Clinical trial NCT02328287: Study on Allogeneic Osteoblastic Cells Implantation in Rescue Interbody 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 Rescue Interbody Fusion
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Failed Lumbar Fusion
Keywords: Spinal Fusion
Revision Surgery
Pseudarthrosis
Cell Therapy
Bone Graft
Lead sponsor: Bone Therapeutics S.A
Sponsor class: INDUSTRY
First posted: 2014-12-31
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


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
* Failed lumbar fusion of 15 months minimum requiring a revision surgery at one or two levels between L1 and S1

Exclusion Criteria:

* More than two failed interbody fusions at the involved lumbar level(s)
* Instrumentation failure requiring revision surgery
* Local active or latent infection at the involved lumbar level(s)
* 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, using patient open non-directive questionnaire, physical examination and laboratory measurements
timeFrame: 36 months
Other outcomes:
Locations:
city: Anderlecht
country: Belgium
facility: Investigating site BE01
city: Charleroi
country: Belgium
facility: Investigating site BE02
city: Genk
country: Belgium
facility: Investigating site BE04
Study officials:
References: