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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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, i 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]. 11.2020. [pristupljeno 21.12.2024.];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, Studeni 2020. [Online]. Dostupno na: https://urn.nsk.hr/urn:nbn:hr:105:822278. [Citirano: 21.12.2024.]

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Naslov (engleski)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
AutorDragan Đurdević
AutorTomislav Vlahović
AutorSanja Pehar
AutorDina Miklić
AutorHermann Oppermann
AutorTatjana Bordukalo-Nikšić
AutorIsmet Gavrankapetanović
AutorMehmed Jamakosmanović
AutorMilan Milošević
AutorSnježana Martinović
AutorT. Kuber Sampath
AutorMihaela Perić
AutorLovorka Grgurević
AutorSlobodan Vukičević
Autorova ustanovaSveučilište u Zagrebu
Medicinski fakultet
(KATEDRA ZA ANATOMIJU)
Autorova ustanovaSveučilište u Zagrebu
Medicinski fakultet
(KATEDRA ZA ZDRAVSTVENU EKOLOGIJU, MEDICINU RADA I SPORTA)
Znanstveno / umjetničko
područje, polje i grana		BIOMEDICINA I ZDRAVSTVO
Temeljne medicinske znanosti
Anatomija
Znanstveno / umjetničko
područje, polje i grana		BIOMEDICINA I ZDRAVSTVO
Javno zdravstvo i zdravstvena zaštita
Zdravstvena ekologija
Sažetak (engleski)
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.
Ključne riječi (engleski)
Jezikengleski
Vrsta publikacijeZnanstveni rad - Izvorni znanstveni rad
Status objaveObjavljen
Vrsta recenzijeRecenziran - međunarodna recenzija
Verzija publikacijeObjavljena verzija rada (izdavačev PDF)
Naslov časopisaBone
Brojčani podacivol. 140, 115551
p-ISSN8756-3282
e-ISSN1873-2763
DOIhttps://doi.org/10.1016/j.bone.2020.115551
URN:NBNurn:nbn:hr:105:822278
Datum objave publikacije2020-11
URL dokumentahttps://linkinghub.elsevier.com/retrieve/pii/S8756328220303318
Vrsta resursaTekst
Prava pristupaOtvoreni pristup
Uvjeti korištenjaIkona licence Imenovanje 4.0 međunarodna (CC BY 4.0)
Datum i vrijeme pohrane2021-04-29 08:52:39