J Orthop Surg Res. 2019 Jul 1;14(1):198. doi: 10.1186/s13018-019-1219-5.

Autologous cell-coated particles for the treatment of segmental bone defects-a new cell therapy approach.

Ben-David D¹, Fishman B², Rubin G^3,4, Novak A², Laevsky I², Kadouri A², Nishri Katz Y², Burger O², Zaretsky A³, Bor N^3,4, Tzur E⁵, Meretzki S², Rozen N^3,4.

Abstract

BACKGROUND:

Adipose tissue-derived mesenchymal stem cells (AT-MSCs) are one of the most potent adult stem cells, capable of differentiating into bone, cartilage, adipose, muscle, and others. An innovative autologous AT-MSC-derived cell-based product (BonoFill-II) for bone tissue regeneration was developed to be suited as a bone graft for segmental bone defects.

METHODS:

BonoFill-II was transplanted into 8 sheep with 3.2-cm full cortex segmental defect formed in the tibia. Bone regeneration was followed by X-ray radiographs for 12 weeks. At experiment termination, the healed tibia bones were analyzed by computed tomography, histology, and mechanical tests.

RESULTS:

Our results indicate that one dose of BonoFill-II injectable formula led to an extensive bone growth within the transplantation site and to a complete closure of the critical gap in the sheep's tibia in a relatively short time (8-12 weeks), with no inflammation and no other signs of graft rejection. This new and innovative product opens new prospects for the treatment of long bone defects.

CONCLUSIONS:

Injection of BonoFill-II (an innovative autologous cell therapy product for bone tissue regeneration) into a critical size segmental defect model (3.2 cm), generated in the sheep tibia, achieved full bridging of the gap in an extremely short period (8-12 weeks).