Gosselies, Belgium-based Bone Therapeutics SA has expanded its Phase I/IIA delayed union clinical trial to include multifocal delayed union bone fractures.
The treatment features ALLOB, the company’s allogeneic bone cell therapy product. The addition to the original study has been approved by authorities in Belgium and Germany, according to Bone Therapeutics officials.
ALLOB is an allogeneic differentiated osteoblastic (bone-forming) cell therapy product developed for the treatment of orthopedic conditions and bone diseases. Allogeneic cell therapy involves the harvesting of cells from a healthy donor, rather than from the treated patient.
The new Phase IIA study is designed to extend the ongoing trial from the treatment of single fractures to dealing with multiple fractures. The study will enroll 12 patients, diagnosed with multiple delayed-union fractures of long bones, across six sites in Belgium and four sites in Germany.
Patients will be recruited in cohorts of four and initial safety data of each cohort will be analyzed by the Safety Monitoring Committee before recruitment of the next group of patients can take place. This is to ensure maximum patient safety.
Patients in the new trial will receive two to four percutaneous injections of ALLOB at two, three or four fracture sites on the same or different long bones, while a single dose at one site will be used in the original delayed-union study. The study will thus allow for the evaluation of the safety and efficacy of higher doses of ALLOB. Researchers will evaluate fracture healing in the ALLOB-treated patients over a six-month period using clinical and radiological parameters.
Bone Therapeutics CEO Enrico Bastianelli commented: “We are pleased to continue the progress in our clinical strategy, intended to increase the potential market for ALLOB®. This new study is the next step in the development of our delayed-union program and it will allow us to provide patients who might be facing a long road of complicated surgeries and rehabilitation with a minimally invasive alternative.”
