Gold Winner: Osteoplastic Cell-Based Therapy For Delayed Union Fractures

“A pilot Phase I/IIa, multicentre, open proof-of-concept study on the efficacy and safety of allogeneic osteoblastic cells (ALLOB®) implantation in non-infected delayed-union fractures”

Elisa Llinares, PhD ; Audrey Colliou, PharmD ; Enrico Bastianelli, MD, MBA

Cell-based therapy offers potential in bone regeneration for the treatment of bone diseases and orthopaedic conditions. Bone Therapeutics is developing a range of innovative regenerative products containing osteoblastic cells, administrable via a minimally invasive percutaneous technique; a unique value proposition in the market. The implantation of biologically active cells locally into the bone fracture site is intended to mimic the natural process of bone formation and eventually to create a healthy bone environment by recruiting endothelial and osteoprogenitor cells.

Traditional options for the treatment of an impaired fracture (i.e., bone graft) typically involve highly invasive surgery, which can be painful and require months of rehabilitation with the risk of serious complications (such as deep bone infection). Due to the risks of the current treatment, orthopaedic surgeons often take a “wait and see” approach to the treatment of delayed-union fractures, sometimes for months, which delays the patient’s return to a normal life and leads to a significant financial burden to society.

The Bone Therapeutics’ human allogeneic bone cell therapy product, ALLOB® is currently in a Phase I/IIA six-month open-label trial to evaluate its safety and efficacy in the treatment of delayed-union fractures of long bones. In this study, delayed-union is defined at the time of screening as an absence or a slow progression of healing of minimum 3 months and with a maximum of 7 months (± 2 weeks) after the onset of fracture.

The international ALLOB-DU1 study is targeting the recruitment of 32 patients in Belgium, Germany and the UK and could be prematurely stopped due to efficacy after an interim data analysis of the 16 first patients. Fracture healing of ALLOB®-treated patients is assessed in comparison to baseline at two weeks, one, three and six months using both clinical (e.g., pain, weight bearing) and radiological evaluation.

To date, eight patients including 2 women and 6 men with a mean age of 49 years (± 15) have received a single percutaneous administration of ALLOB® directly into their delayed-union fracture site. The delayed-unions treated so far were located on the femur (2), tibia (3), ulna (1) and humerus (2).

Preliminary results obtained with ALLOB® indicate quantitative clinical and radiological improvements for this type of non-aggressive approach for the treatment of delayed-union fractures.

ALLOB® has the potential to become a first-line and early treatment for delayed-union fractures, thanks to its minimally invasive administration which avoids the need for major surgery.

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