Bone Therapeutics, SA, a regenerative therapy company located in Gosselies, Belgium, has treated its first patient with its allogeneic osteoblastic (bone-forming) product Allob. According to company officials, Allob is the first allogeneic differentiated osteoblastic cell therapy product to be developed for the treatment of orthopedic conditions. Treatment of this patient is part of the company’s Phase I/IIa study for the treatment of delayed union fractures.
A delayed union fracture is defined as a bone that has not healed within the expected period of time after the initial injury—three to four months—and is at risk of non-healing. Around 600, 000 to 900, 000 patients are affected by delayed union each year.
Allogeneic cell therapy involves the harvesting of cells from a healthy donor and not from the patient who is being treated. Investigators report that Allob has shown both safety and efficacy in preclinical trials and patients receiving it do not require any immunosuppressive therapy.
Bone Therapeutics officials believe that Allob has the potential to become a first-line treatment for impaired fracture healing. It is injected by the surgeon in a single dose percutaneously directly into the fracture site. No side-effects have yet been reported. Treated patients will be assessed at two weeks, one, three and six months. Researchers expect to ultimately enroll 32 patients with delayed union fractures in the study.
Enrico Bastianelli, company CEO said, “Treating a patient for the first time with our allogeneic product ALLOB is a significant step forward for the progression of Bone Therapeutics’ regenerative therapy pipeline. Our allogeneic approach will lead to an “off-the-shelf” approach to treatment while offering delayed union patients the potential for a significant improvement in their condition without the need for invasive surgery.”
