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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.

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

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 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.	HR (ZAGREB)	coordinator	710˙750.00
2	GENERA ISTRAZIVANJA DRUSTVO S OGRANICENOM ODGOVORNOSCU ZA PROIZVODNJU BIOTEHNOLOSKIH PROIZVODA GENERA ISTRAZIVANJA DRUSTVO S OGRANICENOM ODGOVORNOSCU ZA PROIZVODNJU BIOTEHNOLOSKIH PROIZVODA Organization address address: SVETONEDJELJSKA 2 city: KALINOVICA postcode: 10436 website: n.a. contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	HR (KALINOVICA)	participant	1˙138˙750.00
3	MEDIZINISCHE UNIVERSITAET WIEN MEDIZINISCHE UNIVERSITAET WIEN Organization address address: SPITALGASSE 23 city: WIEN postcode: 1090 website: www.meduniwien.ac.at contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	AT (WIEN)	participant	848˙625.00
4	CLINRES FARMACIJA RAZISKAVE DOO CLINRES FARMACIJA RAZISKAVE DOO Organization address address: VILHARJEVA CESTA 29 city: LJUBLJANA postcode: 1000 website: n.a. contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	SI (LJUBLJANA)	participant	705˙762.00
5	EURICE EUROPEAN RESEARCH AND PROJECT OFFICE GMBH EURICE EUROPEAN RESEARCH AND PROJECT OFFICE GMBH Organization address address: HEINRICH-HERTZ-ALLEE 1 city: ST INGBERT postcode: 66386 website: www.eurice.eu contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	DE (ST INGBERT)	participant	454˙375.00
6	UNIVERSITAT LINZ UNIVERSITAT LINZ Organization address address: ALTENBERGER STRASSE 69 city: LINZ postcode: 4040 website: www.jku.at contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	AT (LINZ)	participant	423˙750.00
7	2KMM SPOLKA Z OGRANICZONA ODPOWIEDZIALNOSCIA 2KMM SPOLKA Z OGRANICZONA ODPOWIEDZIALNOSCIA Organization address address: UL AL W KORFANTENGO 79 city: KATOWICE postcode: 40 161 website: n.a. contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	PL (KATOWICE)	participant	377˙250.00
8	MEDIZINISCHE UNIVERSITAT GRAZ MEDIZINISCHE UNIVERSITAT GRAZ Organization address address: AUENBRUGGERPLATZ 2 city: GRAZ postcode: 8036 website: http://www.medunigraz.at contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	AT (GRAZ)	participant	347˙500.00
9	QBEX GMBH QBEX GMBH Organization address address: ST. VEITER RING 1A city: KLAGENFURT postcode: 9020 website: n.a. contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	AT (KLAGENFURT)	participant	295˙346.00
10	SMART-MEDICO DOO SMART-MEDICO DOO Organization address address: ZUPANOVA 5 city: ZAGREB postcode: 10000 website: www.smart-medico.hr contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	HR (ZAGREB)	participant	253˙532.00
11	UNIVERSITY OF ZAGREB-FACULTY OF VETERINARY MEDICINE UNIVERSITY OF ZAGREB-FACULTY OF VETERINARY MEDICINE Organization address address: HEINZELOVA 55 city: ZAGREB postcode: 10000 website: www.vef.hr contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	HR (ZAGREB)	participant	251˙250.00
12	TRIADELTA PARTNERI DOO ZA ISTRAZIVANJE I RAZVOJ TRIADELTA PARTNERI DOO ZA ISTRAZIVANJE I RAZVOJ Organization address address: MEDIMURSKA 19/2 city: ZAGREB GRAD ZAGREB postcode: 10000 website: n.a. contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	HR (ZAGREB GRAD ZAGREB)	participant	183˙107.00
13	PAUL REGULATORY SERVICES LIMITED PAUL REGULATORY SERVICES LIMITED Organization address address: FISHER HILL WAY 15 city: CARDIFF postcode: CF15 8DR website: n.a. contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	UK (CARDIFF)	participant	14˙154.00
14	OPCA BOLNICA VARAZDIN OPCA BOLNICA VARAZDIN Organization address address: IVANA MESTROVICA 1 city: VARAZDIN postcode: 42000 website: n.a. contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	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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