ADVANCING MESENCHYMAL CELL-BASED BONE TISSUE ENGINEERING: COMPREHENSIVE PHASE II CLINICAL TRIAL OUTCOMES OF BONOFILL™ IN MAXILLOFACIAL RECONSTRUCTION

• Published in: Cytotherapy (Oxford, England) Vol. 26; no. 6; pp. S20 - S21
• Main Authors: Tzur, E, Rozen, N, David, D. Ben, Barzilai, M. Gur, Novak, A, Kivity, V, Bronshtein, T, Meretzki, S
• Format: Journal Article
• Language: English
• Published: Elsevier Inc 01.06.2024
• Subjects: Advanced Basic Science; Bone; Graft; Other; Tissue Engineering; Graft; Bone; Tissue Engineering
• ISSN: 1465-3249; 1477-2566
• DOI: 10.1016/j.jcyt.2024.03.493

Background & AimBone tissue engineering stands as a principal area of research in mesenchymal cell-based regenerative medicine. The aim is to develop a viable alternative to autologous bone grafting, currently marked by procedural complexities and high failure rates. Bonus Biogroup has been at the forefront of this effort with our innovative product, BonoFill™. This tissue-engineered bone graft utilizes a biodegradable mineral scaffold in an injectable formulation to deliver a three-dimensional culture of hemi-differentiated autologous mesenchymal cells. These cells range from multipotent cells to mature osteoprogenitors, offering capabilities beyond mere bone rebuilding; they support vascularization and graft integration. This abstract presents interim results from our Phase II clinical trials for treating complex maxillofacial bone deficiencies, traditionally treated with autologous bone grafting. All transplantations in this trial have been completed, and the final results will be presented during ISCT 2024. Concurrently, another Phase II clinical trial is ongoing to address critical-sized limb bone defects. Methods, Results & ConclusionIn the Phase II study, subjects with maxillofacial bone deficiencies received BonoFill™ following cyst removal (Fig. 1A) or for sinus augmentation (Fig. 1B). Thirty bone defects were treated with over 14cc of BonoFill™ demonstrating a satisfactory safety profile. Based on 20 out of 30 procedures for subjects who completed the six-month follow-up period, successful bone regeneration was noted in 18/20 treated bones, enabling further reconstructive procedures. The bone height at the graft sites showed an average increase of 9.2±1.2 mm ( p<0.0001), resulting in a final average bone height of 14.3±1.3 mm. Notably, this bone augmentation was already apparent three months post-transplantation (Fig. 1C), indicating rapid regeneration and successful graft integration. Biopsies taken six months post-treatment from the graft sites revealed healthy bone formation, abundant vascularization, and no inflammation (Fig. 2). The complete success of BonoFill™, evident in 90% of the cases, along with its safety, marks a formidable solution for complex bone deficiencies. Supported by promising results from a concurrent Phase II trial focusing on critical-sized limb bone defects, the results presented during ISCT 2024 represent a significant milestone in mesenchymal cell-based bone tissue engineering.