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

NCT02205138 Phase 2 COMPLETED

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.

Details

Lead sponsor	Bone Therapeutics S.A
Phase	Phase 2
Status	COMPLETED
Enrolment	38
Start date	2014-10
Completion	2021-01-25

Conditions

• Degenerative Disc Disease

Interventions

• ALLOB® cells with ceramic scaffold

Primary outcomes

• Lumbar fusion progression as assessed by CT scan — 12 months
• Functional Disability using Oswestry Disability Index — 12 months
• Potential occurrence of any AE or SAE, related to the product or to the procedure, using patient open non-directive questionnaire, physical examination and laboratory measurements — 12 months

Countries

Belgium