Bone Therapeutics completed recruitment for its ALLOB® allogeneic cell therapy Phase IIA spinal fusion study. The company will extend the trial to assess early onset of bone formation and fusion.
Of 18 patients enrolled, 16 were eligible and 15 received treatment, with no treatment-related safety concerns reported.
The extension is designed to assess detailed dynamics of the fusion, treating 16 patients with follow-up at 3, 6 and 12 months.
Bone Therapeutics’ approach implants an interbody cage between damaged vertebrae, which is supplemented with ALLOB plus bioceramic granules. Preclinical results demonstrated that the combination significantly increased fusion vs. use of bioceramics alone.
Efficacy data from the first four patients is expected by the end of 2Q16, with complete efficacy results slated for delivery in 2Q17.
Other ALLOB studies underway include treatment of multiple delayed-union fractures, delayed-union fractures and the revision of failed spinal fusion.
Bone Therapeutics completed recruitment for its ALLOB® allogeneic cell therapy Phase IIA spinal fusion study. The company will extend the trial to assess early onset of bone formation and fusion.
Of 18 patients enrolled, 16 were eligible and 15 received treatment, with no treatment-related safety concerns reported.
The extension is designed...
Bone Therapeutics completed recruitment for its ALLOB® allogeneic cell therapy Phase IIA spinal fusion study. The company will extend the trial to assess early onset of bone formation and fusion.
Of 18 patients enrolled, 16 were eligible and 15 received treatment, with no treatment-related safety concerns reported.
The extension is designed to assess detailed dynamics of the fusion, treating 16 patients with follow-up at 3, 6 and 12 months.
Bone Therapeutics’ approach implants an interbody cage between damaged vertebrae, which is supplemented with ALLOB plus bioceramic granules. Preclinical results demonstrated that the combination significantly increased fusion vs. use of bioceramics alone.
Efficacy data from the first four patients is expected by the end of 2Q16, with complete efficacy results slated for delivery in 2Q17.
Other ALLOB studies underway include treatment of multiple delayed-union fractures, delayed-union fractures and the revision of failed spinal fusion.
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