First Clinical Trial in Allogeneic Bone Cell Therapy Product

Minimally invasive bone forming product ALLOB® in Phase I/IIa trial for delayed union fracture

30-Jun-2014 - Belgium

Bone Therapeutics announced that the first patient has been treated with its novel allogeneic osteoblastic (bone-forming) cell therapy product ALLOB^® in its phase I/IIa study for the treatment of delayed union fractures.

ALLOB^® is the first ever allogeneic differentiated osteoblastic cell therapy product developed for the treatment of orthopaedic conditions. Allogeneic cell therapy involves the harvesting of cells from a healthy, universal donor, rather than from the patient being treated. ALLOB^® has shown safety and efficacy in preclinical studies and does not require any immunosuppressive side therapy.

This first-in-human, proof-of-concept, 6 months open-label phase I/IIa study is evaluating the safety and efficacy of ALLOB^® in the treatment of delayed union fractures of long bones. ALLOB^®-treated patients will be assessed in comparison to baseline at 2 weeks, 1, 3 and 6 months using clinical (e.g., pain, weight-bearing) and radiological evaluation. Ultimately, 32 patients with delayed union fractures will be enrolled in the study.

Enrico Bastianelli, Chief Executive Officer of Bone Therapeutics commented: “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 whilst offering delayed union patients the potential for a significant improvement in their condition without the need for invasive surgery. ALLOB^® has the potential to add significant shareholder value as it could address multiple orthopaedic conditions as a first line treatment. This first in human trial is an important milestone both for realizing benefits for the patients as well as creating value for the Company.”

https://www.bionity.com/en/news/148887/first-clinical-trial-in-allogeneic-bone-cell-therapy-product.html