NCT02205138

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

A Pilot Phase 2a, Multicentre, Open, Proof-of-concept Study on the Safety and the Efficacy of Allogeneic Osteoblastic Cells (ALLOB®) Implantation in Lumbar Spinal Fusion

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 38 (actual)
• Sponsor: Bone Therapeutics S.A · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Degenerative Disc Disease

Interventions

Type	Name	Description
DRUG	ALLOB® cells with ceramic scaffold	Each patient will undergo a single administration of ALLOB®/ceramic scaffold mix into the lumbar interbody fusion site under anaesthesia

Timeline

• Start date: 2014-10-01
• Primary completion: 2019-02-01
• Completion: 2021-01-25
• First posted: 2014-07-31
• Last updated: 2021-01-29

Locations

8 sites across 1 country: Belgium