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

Bone Therapeutics

Status and phase

Completed

Phase 2

Conditions

Degenerative Disc Disease

Treatments

Drug: ALLOB® cells with ceramic scaffold

Study type

Interventional

Funder types

Industry

Identifiers

NCT02205138

ALLOB-IF1

Details and patient eligibility

About

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.

Enrollment

38 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Ability to provide a written, dated, and signed informed consent prior to any study related procedure, and to understand and comply with study requirements
Symptomatic degenerative disc disease of the lumbar spine requiring a single level lumbar fusion (L1-S1)
Unresponsive to non-operative treatment for at least 6 months

Exclusion criteria

Lumbar disc disease requiring treatment at more than one level
Previous failed fusion at the involved lumbar level
Local active or latent infection at the involved lumbar level
Positive serology for hepatitis B, hepatitis C, HIV
Current or past medical disease that could interfere with the evaluation of the safety and efficacy, as judged by the investigator