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

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-31

Study Completion Date

2021-01-25

Brief Summary

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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.

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Detailed Description

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Conditions

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Degenerative Disc Disease

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® cells with ceramic scaffold

ALLOB® cells with ceramic scaffold Implantation

Group Type EXPERIMENTAL

ALLOB® cells with ceramic scaffold

Intervention Type DRUG

Each patient will undergo a single administration of ALLOB®/ceramic scaffold mix into the lumbar interbody fusion site under anaesthesia

Interventions

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ALLOB® cells with ceramic scaffold

Each patient will undergo a single administration of ALLOB®/ceramic scaffold mix into the lumbar interbody fusion site under anaesthesia

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
* 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No