Skip to main content

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

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”.

Call for proposal

H2020-SC1-2017-Single-Stage-RTD
See other projects for this call

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
Address
Svetonedjeljska 2
10436 Kalinovica
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Medizinische Universitaet Wien
Austria
EU contribution
€ 848 625
Address
Spitalgasse
A-1090 Vienna
Activity type
Higher or Secondary Education Establishments
UNIVERSITAT LINZ
Austria
EU contribution
€ 423 750
Address
Altenberger Strasse 69
4040 Linz
Activity type
Higher or Secondary Education Establishments
Medizinische Universitaet Graz
Austria
EU contribution
€ 347 500
Address
Auenbruggerplatz 2
8036 Graz
Activity type
Higher or Secondary Education Establishments
OPCA BOLNICA VARAZDIN

Participation ended

Croatia
EU contribution
€ 0
Address
Ivana Mestrovica 1
42000 Varazdin
Activity type
Other
PAUL REGULATORY SERVICES LIMITED

Participation ended

United Kingdom
EU contribution
€ 14 154
Address
Fisher Hill Way 15
CF15 8DR Cardiff
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
CLINRES FARMACIJA RAZISKAVE DOO
Slovenia
EU contribution
€ 705 762,50
Address
Slandrova Ulica 48
1231 Ljubljana
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
SMART-MEDICO DOO
Croatia
EU contribution
€ 253 532,50
Address
Zupanova 5
10000 Zagreb
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
TRIADELTA PARTNERI DOO ZA ISTRAZIVANJE I RAZVOJ
Croatia
EU contribution
€ 183 107,50
Address
Medimurska 19/2
10000 Zagreb Grad Zagreb
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
2KMM SPOLKA Z OGRANICZONA ODPOWIEDZIALNOSCIA
Poland
EU contribution
€ 377 250
Address
Ul Al W Korfantengo 79
40 161 Katowice
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
UNIVERSITY OF ZAGREB-FACULTY OF VETERINARY MEDICINE
Croatia
EU contribution
€ 251 250
Address
Heinzelova 55
10000 Zagreb
Activity type
Higher or Secondary Education Establishments
EURICE EUROPEAN RESEARCH AND PROJECT OFFICE GMBH
Germany
EU contribution
€ 454 375
Address
Heinrich-hertz-allee 1
66386 St Ingbert
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
QBEX GMBH
Austria
EU contribution
€ 295 346
Address
St. Veiter Ring 1A
9020 Klagenfurt
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)