Bone Therapeutics has presented pre-clinical and positive early clinical efficacy data of its Allob Phase IIA spinal fusion trial. These preliminary data, presented at the Clinical Applications of Stem Cells Conference, 24-25 February 2016 in Singapore, show spinal fusion on computed tomography (CT) scans and absence of intervertebral motion on dynamic x-rays.
Bone Therapeutics is investigating a unique approach where the interbody cage is implanted according to the standard-of-care surgical approach and supplemented with Allob in combination with bioceramic granules. Preclinical results demonstrated that the combination of bioceramics with Allob cells significantly increased new bone formation and fusion in comparison with bioceramics alone.
Safety and efficacy of the implantation of ALLOB cells mixed with bioceramic granules in lumbar spinal fusion is evaluated in the ongoing pilot Phase IIA study with Allob using clinical and radiological parameters. In this proof-of-concept study, the first out of 12 patients treated has now completed the 12-month follow-up period. The presence of bone bridges between the vertebrae was demonstrated on CT scans as early as six months after treatment and dynamic x-rays revealed the absence of motion of the vertebral bodies, indicating a successful fusion. In addition, this patient experienced pain relief six months after the treatment, as assessed by the Visual Analogue Scale questionnaire.