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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. €

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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.

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

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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