Name:Archie |
SOUTH AVENUE 5 CLYDEBANK GLASCOW UNITED KINGDOM Region: |
| Tel:+44-1419520022 | |
| Fax: | |
| E-mail:Contact | |
| URL:http://www.vitrologybiotech.com | Organization Type: |
| Organization name:GENERA ISTRAZIVANJA DRUSTVO S OGRANICENOM ODGOVORNOSCU ZA PROIZVODNJU BIOTEHNOLOSKIH PROIZVODA | |
| Administrative contact | Address |
|
Name:Hermann |
SVETONEDJELJSKA 2 KALINOVICA Hrvatska Region: |
| Tel:+385-13388761 | |
| Fax: | |
| E-mail:Contact | |
| URL: | Organization Type: |
| Organization name:KLINICKI CENTAR UNIVERZITETA U SARAJEVU | |
| Administrative contact | Address |
|
Name:Lilijana |
BOLNICKA 25 71000 SARAJEVO BOSNIA AND HERZEGOVINA Region: |
| Tel:+387-33668415 | |
| Fax:+387-33668415 | |
| E-mail:Contact | |
| URL:http://www.kcus.ba | Organization Type: |
| Organization name:PAUL REGULATORY SERVICES LIMITED | |
| Administrative contact | Address |
|
Name:Ruth |
FISHER HILL WAY 15 CARDIFF UNITED KINGDOM Region:WALES GWENT, MID-SOUTH-WEST GLAMORGAN South Glamorgan |
| Tel:+44-2920844647 | |
| Fax: | |
| E-mail:Contact | |
| URL: | Organization Type: |
| Organization name:SMART-MEDICO DOO | |
| Administrative contact | Address |
|
Name:Snjezana |
PRISAVLJE 8 ZAGREB Hrvatska Region: |
| Tel:+385-12446534 | |
| Fax:+385-12446534 | |
| E-mail:Contact | |
| URL:http://www.smart-medico.hr | Organization Type: |
Record control number:101812
