First Clinical Trial in Allogeneic Bone Cell Therapy Product
Minimally invasive bone forming product ALLOB® in Phase I/IIa trial for delayed union fracture
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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.”
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