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

NCT02205138 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2021-01-29

No results posted yet for this study

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.

Conditions

  • Degenerative Disc Disease

Interventions

DRUG

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

Sponsors & Collaborators

  • Bone Therapeutics S.A

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-10-31
Primary Completion
2019-02-28
Completion
2021-01-25

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02205138 on ClinicalTrials.gov