CORDIS
EU research results

CORDIS

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

Project information

Grant agreement ID: 779340

Status

Ongoing project

  • Start date

    1 January 2018

  • End date

    31 December 2022

Funded under:

H2020-EU.3.1.3.

  • Overall budget:

    € 6 004 152,50

  • EU contribution

    € 6 004 152,50

Coordinated by:

SVEUCILISTE U ZAGREBU MEDICINSKI FAKULTET

Croatia

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”.
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Coordinator

SVEUCILISTE U ZAGREBU MEDICINSKI FAKULTET

Address

Salata 3
10 000 Zagreb

Croatia

Activity type

Higher or Secondary Education Establishments

EU Contribution

€ 710 750

Participants (13)

GENERA ISTRAZIVANJA DRUSTVO S OGRANICENOM ODGOVORNOSCU ZA PROIZVODNJU BIOTEHNOLOSKIH PROIZVODA

Croatia

EU Contribution

€ 1 138 750

MEDIZINISCHE UNIVERSITAET WIEN

Austria

EU Contribution

€ 848 625

UNIVERSITAT LINZ

Austria

EU Contribution

€ 423 750

MEDIZINISCHE UNIVERSITAT GRAZ

Austria

EU Contribution

€ 347 500

OPCA BOLNICA VARAZDIN

Croatia

PAUL REGULATORY SERVICES LIMITED

United Kingdom

EU Contribution

€ 14 154

CLINRES FARMACIJA RAZISKAVE DOO

Slovenia

EU Contribution

€ 705 762,50

SMART-MEDICO DOO

Croatia

EU Contribution

€ 253 532,50

TRIADELTA PARTNERI DOO ZA ISTRAZIVANJE I RAZVOJ

Croatia

EU Contribution

€ 183 107,50

2KMM SPOLKA Z OGRANICZONA ODPOWIEDZIALNOSCIA

Poland

EU Contribution

€ 377 250

UNIVERSITY OF ZAGREB-FACULTY OF VETERINARY MEDICINE

Croatia

EU Contribution

€ 251 250

EURICE EUROPEAN RESEARCH AND PROJECT OFFICE GMBH

Germany

EU Contribution

€ 454 375

QBEX GMBH

Austria

EU Contribution

€ 295 346

Project information

Grant agreement ID: 779340

Status

Ongoing project

  • Start date

    1 January 2018

  • End date

    31 December 2022

Funded under:

H2020-EU.3.1.3.

  • Overall budget:

    € 6 004 152,50

  • EU contribution

    € 6 004 152,50

Coordinated by:

SVEUCILISTE U ZAGREBU MEDICINSKI FAKULTET

Croatia