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Financement de l’UE (6 004 153 €) : Nouveau médicament de régénération osseuse Osteogrow : solution thérapeutique pour les maux de dos lombaires Hor01/01/2018 Programme de recherche et d'innovation de l'UE « Horizon »
Vue d’ensemble
Texte
Nouveau médicament de régénération osseuse Osteogrow : solution thérapeutique pour les maux de dos lombaires
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 12 partners from 5 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 143 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”.
| 2KMM sp. z o.o. | 377 250 € |
| Clinres Farmacija Raziskave d.o.o. | 705 763 € |
| Eurice European Research AND Project Office GmbH | 445 000 € |
| Genera Istrazivanja d.o.o. | 1 138 750 € |
| Kepler Universitatsklinikum GmbH | 0,00 € |
| Medizinische Universitaet Wien | 950 207 € |
| Medizinische Universitat Graz | 322 042 € |
| Opca Bolnica Varazdin | 0,00 € |
| Paul Regulatory Services Ltd. | 14 154,00 € |
| Qbex GmbH | 275 346 € |
| Smart-Medico d.o.o. | 253 533 € |
| Sveuciliste U Zagrebu Medicinski Fakultet | 720 125 € |
| Triadelta Partneri d.o.o. | 183 108 € |
| Universitat Linz | 382 626 € |
| University OF Zagreb-Faculty OF Veterinary Medicine | 236 250 € |
https://cordis.europa.eu/project/id/779340
Cette annonce se réfère à une date antérieure et ne reflète pas nécessairement l’état actuel.
