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

Đurđević, Dragan; Vlahović, Tomislav; Pehar, Sanja; Miklić, Dina; Oppermann, Hermann; Bordukalo-Niksic, Tatjana; Gavrankapetanović, Ismet; Jamakosmanovic, Mehmed; Milošević, Milan; Martinović, Snježana; Sampath, T. Kuber; Perić, Mihaela; Grgurević, Lovorka; Vukičević, Slobodan

doi:10.1016/j.bone.2020.115551

Cited by 25 publications

(17 citation statements)

References 31 publications

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“…Patients treated with rhBMP6/ ABC showed enhanced bone healing in comparison to PBO and SoC at 5 and 9 weeks. Finally, we showed that intraosseous use of ABGS in the distal radial fracture site accelerated the cancellous bone repair without any serious adverse events 14 .…”

Section: Distal Radial Fracture Healing Studymentioning

confidence: 78%

“…The novel ABGS osteogenic device accelerates bone repair and contains compatible blood coagulum carrier, thus limiting inflammatory reaction contrary to other BMP based bone devices. BMP6 is used in a small dose with the ABC carrier and enhanced bone formation in preclinical studies 14,[135][136][137][138] (Figs. 1, 3, and 4).…”

Section: Commercial Bmp-based Bone Implantsmentioning

confidence: 99%

“…In clinical trials we tested whether the low quantities of BMP6 in an autologous carrier support trabecular bone healing of the compartment in which BMP2 and BMP7 were ineffective 14,15 . ABGS has so far been tested in Phase I study in patients with distal radial fractures 14 and Phase I/II study in patients undergoing high tibial osteotomy 15 .…”

Section: Clinical Studies Using Abgsmentioning

confidence: 99%

“…Thus, the animal-derived collagen has been replaced with ABC which reduces the inflammatory response and serves as a physiological carrier for rhBMP6 adjustable to the desired shape 11,12 . Based on the results from the preclinical studies, clinical studies/trials in patients with a distal radial fracture, high tibal osteotomy and posterolateral spinal fusion were approved [13][14][15] . This review covers BMP discovery, biology and their use in clinical studies with particular reference to new BMP6 based ABGS.…”

Section: Introductionmentioning

confidence: 99%

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Bone morphogenetic proteins: From discovery to development of a novel autologous bone graft substitute consisting of recombinant human BMP6 delivered in autologous blood coagulum carrier

Vukičević¹,

Perić²,

Oppermann³

et al. 2020

Rad Hrvatske akademije znanosti i umjetnosti

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Bone Morphogenetic Proteins (BMPs) are growth and differentiation factors within the TGFβ superfamily of proteins. They induce ectopic and orthotopic endochondral bone formation and are involved in the regulation of cell proliferation, differentiation, apoptosis and mesenchymal-epithelial interactions in critical morphogenetic processes of tissues beyond bone. BMP2 and BMP7 osteogenic devices have been approved for enhancing healing in patients with long bone defects and anterior spinal fusion procedures. However, due to a high price and various serious adverse events including heterotopic ossification, retrograde ejaculation and pain their clinical use have been limited. In this review we discuss the BMP discovery, biology and their use in clinical studies with particular reference to the newly developed BMP6 based autologous bone graft substitute (ABGS). A novel ABGS consisting of an autologous bone coagulum (ABC) carrier with dispersed BMP6 to initiate the differentiation of mesenchymal cells into endochondral bone. The ABC met the conditions for an optimal delivery system for BMP6 due to handling simplicity, without an immunogenic and inflammatory response at the implantation site. Addition of allograft or synthetic ceramics to ABGS demonstrated in animal models significantly increased volume

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Section: Distal Radial Fracture Healing Studymentioning

confidence: 78%

Section: Commercial Bmp-based Bone Implantsmentioning

confidence: 99%

Section: Clinical Studies Using Abgsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

See 2 more Smart Citations

Bone morphogenetic proteins: From discovery to development of a novel autologous bone graft substitute consisting of recombinant human BMP6 delivered in autologous blood coagulum carrier

Vukičević¹,

Perić²,

Oppermann³

et al. 2020

Rad Hrvatske akademije znanosti i umjetnosti

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“…We have recently developed an autologous bone graft substitute (ABGS) comprised of BMP6 delivered within an autologous blood coagulum to which a compression-resistant matrix, such as allograft or synthetic ceramics, can be added [22,73,74,76,[86][87][88][89][90][91][92]. Moreover, the volume of newly induced bone increased with the elevation of the CRM amount, which might be attributed to the enlargement in an overall surface area [73].…”

Section: Bone Regeneration By Bone Morphogenetic Protein Devicesmentioning

confidence: 99%

Bone Morphogenetic Proteins, Carriers, and Animal Models in the Development of Novel Bone Regenerative Therapies

et al. 2021

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Bone morphogenetic proteins (BMPs) possess a unique ability to induce new bone formation. Numerous preclinical studies have been conducted to develop novel, BMP-based osteoinductive devices for the management of segmental bone defects and posterolateral spinal fusion (PLF). In these studies, BMPs were combined with a broad range of carriers (natural and synthetic polymers, inorganic materials, and their combinations) and tested in various models in mice, rats, rabbits, dogs, sheep, and non-human primates. In this review, we summarized bone regeneration strategies and animal models used for the initial, intermediate, and advanced evaluation of promising therapeutical solutions for new bone formation and repair. Moreover, in this review, we discuss basic aspects to be considered when planning animal experiments, including anatomical characteristics of the species used, appropriate BMP dosing, duration of the observation period, and sample size.

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Synthetic ceramic macroporous blocks as a scaffold in ectopic bone formation induced by recombinant human bone morphogenetic protein 6 within autologous blood coagulum in rats

Štoković

Ivanjko

Milešević

et al. 2020

International Orthopaedics (SICOT)

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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

Cited by 25 publications

References 31 publications

Bone morphogenetic proteins: From discovery to development of a novel autologous bone graft substitute consisting of recombinant human BMP6 delivered in autologous blood coagulum carrier

Bone morphogenetic proteins: From discovery to development of a novel autologous bone graft substitute consisting of recombinant human BMP6 delivered in autologous blood coagulum carrier

Bone Morphogenetic Proteins, Carriers, and Animal Models in the Development of Novel Bone Regenerative Therapies

Synthetic ceramic macroporous blocks as a scaffold in ectopic bone formation induced by recombinant human bone morphogenetic protein 6 within autologous blood coagulum in rats

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