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Pregled bibliografske jedinice broj: 1192495

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


Durdevic, Dragan; Vlahovic, Tomislav; Pehar, Sanja; Miklic, Dina; Oppermann, Hermann; Bordukalo-Niksic, Tatjana; Gavrankapetanovic, Ismet; Jamakosmanovic, Mehmed; Milosevic, Milan; Martinovic, Snjezana 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), 1-10 doi:10.1016/j.bone.2020.115551 (međunarodna recenzija, članak, znanstveni)


CROSBI ID: 1192495 Za ispravke kontaktirajte CROSBI podršku putem web obrasca

Naslov
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

Autori
Durdevic, Dragan ; Vlahovic, Tomislav ; Pehar, Sanja ; Miklic, Dina ; Oppermann, Hermann ; Bordukalo-Niksic, Tatjana ; Gavrankapetanovic, Ismet ; Jamakosmanovic, Mehmed ; Milosevic, Milan ; Martinovic, Snjezana ; Sampath, T. Kuber ; Peric, Mihaela ; Grgurevic, Lovorka ; Vukicevic, Slobodan

Izvornik
Bone (8756-3282) 140 (2020); 1-10

Vrsta, podvrsta i kategorija rada
Radovi u časopisima, članak, znanstveni

Ključne riječi
BMPs ; Clinical trials ; Implants ; Injury/fracture healing.

Sažetak
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.

Izvorni jezik
Engleski

Znanstvena područja
Temeljne medicinske znanosti



POVEZANOST RADA


Projekti:
EK-H2020-779340 - Novel Bone Regeneration Drug Osteogrow: Therapeutic Solution for Lumbar Back Pain (OSTEOproSPINE) (Vukičević, Slobodan, EK - H2020-SC1-2017-Single-Stage-RTD) ( POIROT)

Ustanove:
Medicinski fakultet, Zagreb,
KBC "Sestre Milosrdnice"

Poveznice na cjeloviti tekst rada:

doi

Citiraj ovu publikaciju:

Durdevic, Dragan; Vlahovic, Tomislav; Pehar, Sanja; Miklic, Dina; Oppermann, Hermann; Bordukalo-Niksic, Tatjana; Gavrankapetanovic, Ismet; Jamakosmanovic, Mehmed; Milosevic, Milan; Martinovic, Snjezana 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), 1-10 doi:10.1016/j.bone.2020.115551 (međunarodna recenzija, članak, znanstveni)
Durdevic, D., Vlahovic, T., Pehar, S., Miklic, D., Oppermann, H., Bordukalo-Niksic, T., Gavrankapetanovic, I., Jamakosmanovic, M., Milosevic, M. & Martinovic, 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, 1-10 doi:10.1016/j.bone.2020.115551.
@article{article, author = {Durdevic, Dragan and Vlahovic, Tomislav and Pehar, Sanja and Miklic, Dina and Oppermann, Hermann and Bordukalo-Niksic, Tatjana and Gavrankapetanovic, Ismet and Jamakosmanovic, Mehmed and Milosevic, Milan and Martinovic, Snjezana and Sampath, T. Kuber and Peric, Mihaela and Grgurevic, Lovorka and Vukicevic, Slobodan}, year = {2020}, pages = {1-10}, DOI = {10.1016/j.bone.2020.115551}, keywords = {BMPs, Clinical trials, Implants, Injury/fracture healing.}, journal = {Bone}, doi = {10.1016/j.bone.2020.115551}, volume = {140}, issn = {8756-3282}, title = {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}, keyword = {BMPs, Clinical trials, Implants, Injury/fracture healing.} }
@article{article, author = {Durdevic, Dragan and Vlahovic, Tomislav and Pehar, Sanja and Miklic, Dina and Oppermann, Hermann and Bordukalo-Niksic, Tatjana and Gavrankapetanovic, Ismet and Jamakosmanovic, Mehmed and Milosevic, Milan and Martinovic, Snjezana and Sampath, T. Kuber and Peric, Mihaela and Grgurevic, Lovorka and Vukicevic, Slobodan}, year = {2020}, pages = {1-10}, DOI = {10.1016/j.bone.2020.115551}, keywords = {BMPs, Clinical trials, Implants, Injury/fracture healing.}, journal = {Bone}, doi = {10.1016/j.bone.2020.115551}, volume = {140}, issn = {8756-3282}, title = {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}, keyword = {BMPs, Clinical trials, Implants, Injury/fracture healing.} }

Časopis indeksira:


  • Current Contents Connect (CCC)
  • Web of Science Core Collection (WoSCC)
    • Science Citation Index Expanded (SCI-EXP)
    • SCI-EXP, SSCI i/ili A&HCI
  • Scopus
  • MEDLINE


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