prikaz prve stranice dokumenta A novel autologous bone graft substitute comprised of rhBMP6 blood coagulum as carrier tested in a randomized and controlled Phase I trial in patients with distal radial fractures
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Scientific paper - Original scientific paper
A novel autologous bone graft substitute comprised of rhBMP6 blood coagulum as carrier tested in a randomized and controlled Phase I trial in patients with distal radial fractures
Bone, 140 (2020); 115551. https://doi.org/10.1016/j.bone.2020.115551
Đurdević, Dragan; Vlahović, Tomislav; Pehar, Sanja; Miklić, Dina; Oppermann, Hermann; Bordukalo-Nikšić, Tatjana; Gavrankapetanović, Ismet; Jamakosmanović, Mehmed; Milošević, Milan; Martinović, Snježana; Sampath, T. Kuber; Perić, Mihaela; Grgurević, Lovorka; Vukičević, Slobodan

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Đurdević, D., Vlahović, T., Pehar, S., Miklić, D., Oppermann, H., Bordukalo Nikšić, T. ... Vukičević, S. (2020). A novel autologous bone graft substitute comprised of rhBMP6 blood coagulum as carrier tested in a randomized and controlled Phase I trial in patients with distal radial fractures. Bone, 140.. doi: 10.1016/j.bone.2020.115551

Đurdević, Dragan, et al. "A novel autologous bone graft substitute comprised of rhBMP6 blood coagulum as carrier tested in a randomized and controlled Phase I trial in patients with distal radial fractures." Bone, vol. 140, 2020. https://doi.org/10.1016/j.bone.2020.115551

Đurdević, Dragan, Tomislav Vlahović, Sanja Pehar, Dina Miklić, Hermann Oppermann, Tatjana Bordukalo Nikšić, Ismet Gavrankapetanović, et al. "A novel autologous bone graft substitute comprised of rhBMP6 blood coagulum as carrier tested in a randomized and controlled Phase I trial in patients with distal radial fractures." Bone 140 (2020). https://doi.org/10.1016/j.bone.2020.115551

Đurdević, D., et al. (2020) 'A novel autologous bone graft substitute comprised of rhBMP6 blood coagulum as carrier tested in a randomized and controlled Phase I trial in patients with distal radial fractures', Bone, 140. doi: 10.1016/j.bone.2020.115551

Đurdević D, Vlahović T, Pehar S, Miklić D, Oppermann H, Bordukalo Nikšić T, and sur.. A novel autologous bone graft substitute comprised of rhBMP6 blood coagulum as carrier tested in a randomized and controlled Phase I trial in patients with distal radial fractures. Bone [Internet]. 2020 November [cited 2025 April 07];140. doi: 10.1016/j.bone.2020.115551

D. Đurdević, et al., "A novel autologous bone graft substitute comprised of rhBMP6 blood coagulum as carrier tested in a randomized and controlled Phase I trial in patients with distal radial fractures", Bone, vol. 140, November 2020. [Online]. Available at: https://urn.nsk.hr/urn:nbn:hr:105:822278. [Accessed: 07 April 2025]

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Title (english)A novel autologous bone graft substitute comprised of rhBMP6 blood coagulum as carrier tested in a randomized and controlled Phase I trial in patients with distal radial fractures
AuthorDragan Đurdević
AuthorTomislav Vlahović
AuthorSanja Pehar
AuthorDina Miklić
AuthorHermann Oppermann
AuthorTatjana Bordukalo-Nikšić
AuthorIsmet Gavrankapetanović
AuthorMehmed Jamakosmanović
AuthorMilan Milošević
AuthorSnježana Martinović
AuthorT. Kuber Sampath
AuthorMihaela Perić
AuthorLovorka Grgurević
AuthorSlobodan Vukičević
Author's institutionUniversity of Zagreb
School of Medicine
(Department of Anatomy and Clinical Anatomy)
Author's institutionUniversity of Zagreb
School of Medicine
(Department of Environmental and Occupational Health)
Scientific / art field,
discipline and subdiscipline		BIOMEDICINE AND HEALTHCARE
Basic Medical Sciences
Anatomy
Scientific / art field,
discipline and subdiscipline		BIOMEDICINE AND HEALTHCARE
Public Health and Health Care
Health Ecology
Abstract (english)
Bone morphogenetic proteins (BMPs) are known to induce new bone formation in vivo but treating trabecular bone defects with a BMP based therapeutic remains controversial. Here, we evaluated the safety and efficacy of a novel Autologous Bone Graft Substitute (ABGS) comprised of recombinant human BMP6 (rhBMP6) dispersed within an autologous blood coagulum (ABC) as a physiological natural carrier in patients with a closed distal radial fracture (DRF). We enrolled 32 patients in a randomized, standard of care (SoC) and placebo (PBO) controlled, double-blinded Phase I First in Human (FiH) clinical trial. ABGS was prepared from peripheral blood as 250 μg rhBMP6/mL ABC or PBO (1 mL ABC containing excipients only) and was administered dorsally via a syringe injection into the fracture site following closed fracture fixation with 3 Kirschner wires. Patients carried an immobilization for 5 weeks and were followed-up for 0 to 26 weeks by clinical examination, safety, serial radiographic analyses and CT. During the 13 weeks follow-up and at 26 weeks post study there were no serious adverse reactions recorded. The results showed that there were no detectable anti-rhBMP6 antibodies in the blood of any of the 32 patients at 13- and 26-weeks following treatment. Pharmacokinetic analyses of plasma from patients treated with ABGS showed no detectable rhBMP6 at any time point within the first 24 h following administration. The CT image and radiographic analyses score from patients treated with AGBS showed significantly accelerated bone healing as compared to PBO and SoC at 5 and 9 weeks (with high effect sizes and P = 0.027), while at week 13 all patients had similar healing outcomes. In conclusion, we show that intraosseous administration of ABGS (250 μg rhBMP6/mL ABC) into the distal radial fracture site demonstrated a good tolerability with no serious adverse reactions as well as early accelerated trabecular bone healing as compared to control PBO and SoC patients.
Keywords (english)
Languageenglish
Publication typeScientific paper - Original scientific paper
Publication statusPublished
Peer reviewPeer review - international
Publication versionPublished version
Journal titleBone
Numberingvol. 140, 115551
p-ISSN8756-3282
e-ISSN1873-2763
DOIhttps://doi.org/10.1016/j.bone.2020.115551
URN:NBNurn:nbn:hr:105:822278
Publication2020-11
Document URLhttps://linkinghub.elsevier.com/retrieve/pii/S8756328220303318
Type of resourceText
Access conditionsOpen access
Terms of useLicence Attribution 4.0 International (CC BY 4.0) icon
Created on2021-04-29 08:52:39