drugset / Trial / NCT02205138

Phase 2a Study on Allogeneic Osteoblastic Cells Implantation in Lumbar Spinal Fusion

NCT02205138 ↗

Phase 2 Completed 38 enrolled Bone Therapeutics S.A
NaSingle-groupOpen-labelTreatment

Summary

Among existing surgical techniques, spinal fusion is considered as the gold standard to treat a broad spectrum of degenerative spine disorders, including spondylolisthesis and scoliosis, with regard to pain reduction and functional improvement. However, pseudarthrosis and failure to relieve low back pain are unfortunately still frequent, irrespective of the type of procedures and grafts used by the surgeon. The present Phase 2a study aims at demonstrating the safety and efficacy of ALLOB®, a proprietary population of allogeneic osteoblastic cells, in lumbar spinal fusion.

Timeline

Start
2014-10
Primary completion
2019-02
Completion
2021-01-25

Drugs

EvaluationDrugModalityDoseRoute
Subject ALLOB® Cell therapy — Other