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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.

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

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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