February 24, 2018 |
First Ever Clinical Trial of Allogeneic Bone Cell Therapy Product
June 25, 2014  | 

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. This first in human trial is an important milestone both for realizing benefits for the patients as well as creating value for the Company.”

[1] differentiated osteoblastic cells showing higher efficacy compared to undifferentiated stem cells – Undale – JOR December 2011

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