Bone Therapeutics, a bone cell therapy company based in Brussels and Paris, has completed treatment without any safety concerns of the second cohort of patients in the ALLOB Phase I/IIA trial for patients with delayed-union fractures. The safety committee ruled unanimously that the trial can proceed as planned and can continue to enroll patients.
The study is a six-month open-label trial to evaluate the safety and efficacy of Bone Therapeutics’ allogeneic bone cell therapy product, ALLOB which is used in the treatment of delayed-union fractures of long bones
To date, eight patients with a fracture that had failed to consolidate after a minimum of three and a maximum of seven months have received a single percutaneous administration of ALLOB directly into the fracture site.
Enrico Bastianelli, CEO of Bone Therapeutics, said, “This is the first trial in which our allogeneic bone cell therapy product is being evaluated and we are pleased to have reached this important patient treatment milestone without any safety issues. We were very encouraged with the positive efficacy results previously reported from the first cohort of patients in the trial and we look forward to updating the market on the efficacy of this second patient cohort.”
One patient of the second cohort has also been included in a sub-study to investigate the bio-distribution of the ALLOB cells through the body and to confirm their presence at the fracture site after administration. By radioactively labeling a fraction of the ALLOB cells before injection, the cells can be traced up to 72 hours after administration.
