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Pregled bibliografske jedinice broj: 1192497

Recombinant Human <scp>BMP6</scp> Applied Within Autologous Blood Coagulum Accelerates Bone Healing: Randomized Controlled Trial in High Tibial Osteotomy Patients


Chiari, Catharina; Grgurevic, Lovorka; Bordukalo‐Niksic, Tatjana; Oppermann, Hermann; Valentinitsch, Alexander; Nemecek, Elena; Staats, Kevin; Schreiner, Markus; Trost, Carmen; Kolb, Alexander et al.
Recombinant Human BMP6 Applied Within Autologous Blood Coagulum Accelerates Bone Healing: Randomized Controlled Trial in High Tibial Osteotomy Patients // Journal of Bone and Mineral Research, 35 (2020), 10; 1893-1903 doi:10.1002/jbmr.4107 (međunarodna recenzija, članak, znanstveni)


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Naslov
Recombinant Human <scp>BMP6</scp> Applied Within Autologous Blood Coagulum Accelerates Bone Healing: Randomized Controlled Trial in High Tibial Osteotomy Patients

Autori
Chiari, Catharina ; Grgurevic, Lovorka ; Bordukalo‐Niksic, Tatjana ; Oppermann, Hermann ; Valentinitsch, Alexander ; Nemecek, Elena ; Staats, Kevin ; Schreiner, Markus ; Trost, Carmen ; Kolb, Alexander ; Kainberger, Franz ; Pehar, Sanja ; Milosevic, Milan ; Martinovic, Snjezana ; Peric, Mihaela ; Sampath, T Kuber ; Vukicevic, Slobodan ; Windhager, Reinhard

Izvornik
Journal of Bone and Mineral Research (0884-0431) 35 (2020), 10; 1893-1903

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

Ključne riječi
BMP ; CLINICAL TRIALS ; IMPLANTS ; INJURY/FRACTURE HEALING.

Sažetak
Bone morphogenetic proteins (BMPs) are potent osteogenic proteins that induce new bone formation in vivo. However, their effect on bone healing in the trabecular bone surfaces remains challenging. We evaluated the safety and efficacy of recombinant human BMP6 (rhBMP6) applied within an autologous blood coagulum (ABC) in a surgically created wedge defect of the proximal tibia in patients undergoing high tibial osteotomy (HTO) for varus deformity and medial osteoarthritis of the knee. We enrolled 20 HTO patients in a randomized, placebo-controlled, double-blinded phase I/II clinical trial. RhBMP6/ABC (1.0 mg/10 mL ABC prepared from peripheral blood) or placebo (10 mL ABC containing excipients) was administered into the tibial wedge defects. Patients were followed for 0 to 24 months by clinical examination (safety) and computed tomography (CT) and serial radiographic analyses (efficacy). The results show that there were no detectable anti- rhBMP6 antibodies in the blood of any of the 20 patients at 14 weeks after implantation. During the 24 months of follow-up, there were no serious adverse reactions recorded. The CT scans from defects of patients treated with rhBMP6/ABC showed an accelerated bone healing compared with placebo at 9 weeks (47.8 ± 24.1 versus 22.2 ± 12.3 mg/cm3 ; p = 0.008) and at 14 weeks (89.7 ± 29.1 versus 53.6 ± 21.9 mg/cm3 ; p = 0.006) follow-up. Radiographic analyses at weeks 6 and 24 and months 12 and 24 suggested the advanced bone formation and remodeling in rhBMP6/ABC-treated patients. In conclusion, we show that rhBMP6/ABC at a dose of 100 μg/mL accelerated bone healing in patients undergoing HTO without serious adverse events and with a good tolerability compared with placebo alone. Overall, for the first time, a BMP-based osteogenic implant was examined against a placebo for bone healing efficacy in the trabecular bone surface, using an objective bone mineral density measurement system. © 2020 The Authors. Journal of Bone and Mineral Research published by American Society for Bone and Mineral Research.

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

Poveznice na cjeloviti tekst rada:

doi

Citiraj ovu publikaciju:

Chiari, Catharina; Grgurevic, Lovorka; Bordukalo‐Niksic, Tatjana; Oppermann, Hermann; Valentinitsch, Alexander; Nemecek, Elena; Staats, Kevin; Schreiner, Markus; Trost, Carmen; Kolb, Alexander et al.
Recombinant Human BMP6 Applied Within Autologous Blood Coagulum Accelerates Bone Healing: Randomized Controlled Trial in High Tibial Osteotomy Patients // Journal of Bone and Mineral Research, 35 (2020), 10; 1893-1903 doi:10.1002/jbmr.4107 (međunarodna recenzija, članak, znanstveni)
Chiari, C., Grgurevic, L., Bordukalo‐Niksic, T., Oppermann, H., Valentinitsch, A., Nemecek, E., Staats, K., Schreiner, M., Trost, C. & Kolb, A. (2020) Recombinant Human BMP6 Applied Within Autologous Blood Coagulum Accelerates Bone Healing: Randomized Controlled Trial in High Tibial Osteotomy Patients. Journal of Bone and Mineral Research, 35 (10), 1893-1903 doi:10.1002/jbmr.4107.
@article{article, author = {Chiari, Catharina and Grgurevic, Lovorka and Bordukalo‐Niksic, Tatjana and Oppermann, Hermann and Valentinitsch, Alexander and Nemecek, Elena and Staats, Kevin and Schreiner, Markus and Trost, Carmen and Kolb, Alexander and Kainberger, Franz and Pehar, Sanja and Milosevic, Milan and Martinovic, Snjezana and Peric, Mihaela and Sampath, T Kuber and Vukicevic, Slobodan and Windhager, Reinhard}, year = {2020}, pages = {1893-1903}, DOI = {10.1002/jbmr.4107}, keywords = {BMP, CLINICAL TRIALS, IMPLANTS, INJURY/FRACTURE HEALING.}, journal = {Journal of Bone and Mineral Research}, doi = {10.1002/jbmr.4107}, volume = {35}, number = {10}, issn = {0884-0431}, title = {Recombinant Human BMP6 Applied Within Autologous Blood Coagulum Accelerates Bone Healing: Randomized Controlled Trial in High Tibial Osteotomy Patients}, keyword = {BMP, CLINICAL TRIALS, IMPLANTS, INJURY/FRACTURE HEALING.} }
@article{article, author = {Chiari, Catharina and Grgurevic, Lovorka and Bordukalo‐Niksic, Tatjana and Oppermann, Hermann and Valentinitsch, Alexander and Nemecek, Elena and Staats, Kevin and Schreiner, Markus and Trost, Carmen and Kolb, Alexander and Kainberger, Franz and Pehar, Sanja and Milosevic, Milan and Martinovic, Snjezana and Peric, Mihaela and Sampath, T Kuber and Vukicevic, Slobodan and Windhager, Reinhard}, year = {2020}, pages = {1893-1903}, DOI = {10.1002/jbmr.4107}, keywords = {BMP, CLINICAL TRIALS, IMPLANTS, INJURY/FRACTURE HEALING.}, journal = {Journal of Bone and Mineral Research}, doi = {10.1002/jbmr.4107}, volume = {35}, number = {10}, issn = {0884-0431}, title = {Recombinant Human BMP6 Applied Within Autologous Blood Coagulum Accelerates Bone Healing: Randomized Controlled Trial in High Tibial Osteotomy Patients}, keyword = {BMP, 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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