TG-B is an allogeneic (donor) cell therapy that involves allogeneic (donor) human chondrocytes modified to produce the therapeutic growth factor BMP-2 in order to induce the regeneration of bone. The modified human chondrocytes have been irradiated prior to dosing to render them replication incompetent and have the potential to treat a variety of bone fractures and joint fusions. These types of disorders frequently occur in senior citizens and individuals with decreased bone mass density as frequently seen in diabetics, post-menopausal women, osteoporotics and those who are undergoing chemotherapy.
TissueGene has successfully developed several cell lines as product candidates for TG-B, which have been shown to stimulate bone growth in several animal models with segmental defects. The company is currently developing a pivotal efficacy study to evaluate the ability of TG-B to accelerate new bone formation in an impaired bone healing animal model with a critical size defect.
Technology Platform: Cell therapy
Therapeutic Protein: BMP-2
Function: Bone regeneration
Indication: Fractures & joint fusions (ankle/hindfoot)
Development Stage: Preclinical