Study on Allogeneic Osteoblastic Cells Implantation in Rescue Interbody Fusion

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Study Completion Date

2020-04-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Failed Lumbar Fusion

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ALLOB® Implantation

Group Type EXPERIMENTAL

ALLOB®

Intervention Type DRUG

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

Interventions

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ALLOB®

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

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No