NCT02328287

Study on Allogeneic Osteoblastic Cells Implantation in Rescue Interbody Fusion

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Bone Therapeutics S.A · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Failed fusion and failure to relieve back pain following spinal fusion are still frequent, irrespective of the type of procedures or grafts used by the surgeon. Moreover, revision surgeries are unfortunately associated with higher procedure-related complication rates, technical difficulties, longer operative time, and quite disappointing and unreliable success rates for both fusion and clinical results. The present Phase 2a study aims at demonstrating the safety and efficacy of ALLOB®, a proprietary population of allogeneic osteoblastic cells, in rescue interbody fusion.

Conditions

• Failed Lumbar Fusion

Interventions

Type	Name	Description
DRUG	ALLOB®	Each patient will undergo a single administration of ALLOB® into the failed fusion lumbar level under anesthesia.

Timeline

• Start date: 2014-09-01
• Primary completion: 2018-04-01
• Completion: 2020-04-01
• First posted: 2014-12-31
• Last updated: 2020-06-11

Locations

3 sites across 1 country: Belgium