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OSTEOproSPINE SIGNED

Novel Bone Regeneration Drug Osteogrow: Therapeutic Solution for Lumbar Back Pain

Total Cost €

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EC-Contrib. €

0

Partnership

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 OSTEOproSPINE project word cloud

Explore the words cloud of the OSTEOproSPINE project. It provides you a very rough idea of what is the project "OSTEOproSPINE" about.

autograft    extra    cells    ethics    vertebrae    crest    assembled    spine    excellent    site    osteogrow    suffering    protein    279239    molecular    13    randomized    resistant    coagulum    patients    centers    tibial    human    replace    humans    blinded    evaluation    correct    rhbmp6    180    weight    bearing    disease    supporting    conduct    trials    radius    permissive    disorders    population    clinical    presumptive    regenerative    pain    lumbar    health    profile    harvested    disc    recombinant    medicine    standard    confirm    iliac    fp7    reduce    chronic    morphogenetic    spinal    vienna    ground    skeletal    microenvironment    surgery    rate    quality    compression    generating    fracture    posterolateral    conditional    osteotomy    outcome    delivered    reinforced    trial    intractable    committee    fusion    evaluator    guide    exhibited    efficacy    form    distal    allograft    positive    life    designed    enroll    matrix    blood    restore    safety    function    autologous    severity    patient    therapy    bone    signals    regeneration    treatment    care    osteoprospine    degenerative    back    granted    administration    approval    peripheral    grant    functioning   

Project "OSTEOproSPINE" data sheet

The following table provides information about the project.

Coordinator
SVEUCILISTE U ZAGREBU MEDICINSKI FAKULTET 

Organization address
address: SALATA 3
city: ZAGREB
postcode: 10 000
website: www.mef.unizg.hr

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 Croatia [HR]
 Total cost 6˙004˙152 €
 EC max contribution 6˙004˙152 € (100%)
 Programme 1. H2020-EU.3.1.3. (Treating and managing disease)
 Code Call H2020-SC1-2017-Single-Stage-RTD
 Funding Scheme RIA
 Starting year 2018
 Duration (year-month-day) from 2018-01-01   to  2022-12-31

 Partnership

Take a look of project's partnership.

# participants  country  role  EC contrib. [€] 
1    SVEUCILISTE U ZAGREBU MEDICINSKI FAKULTET HR (ZAGREB) coordinator 710˙750.00
2    GENERA ISTRAZIVANJA DRUSTVO S OGRANICENOM ODGOVORNOSCU ZA PROIZVODNJU BIOTEHNOLOSKIH PROIZVODA HR (KALINOVICA) participant 1˙138˙750.00
3    MEDIZINISCHE UNIVERSITAET WIEN AT (WIEN) participant 848˙625.00
4    CLINRES FARMACIJA RAZISKAVE DOO SI (LJUBLJANA) participant 705˙762.00
5    EURICE EUROPEAN RESEARCH AND PROJECT OFFICE GMBH DE (ST INGBERT) participant 454˙375.00
6    UNIVERSITAT LINZ AT (LINZ) participant 423˙750.00
7    2KMM SPOLKA Z OGRANICZONA ODPOWIEDZIALNOSCIA PL (KATOWICE) participant 377˙250.00
8    MEDIZINISCHE UNIVERSITAT GRAZ AT (GRAZ) participant 347˙500.00
9    QBEX GMBH AT (KLAGENFURT) participant 295˙346.00
10    SMART-MEDICO DOO HR (ZAGREB) participant 253˙532.00
11    UNIVERSITY OF ZAGREB-FACULTY OF VETERINARY MEDICINE HR (ZAGREB) participant 251˙250.00
12    TRIADELTA PARTNERI DOO ZA ISTRAZIVANJE I RAZVOJ HR (ZAGREB GRAD ZAGREB) participant 183˙107.00
13    PAUL REGULATORY SERVICES LIMITED UK (CARDIFF) participant 14˙154.00
14    OPCA BOLNICA VARAZDIN HR (VARAZDIN) participant 0.00

Map

 Project objective

We propose a clinical program for the evaluation of a novel bone-regeneration product OSTEOproSPINE as a treatment for intractable chronic back pain. OSTEOproSPINE is a novel bone regeneration therapy composed of OSTEOGROW (recombinant human bone morphogenetic protein 6 [rhBMP6] delivered in autologous peripheral blood coagulum) reinforced with allograft (a compression resistant matrix). OSTEOproSPINE is designed to guide the formation of new bone at extra-skeletal site and replace autograft harvested from patient’s iliac crest for the fusion of lumbar vertebrae. By generating new bone, OSTEOproSPINE will restore the spine’s weight bearing function, reduce the severity of back pain and improve the success rate of posterolateral spinal fusion surgery. The program consortium of 13 partners from 6 EU member states has been assembled to conduct a Phase II, randomized, patient- and evaluator-blinded clinical trial of OSTEOproSPINE. Four clinical centers will enroll 180 patients suffering from degenerative disc disease to assess OSTEOproSPINE efficacy and safety in comparison with Standard of care (autograft) and Osteogrow. The Ethics Committee of the leading clinical site in Vienna has already granted a conditional approval for this trial. As the coordinating institution of the FP7 HEALTH project Osteogrow (Grant No. 279239), we have evaluated Osteogrow in Phase I/II clinical trials for distal radius fracture and high tibial osteotomy. Osteogrow exhibited excellent safety profile in these trials, supporting OSTEOproSPINE safety for administration in humans. A positive outcome of proposed trial will confirm OSTEOproSPINE potential to form a functioning new bone in human and by this restore the spine’s function and improve the quality of life in patients with degenerative disc disorders using the ground principle of regenerative medicine: “provide the correct molecular signals to a population of presumptive cells in a permissive microenvironment”.

 Deliverables

List of deliverables.
Data Management Plan Open Research Data Pilot 2019-10-03 18:11:11
Public project website Websites, patent fillings, videos etc. 2019-10-03 18:11:11

Take a look to the deliverables list in detail:  detailed list of OSTEOproSPINE deliverables.

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

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