Clinical trial NCT02205138: Phase 2a Study on Allogeneic Osteoblastic Cells Implantation in Lumbar Spinal Fusion
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Degenerative Disc Disease
Keywords: Spinal Fusion
Lumbar Interbody Fusion
Degenerative Disc Disease
Cell Therapy
Bone Graft
Lead sponsor: Bone Therapeutics S.A
Sponsor class: INDUSTRY
First posted: 2014-07-31
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Lumbar fusion progression as assessed by CT scan
timeFrame: 12 months
measure: Functional Disability using Oswestry Disability Index
timeFrame: 12 months
measure: 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
timeFrame: 12 months
Secondary outcomes:
measure: Pain using a Visual Analogue Scale
timeFrame: 12 months
measure: Global Disease Evaluation using a Visual Analogue Scale
timeFrame: 12 months
measure: Functional Disability using Oswestry Disability Index
timeFrame: 12 months
measure: Lumbar fusion progression as assessed by CT scan
timeFrame: 12 months
measure: Percentage of patients having a rescue surgery
timeFrame: 12 months
measure: Potential occurrence of any AE or SAE related to the product or to the procedure
timeFrame: 36 months
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Investigating site BE01
city: Brussels
country: Belgium
facility: Investigating site BE03
city: Brussels
country: Belgium
facility: Investigating site BE05
city: Charleroi
country: Belgium
facility: Investigating site BE02
city: Genk
country: Belgium
facility: Investigating site BE04
city: Kortrijk
country: Belgium
facility: Investigating site BE08
city: Liège
country: Belgium
facility: Investigating site BE07
city: Mons
country: Belgium
facility: Investigating site BE06
Study officials:
References: